Showing posts with label Pharmaceutical Software. Show all posts
Showing posts with label Pharmaceutical Software. Show all posts

PharmaExpert - Pharmacology Software

PharmaExpert analyzes the relationships between biological activities, the interactions of drugs and the multiple targeting actions of chemical compounds. As a pharmacological knowledge-based tool, it provides in silico screening of compounds using PASS prediction results.

Details
Key features of PharmaExpert:
• Mechanism-effect relationship (MER) base, manually curated by experts, contains 11,049 mechanism-effect relationships
• Selection of compounds with required therapeutic but without side effects
• Comparative analysis of compounds with similar structures
• Selection of compounds with multiple mechanisms of action
• Analysis of drug-drug interactions with regard to their pharmacokinetic, pharmacodynamic and adverse effects

PharmaExpert is an addition to the PASS (Prediction of Activity Spectra for Substances) tool. It provides a comfortable solution for data mining of the PASS prediction results to find the best drug-like candidates from a set of compounds. The core of the program is a mechanism-effect relationship (MER) base, manually curated by experts, which is used to determine cause-effect relationships for the compounds. Like PASS, the software runs under Windows.

PharmaExpert has been developed by Vladimir Poroikov, Dmitry Filimonov & Associates currently working in the Department for Bioinformatics at the Institute of Biomedical Chemistry, Russian Academy of Medical Sciences in Moscow.

A free demo version, as well as further information, is available upon request.

Software Link: PharmaExpert - Pharmacology Software
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Metabase - laboratory data management software

Metabase is a laboratory data management software system designed specifically to meet the needs of laboratories conducting ADME metabolism, pharmacokinetics, and toxicokinetics studies. Starting with the generation of a sample list for an entire study, Metabase serves as the basic tool to acquire, organize, manage, calculate, store, and report study results. Key features of the program are its clear organization (which follow standard laboratory workflow procedures), its flexible and powerful data handling, its ease of use, and its integration with other productivity software. The flow sheet on the right illustrates the overall process of using Metabase as your primary data handling and management system.

Metabase is a practical, low cost, user-friendly, laboratory-oriented tool. The program is based on Microsoft Excel® and can be easily custom tailored to fit each client's work place or modified to meet changing needs and requirements. And to make sure that it does the job the right way, it was designed and operated in radio-analytical metabolism research laboratories.

Metabase comes as a turn-key system for radio-analytical sample processing and liquid scintillation counting data, but it can be custom modified for other analytical methods. Metabase is designed to meet GLP guidelines and comply with FDA, EPA, EEC software development and validation requirements. The system is provided with complete system life-cycle documentation. Test files are supplied for use in validation. Metabase is a cost-effective solution for comprehensive management of metabolism information in a well organized, flexible, and user-oriented manner.

Benefits

Specifically designed for sample handling of ADME metabolism and pharmacokinetic studies.
Excel-based software providing wide flexibility in a familiar spreadsheet environment.
An exceptionally affordable LIMS system for radioanalytical lab.
Helps you define, collect, manage, calculate, and report entire study protocols.

Features

Excel-based for Reliable Performance

Metabase is based on Microsoft Excel® and can run in any version of Excel in versions of Microsoft Windows. Excel provides a familiar working environment for using Metabase. Additionally, Metabase can take full advantage of all the functions, features and power of Excel.

Flexibility

The need for flexibility is an overriding requirement for any metabolism data handling system. No two studies are exactly alike. Therefore, every function of Metabase is designed with flexibility in mind. Added to this, the "open architecture" afforded by Excel spreadsheet operations allows user control over such features as formatting and appearance, significant figures, and exporting of results. Input functions and calculations can be modified or added, as needed.

Lab Smart

Metabase is a "lab smart" tool. It was developed by researchers with extensive experience in metabolism studies and is designed to provide assistance through all phases of a typical metabolism study.

Protocol and Study Designs

Metabase can handle any type of study design, whether the study involves serial sampling of individual animals, time-based composites from groups of animals, multiple dose levels, or even variable specific activities. Metabase helps the user set up a clear one-page overview of the study design and sampling strategy and uses this to develop a master sample information database.

Variable Dose Methods

Metabase supports dose computations based on individual dose measurements or nominal dose amounts per group. Additionally, different specific activities can be used for each dose group, such as employed in EPA's guidelines for dermal absorption studies.

Automated Data Entry

No hand entries of data. Metabase automatically reads data files obtained from a liquid scintillation counter or it can be directly connected for on-line data transfer. Similarly, Metabase automatically prepares a Sample Processing spreadsheet that can be linked to auto-balances for direct transfer of weight measurements.

Sample Processing

Metabase incorporates unique features to help you manage both your samples and your data from collection to counting. Special algorithms summarize laboratory processes and provide a consistent method for gathering and processing quantitative measurements, regardless of the number and complexity of sample processing procedures. Automated balances and robot-controlled processing stations can serve as data inputs. Volumetric measurements can be gathered electronically or entered directly into electronic forms.

Adaptable and Expandable

The primary design is to provide acquisition of LSC and auto-balance or robot-processing data. However, Metabase can be extended or modified to acquire quantitative results from other analytical instruments. In fact, due to its modular nature, the program can be customized to provide data management support for other disciplines besides metabolism.

High Throughput

There are practically no limits to the number of study animals, sample types, or time points that can be assembled in a single study. A single data file can handle approximately 16,000 records, and multiple files can be used in a study

Radioactivity Calculations

A built-in calculation module provides initial dose calculations such as the amount of total dose and radioactivity required, the limit of detection and analytical sensitivity for a given specific activity, and other useful values.

Pharmacokinetics

Metabase results can be passed directly to PK Solutions, Summit's powerful pharmacokinetics data analysis program. This program generates all commonly reported PK parameters from blood levels obtained after single, multiple, and infusion dose regimens.

Report Generation

Automatically prepares data tables with appendix and report quality formats, including color, if desired. User-selectable output choices and data arrangement. Metabase data outputs can be custom tailored for specific analysis routines or for advanced document preparation.

Custom Design

Metabase is designed to fulfill core functions associated with metabolism sample management and data acquisition, analysis and reporting functions. Typical installation in the client laboratory involves custom modifications to insure that the program fits with individual client procedures, needs, and requirements.

QA and GLP Compliant

Metabase is designed to comply with GLP guidelines and to facilitate QA data reviews. In addition to built-in data protection and automatic audit trails, the laboratory may choose among several alternatives for managing authorized entry and use.

SDLC Documentation

Metabase comes with a complete system development life cycle documentation package to make validation a breeze. The minimum validation documentation set includes Requirements Analysis, System Design Specifications, Version History, Source Code, User Manual, Test Procedures, and Test Files. All documentation is also supplied both in hard copy and as a formatted Word file for on-line viewing in color.

Usability

Metabase is a colorful, fast and fun application to use. It was designed to give you maximum control over your data in a logical and straight forward manner.

Portability

Metabase files can easily be transported on diskettes or other portable medium (or via e-mail) to be worked on anywhere.

Economical

The cost of equipping a laboratory with a custom installed Metabase system is a fraction of the cost of competing systems. The reason is because we take advantage of the power and breadth of Excel to both maximize your options and minimize your costs.

Software Link:  Metabase - pharmacokinetics/ toxicokinetics Software
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PASS - Pharmacology Software

The acronym PASS stands for Prediction of Activity Spectra for Substances. After entering structural formulas of organic compounds - either a single structure or a big library - the program instantly gives a list of predicted bioactivities, accompanied by estimated mathematical probabilities.
Details

Key features of PASS:
• Chemical structures are represented with Multilevel Neighborhood of Atoms (MNA) descriptors
• Activity spectra for libraries of compounds can be predicted within minutes
• Atoms of every structure are colored according to their contribution to the chosen activity
• Possibility to create and train own SAR bases and to modify the included SAR base
• Currently, 4,444 bioactivities can be predicted with the included SAR base
• Mathematical algorithm based on Bayesian estimates of probabilities

PASS can quickly predict biological activity spectra for organic drug-like compounds qualitatively. The activities that can be predicted range from pharmacotherapeutic effects, biochemical mechanisms and toxic and adverse effects to influence on the metabolism, gene regulation and transporter-related activities. The software runs under Windows.

PASS has been developed by Vladimir Poroikov, Dmitry Filimonov & Associates currently working in the Department for Bioinformatics at the Institute of Biomedical Chemistry, Russian Academy of Medical Sciences in Moscow.

A free demo version, as well as further information, is available upon request.

Software Link :  PASS - Pharmacology Software
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GastroPlus - Pharmacology Software

GastroPlus™ is a mechanistically based simulation software package that simulates intravenous, oral, oral cavity, ocular, intranasal and pulmonary absorption, pharmacokinetics, and pharmacodynamics in humans and animals. This smoothly integrated platform combines a user-friendly interface with powerful science to help you make faster ad more informed project decisions. GastroPlus™ is by far the most commonly used software of its kind!


The GastroPlus simulations include:

NEW! Drug-Drug Interactions (with optional DDI Module)
NEW! Models for predicting drug administration through ocular or pulmonary routes (with optional Additional Dosage Routes Module)
• Whole-body physiological models for human (fasted and fed), beagle dog (fasted and fed), rat (fasted and fed), mouse (fasted and fed), and cyno monkey
• Variety of dosage forms: intravenous (bolus or infusion), immediate release (tablet, capsule, suspension, solution, lingual spray, and sublingual tablet), and controlled release (gastric retention, dispersed release, integral tablet, enteric coated tablet and capsule, and buccal patch)
• Peff converter to convert user-measured permeability to human in vivo Peff
• pH-dependent solubility and logD models
• Mechanistic effect of bile salts on in vivo drug solubility and dissolution
• Enhanced treatment of nanoparticle effects on solubility and dissolution
• Dissolution and precipitation dependence on particle size, shape and particle density
• Chemical degradation of drug in intestinal lumen prior to absorption
• Enterohepatic circulation
• Parameter Sensitivity Analysis - test sensitivity of results to changes in any model parameters
• Virtual Trials - predict likely population distributions of PK/PD results
• Ability to fit one-, two-, or three-compartment conventional pharmacokinetic models to IV and/or oral data (with optional PKPlus Module)
• Physiologically based pharmacokinetics (with optional PBPKPlus Module)
• Automated model fitting for single or multiple data sets (with optional Optimization Module)
• Saturable metabolism and active transport in gut or other tissues and metabolite tracking (with optional Metabolism and Transporter Module)
• Advanced In Vitro - In Vivo Correlation for immediate or controlled release formulations (with optional IVIVCPlus Module)
• Structure-based predictions of biopharmaceutical parameters required for GastroPlus simulations (with optional ADMET Predictor Module)
• Pharmacodynamic modeling (PK/PD or PBPK/PD) with industry standard models (with optional PDPlus Module)

Software Link:  GastroPlus - Pharmacology Software
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PK Solutions - pharmacokinetic Analysis software

PK Solutions is an automated Excel-based program that does single and multiple dose pharmacokinetic data analysis of concentration-time data from biological samples (blood, serum, plasma, lymph, etc.) following intravenous or extravascular routes of administration. The program provides comprehensive tables of the most widely used and published pharmacokinetic parameters with the ease of a few mouse clicks. PK Solutions calculates results using noncompartmental (area) and compartmental (exponential terms) methods without presuming any specific compartmental model. Multiple dose and steady state parameters are automatically projected from single dose results.

The distinguishing features of PK Solutions are that it is easy, fast, and comprehensive. The program works with both concentration-time data and imported exponential terms. PK Solutions produces instant results suitable for
novice and experts, without the need for programming.

Benefits

The easiest pharmacokinetics data analysis software available.
Excel-based program provides wide flexibility in a familiar spreadsheet environment.
Provides graphs and tables of all the most widely used pharmacokinetic parameters.
Helps you analyze, record, compare, and report pharmacokinetic and ADME study results.

Features

Easy to Use

PK Solutions makes pharmacokinetic data analysis easy and fast. No programming required. Simply enter your data and with a few mouse clicks on the analysis sheet you are done. PK Solutions instantly computes and displays attractive graphs and tables of results.

Suits All Levels of Pharmacokinetic Experience

PK Solutions is used in over 40 countries by researchers, clinicians, students, and others at all skill levels who need a reliable and easy way to get pharmacokinetic data. Whether you need PK data daily or only for an occasional report, PK Solutions gives the needed results for the novice and professional user.

Comprehensive Coverage of PK Parameters

PK Solutions computes more PK parameters than any other program. More than 75 single and multiple dose pharmacokinetic results are computed from intravenous or extravascular dose data. PK parameter calculations are based on two standard methods of analysis: (1) curve-stripping (or method of residuals) to derive the exponential terms that describe the blood level curve, and (2) area under the curve calculations. PK Solutions applies both methods where applicable and compares the results side-by-side.

User Interaction with Dynamic Updates

All graphs and formulas are dynamically linked affording instant updates and immediate feedback when exploring the effect of changes in data or other inputs. For example, changing a dose interval gives an immediate redraw of the multiple dose blood level curve. Explore 'What if?' questions. Dynamic interaction helps you grasp the principles of pharmacokinetic analysis.

Record Changes - Compare Multiple Data Sets

Capture a complete listing of over 75 PK parameters for each data set. You can capture and compare the results of up to 256 data sets on a single, flexible form. A menu allows selection of parameter groups to be displayed and printed. Print reports, data tables, and graphs in color or black and white. Export or copy results and graphics for inclusion in presentations or formal reports.

Built-in Validation

PK Solutions includes the results of seven test data sets taken from the literature. Comparison of the literature values with those obtained by PK Solutions assures the scientific validity of the program. The test data can also be used to verify the reproducibility of calculations and the performance of the software. PK Solutions is used in hundreds of regulated laboratories throughout the world.

Excel-Based for Maximum Flexibility and Usefulness

PK Solutions is a Microsoft Excel program that can run on PCs using any version of Windows (Windows 3.x, 9x, NT/2000, XP) as well as on Macintosh computers. Excel provides a familiar working environment with extraordinary capabilities for additional analyses, importing and exporting of data, and interaction with other software. PK Solutions can be integrated with other Microsoft Office documents, databases, and intranet platforms. Reports and presentations of the results is easily accomplished using standard Office procedures.

Complete User Guide

The PK Solution 2.0 User Guide is a complete manual supplied in an attractive notebook. The guide clearly describes and illustrates all program options and features. In addition, the guide includes a description of all the pharmacokinetic parameters, graphing functions, and formulas used by the program thereby providing a useful compilation of pharmacokinetic equations in one place. See the PK Equations page for an excerpt from the guide describing the pharmacokinetic calculations used

Software Link:  PK Solutions - pharmacokinetic Analysis software
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ADMET Predictor - Pharmacology Software

ADMET Predictor™ is an advanced computer program that enables pharmaceutical researchers to rapidly estimate a number of ADMET properties of new chemical entities (NCE's) from their molecular structure. ADMET Predictor™ models have been consistently ranked as the most accurate in independent published comparisons.


What makes ADMET Predictor unique?

ACCURACY: its predictive models have been consistently ranked as the most accurate by independent third party comparisons.
SPEED: it can process up to ~200,000 compounds per hour on a notebook PC.
EASE OF USE: using the program is as simple as opening a file containing molecular structures.
OUTPUT OPTIONS: it provides a variety of output channels to store, transfer, or visualize its results quickly and efficiently.
BATCH CAPABILITY: it has a built-in batch mode and can run as a Pipeline Pilot™ component.
NOVEL DESCRIPTORS: it features a unique collection of rapid estimates of quantum mechanical descriptors of electronic density and reactivity at both atomic and molecular levels - a result of federally funded 3-year research project.

Software Link:  ADMET Predictor - Pharmacology Software
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ToxExpress - Toxicology Software

ToxExpress® Program is a flexible and enabling program that brings the power of toxicity-based gene expression coupled with classical toxicology endpoints to lead optimization and drug safety studies.

Toxicogenomic profiling can accelerate the pace of uncovering critical information before making significant investments into Preclinical studies. The use of microarrays to examine gene expression profiles of compounds in animal systems, when benchmarked to large reference data sets, helps establish accurate predictive methods that identify potential toxic liabilities, even in the absence of overt injury. In addition, Gene Logic's ToxExpress® Program helps to streamline, focus and augment subsequent classical studies through specialized applications that support key research areas of predictive, investigative, and mechanistic toxicology as well as safety biomarker discovery.

The products and services that comprise our ToxExpress® Program can transform and augment your critical Preclinical toxicological programs. With one service provider, you have direct access to the full spectrum of compound safety assessment technologies, providing powerful, innovative ways of resolving drug development questions and enabling targeted compound decisions.

Software Link : ToxExpress -  toxicology Software
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Software to analyse Pharmacokinetics - Phoenix® WinNonlin®

Phoenix® WinNonlin® - Next Generation of the Industry Standard for PK/PD Modeling and NCA

Phoenix WinNonlin improves scientific productivity during critical drug development tasks by providing a comprehensive analysis environment that implements efficient reusable workflows and high quality outputs while reducing barriers to learning and collaboration, enabling more impactful quantitative decision making.

Phoenix WinNonlin offers the following benefits:

Comprehensive Analysis Environment: Perform virtually all of the analyses for standard PK and PK/PD studies.
Efficient Workflow Management: Create, reuse, and share analyses as stored workflows. Easily process, visualize, and tabulate data while allowing the flexibility to edit in Excel.
High Quality Outputs: Generate high-quality graphs, tables, and figures allowing for integrated communication of analysis results.
Easy to Learn and Share: Minimize the amount of time spent learning the software and promote collaboration through easily transferable project files, workflows, and templates.
Enables Compliance: Provide technical controls for 21 CFR Part 11 compliance when used in conjunction with Pharsight Knowledgebase Server™.
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Software to analyse Pharmacokinetics - Phoenix® NLME™

Phoenix® NLME™ - Powerful New Data Processing and Modeling Tools for Population PK/PD Analysis

Phoenix NLME provides data processing and modeling tools for population PK/PD analysis. With a visual workflow engine, high quality graphics, and an easy to use graphical user interface, population PK/PD modeling has never been this accessible, flexible, and powerful.

Phoenix NLME shortens the learning curve for drug development scientists to make initial use of population modeling methods, and also provides cutting edge tools required by advanced modelers.

Phoenix model objects make Phoenix NLME both powerful and easy to use. Start with a built-in model, selecting model configuration options such as number of compartments and route of administration. Optionally modify the model graphically or fine tune the model using the Phoenix Modeling Language (PML). Specialized problems can even be handled through a user defined log-likelihood function.

All or part of your modeling workflows can be copied and pasted into new workflows or saved as templates and reused using different data thus saving time and increasing productivity.

Model building efforts are supported by built-in tools for covariate modeling, model evaluation, and model comparison. Start with a structural model and graphically evaluate the effects of covariates. Perform covariate search to automatically select the best model based on a specified improvement of a particular criterion. Create a report that compares several models? goodness of fit plots and statistics. See a record of your modeling efforts in a display that shows model nesting structure and statistical comparisons.

Phoenix NLME includes the following engines: FO, FOCE (ELS and Lindstrom-Bates), Laplacian, adaptive Gaussian quadrature, naive pooled and iterative two-stage as well as a sophisticated non-parametric algorithm.

All Phoenix NLME engines are parallelized, to take advantage of new multi-core processors. With some customization, Phoenix NLME can be configured to work on grids and clusters.

NEW! Easy to configure Job Management System frees up the user's computer by allowing the execution of Phoenix jobs remotely on Windows servers.
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Software to analyse Pharmacokinetics - acslX

acslX is a powerful and flexible modeling tool that provides a seamless modeling approach from discovery through clinical trials. acslX provides the ability to perform classical pharmacokinetic (PK) physiologically based pharmacokinetic (PBPK) and pharmacodynamic (PD) modeling, giving you the right tool at each stage of the drug development process. With acslX, you can speed drugs to market.

acslX provides a flexible Pharmacokinetic modeling tool that predicts drug dispersion and residual drug levels for toxicity and therapeutic threshold analysis. acslX supports both classical and compartmental models so that there is no limit on model simplicity or complexity. Studies are fast and reliable because acslX provides an intuitive user interface along with robust model development, execution, and analysis capabilities. acslX enables users to continuously apply new information to established models and to easily create novel models for new drug products.

acslX's Optimum software enables researchers to take modeling and simulation to the next level. Optimum is fully integrated with acslX and provides powerful analytical capabilities including parameter estimation, model optimization, sensitivity analysis, and Monte Carlo analysis. Not only that, but intuitive wizards simplify input and completely eliminate the need for type-in commands.

acslX lets you conduct sophisticated PK/PBPK/PD analysis without having to be a model developer. Using models with intuitive point-and-click interfaces, acslX is ideal for production use, providing a cost effective solution for advanced PK/PBPK/PD model analysis. acslX provides full model execution and analysis capabilities by incorporating pre-built models available from AEgis, your internal development staff, or a third party. Combine acslX intuitive interfaces with its sophisticated development environment, and you get the most complete enterprise-wide solution available from discovery through clinical trials.

Our PK/PD Toolkit provides ready to use code (PowerBlocks) for easy drag and drop model assembly, and application-specific sample models tailored to your technical requirements.

acslX is used for the following Pharmaceutical and Risk Assessment applications:

  • Classical PK, PBPK, and PD Modeling
  • Exposure and Risk Assessment
  • Toxicity Studies
  • Drug Dispersion (ADMET)
  • Dosimetry/Dose Absorption
  • Drug Portfolio Management
  • Carcinogenesis 
Software link: Software to analyse Pharmacokinetics - acslX 
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Software to analyse Pharmacokinetics - IVIVC Toolkit

The IVIVC Toolkit for Phoenix WinNonlin expands the capabilities of Phoenix WinNonlin, enabling the use of Phoenix WinNonlin for in vivo-in vitro correlations (IVIVC). The Toolkit brings enhanced deconvolution methods, numerical convolution, new plotting capability, and the IVIVC Wizard" to pharmacokineticists and formulators. Now you can use Phoenix WinNonlin to speed formulation development

Details

improve chances of success in bioequivalence studies 
 
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Softwares in Pharmacology - CalcuSyn Version 2.0

CalcuSyn Version 2.0 is the definitive analyzer of combined drug effects, able automatically to quantify phenomena such as synergism and inhibition. Mixed drug treatment is becoming common in the treatment of cancer, AIDS etc, and CalcuSyn is the most widely used software for establishing efficacy in this field. It performs multiple drug dose-effect calculations using the Median Effect methods described by T-C Chou and P. Talalay (Trends Pharmacol. Sci. 4, 450-454).

CalcuSyn can easily be integrated with other software. Data can be entered via the keyboard or file import either into the grid or directly into the analysis engine. When the grid is used, data can be processed through wizards which make the software easily accessible to new users.

Data can be processed both for individual drugs and for constant-ratio or non-constant-ratio combinations of drugs. CalcuSyn automatically graphs the data and produces reports giving summary statistics on all drugs plus detailed analysis of drug interactions including the Combination Index and EDx (for any value of x). Estimates of accuracy of EDx and CI can be calculated with Monte Carlo simulations or by a highly accurate algebraic estimation algorithm. The plots drawn by CalcuSyn include dose-effect, median-effect, isobolograms and CI-effect. All data and results are easily accessible by mouse-click on the contents tree.

CalcuSyn Version 2.0 has Undo and Redo tools. There are flexible arrangements for printing of results and graphs and their export to spreadsheets, wordprocessors, graphics packages etc. A comprehensive manual is supplied as .pdf with the software and there is a detailed Help file. These give a thorough account of the theoretical basis of the analysis methods including the statistical treatment of results. Already used in hundreds of academic labs and pharmaceutical companies, CalcuSyn is indispensable for the study of drug mixtures.
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Softwares in Pharmacology - PHARM/PCS Version 4.2

PHARM/PCS Version 4.2, a Pharmacologic Calculation System, provides more than 45 of the computational and statistical procedures most often used to evaluate drug action and safety in experiments on animals and humans. Included are quantitative procedures for the most important pharmacologic calculations -- graded and quantal dose-response relations, relative potency, drug antagonism, Scatchard analysis, Litchfield-Wilcoxon analysis, pharmacokinetics, statistical routines, and much more.

Software Link : Softwares in Pharmacology - PHARM/PCS Version 4.2 
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Softwares in Pharmacology - Phoenix Connect's

Phoenix® Connect™ - Linking PKS™ and Third-Party Modeling and Simulation Tools with Phoenix
Phoenix Connect increases the value of common PK/PD modeling tools by removing barriers between them. Phoenix Connect allows users to save all the work done with different tools under a single Phoenix project file that can be shared, rerun, changed, and even saved as part of a workflow template that can be reused later with other datasets. With Phoenix Connect, you get all of the features of the Phoenix platform in a stand-alone application.

Phoenix Connect is a new application containing the functionality previously part of WinNonlin® Enterprise Edition and the PKS™ Client. The Enterprise edition of WinNonlin contained connectivity to various external applications and the PKS Client provided WinNonlin the ability to access PKS. Now those two sets of functionality and much more are contained in Phoenix Connect as single standalone application that can operate independently of, or in concert with, Phoenix WinNonlin.

Phoenix Connect's flexibility creates new options for you that before were too time-consuming or expensive to justify the cost. It opens up new possibilities and will enhance your productivity, freeing up time previously spent manipulating tools connecting disparate data to focus on impactful analyses and science.

Phoenix Connect can help you bridge the gaps that lie between the silos and systems that you depend on by creating connections between many common drug development software systems and protocols, such as:

Pharsight® Knowledgebase Server™ (PKS™)
Phoenix® WinNonlin®
SAS® 8 & 9
S-PLUS® 8
R® 2.9.1
NONMEM® 5 & 6
SigmaPlot® 9.0.1, 10, 11.1
ODBC data sources
Microsoft® Word™ & Excel® 2000, XP, 2003, 2007

Phoenix Connect does more than just make connections between other software systems. It puts a host of useful productivity tools at the PK/PD scientists' fingertips

Software Link : Softwares in Pharmacology - Phoenix Connect's 
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Softwares in Pharmacology - PharmTools Pro Version 1.1

PharmTools Pro Version 1.1, a welcome upgrade for users of PHARM/PCS, is based on Drug Synergism and Dose-Effect Data Analysis which focuses on drug combinations and all the quantitative analysis needed to analyze combination drug data and to design experiments with two or more compounds.

Details

PharmTools Pro Version 1.1, a welcome upgrade for users of PHARM/PCS, is based on Drug Synergism and Dose-Effect Data Analysis which focuses on drug combinations and all the quantitative analysis needed to analyze combination drug data and to design experiments with two or more compounds. 
 
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Software to analyse Pharmacokinetics - WinNonlin® AutoPilot™

WinNonlin® AutoPilot™ - Streamlining Routine Clinical PK Analyses and Reporting

WinNonlin AutoPilot is a configurable software application for WinNonlin® that automates the creation of presentation-quality clinical pharmacokinetic (PK) analysis outputs from study data to be used in standard reports. Using WinNonlin AutoPilot, companies can vastly improve their productivity while improving the quality and consistency of analyses and reports.

WinNonlin AutoPilot operates with Pharsight's enterprise PK data management system, Pharsight Knowledgebase Server™ (PKS™), and can also be used independently of PKS.

AutoPilot orchestrates PK analyses by selecting input data from a local file system or PKS, and then directs WinNonlin to perform analyses and produce report-quality tables, figures, and text output (e.g., in SigmaPlot®, Microsoft® Word and Excel®) for regulatory submissions and interim reports. AutoPilot supports all relevant study types (crossover and parallel study designs) and works with wide and stacked datasets.

AutoPilot provides the infrastructure and tools to manage and effectively automate common or repetitive data transformations, PK analysis, and creation of report-ready tables and graphs. Because these outputs must reflect the requirements and SOPs of each research organization, AutoPilot provides an administration module that allows extensive configuration of formatting and business rules that apply in the generation of these analyses. The resulting customer-defined configurations do not require changes to the underlying computer code, and are stored in a settings file that enables clear communication of standards and immediate use across the organization.

Used in conjunction with the PKS and PKS Reporter™, WinNonlin AutoPilot provides standardized, regulatory-compliant, secure and automatic generation of routine analyses and reports. AutoPilot-generated output saved to the PKS can populate standardized report templates in PKS Reporter, enabling automatic report updates and secure review and approval with electronic signatures.

Used independently of PKS, WinNonlin AutoPilot can provide significant return on investment through productivity and quality improvements in PK analysis and reporting. (see "Releasing the Human Spirit in Developing Drugs" for a case study of how a top-ten pharmaceutical company increased clinical PK productivity using automation).

Benefits
Capture and implement best practices and business rules within a department and across sites.
Standardize content and formatting of analyses and reports to reduce authoring/review effort and improve consistency and quality.
Automate analyses with computer-based scripts to ensure repeatability and traceability.
Decrease reporting backlog and submission delays, and increase ability to respond to requests for interim analyses.
Free-up PK scientific resources to focus on trial simulation, population PK modeling and model-based drug profile exploration.
Extend PK automation gains to regulatory-compliant workflows and report generation through integration with PKS and PKS Reporter.

Software Link : Software to analyse Pharmacokinetics - WinNonlin® AutoPilot™
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Softwares in Pharmacology - Pharsight Knowledgebase Server

Pharsight® Knowledgebase Server™ (PKS™) - PK Data Management

Pharsight® Knowledgebase Server™ (PKS™) provides the technical infrastructure to effectively and securely manage your pharmacokinetic / pharmacodynamic data and associated analyses across development programs or indications. With PKS, your knowledge relating to both existing drugs and new compounds is captured, stored, managed, analyzed, summarized and reported upon in a secure, regulatory-compliant environment.

PKS provides protected, structured storage, access and change tracking for your data, analyses and related files. PKS is directly integrated with Phoenix™ WinNonlin® and Phoenix™ NLME™ Pharsight?s industry-leading modeling and analysis tools, for state-of-the-art modeling and analyses. Through the PKS plug-in that is included in the Phoenix™ Connect™ product, PKS also integrates 3rd party tools such as SAS®, NONMEM®, S-PLUS® R, and SigmaPlot® and supports a seamless workflow between WinNonlin and these tools. PKS can save file formats of any type (ASCII, JPG, DOC, etc.), to capture content from a wide variety of visualization and analysis tools.

Using Phoenix Connect, Phoenix WinNonlin, Phoenix NLME , or a Web browser, your scientists access data stored in PKS studies, then use Phoenix workflows that include WinNonlin or supported 3rd party analysis tools to create and store analysis scenarios that capture models, analysis settings and results. Output is linked to the underlying study data; changes to the data tag related output for update. Each change is tracked in an audit trail, with electronic signature information including the date, user and reason for change. PKS improves traceability and management of data, analysis settings, output and reports, reducing file management overhead and enhancing data usage across your development effort.

Of course, PKS works seamlessly with Pharsight's PK Automation tool AutoPilot™ Toolkit for Phoenix® to provide a configurable software solution for standardized, regulatory-compliant, secure routine analyses and automatic generation of PK output (tables and figures) for final and intermediate reports and presentations.

Pharsight Deployment Services
Pharsight Deployment Services optimizes the configuration and installation of Pharsight PK/PD data management solutions, including AutoPilot and PKS Reporter, to fit your business needs and environment. Our experts in project management, PK/PD best practices, and large-scale systems implementation bring extensive experience, a proven migration methodology and end-to-end project management to help you deploy PKS.

Benefits
  • Secure, traceable, distributed access to data, analyses and reports.
  • Validated storage of data and analyses for regulatory submissions.
  • Support import (through PKS Connectors) and export of data in a variety of formats, including SDTM - the CDISC-defined standard for tabulation of study data.
  • Integration with Phoenix WinNonlin and other industry standard software.
  • Improved productivity through solutions for automation and standardized reporting. 

Software Link:  Softwares in Pharmacology - Pharsight Knowledgebase Server 
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LabLite Stability Tracker - R&D management software

LabLite Stability Tracker is designed to improve communications and accountability between researchers and chamber (sample aging) areas. This program is an ideal fit for product testing and R&D facilities that need to manage and prepare sample lots for testing.

LabLite Stability Tracker was designed with the following goals in mind:
  • Speed communication between researchers and chamber areas
  • Manage and prioritize the research and chamber interchange
  • Track accountability and adherence to process
  • Provide reports and metrics needed for continuous process improvement

LabLite Stability Tracker met these challenges with a program that provides:
  • A simple yet powerful user interface
  • Built-in filters, and sort capability
  • Configurable setup and permissions

Communications - LabLite Stability Tracker provides a communication interface between researchers and chamber areas by allowing them to share comments regarding changes in lot, study, and chamber status. The program can include email notifications.

Manage Workload - LabLite Stability Tracker can minimize keystrokes and data entry errors by accepting study criteria directly from the researchers. Chamber personnel place the lots into chambers meeting lab-defined conditions, and can transfer all associated lot, study, and chamber information without repetitive data entry. LabLite Stability Tracker allows multiple reserachers the ability to see the status of their lots and studies anywhere in the process. User rights are definable.

Tracking - LabLite Stability Tracker provides a date/time stamp of every sample status change or action. This includes tracking when lots are moved between chambers or are pulled from chambers for testing. Items can be searched by date range, researcher, study, lot, product, unit, chamber etc... combining power, flexibility, and ease of use.

Reports and Metrics - LabLite Stability Tracker maintains study, lot, and chamber information throughout the aging process. Chamber and study specific reports can be produced electronically or in hard copy. Study details can be used to establish metrics or target areas for process improvement.

Software link: LabLite Stability Tracker - R&D management software 
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UV Dissolition Software

Customized automation for best dissolution results

The new Agilent WinUV Dissolution Software generates accurate and robust data. The software supports multiple hardware configurations for sampling, filtering, and archiving your samples. Designed to run on Microsoft® Windows® XP, it provides a 21 CFR Part 11 compliant environment for your laboratory data and operations.

Features
Versatile. Agilent UV Dissolution Software operates both multicell and fiber-optic configurations so you have only one software system to learn for operating either configuration
Functionality. Delivers real-time results, reduces analysts' time and effort, and shortens decision timelines for critical projects
Variable Data Collection Rate. Specify multiple regions in the run, each with a different data collection rate
Secure Data Collection. The Agilent UV Dissolution Software stores data as it is acquired, keeping it secure, even in the event of a power outage
21 CFR Part 11 Compliance. The Spectroscopy Configuration Manager allows you to manage compliance by creating, configuring, and maintaining data in relation to system security, user management, and data paths
Comprehensive Reporting Solution. Customized for your specific needs, colorful graphics showing multiple data points can be included in a report
Multi-component Analysis Capability. Agilent partners with CAMO Software Inc. to integrate The Unscrambler®, an easy-to-use package for multi-component drug product analysis

Software URL: UV Dissolition Softwarex
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