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    PKMP
    A Comprehensive Software Solution for
    Pharmacokinetics
    Bio-pharmaceutics
    Pharmacodynamics
    Consultancy Service
    Clinical Pharmacology
    Nonclinical Pharmacokinetics and Metabolism Studies
    Bio-analysis and Management
    Data Analysis and Reporting
    Team Representation and Strategic Planning
    Scientific Publications
    Regulatory Support ( IND, NDA and MAA)

Welcome to APL

APL is pharma software solution and consulting services company supporting pharmaceutical research and development.
Our software, pharmacokinetic modeling program (PKMP) will support data analysis in the following key areas of drug development: lead identification/optimization, dose response analysis, bioequivalence analysis of products, in vitro-in vivo correlations for formulations, dissolution data analysis, modeling and predictions.

  • Provide pharmacokinetic modeling program (PKMP)
    • Pharmacokinetic, pharmacodynamic, dissolution, and in vitro-in vivo correlation data analysis
  • Provide services for
    • PK data analysis and reporting
    • Clinical pharmacology study designs and execution
    • Animal pharmacokinetic and metabolism study design and execution
    • Management of bio-analysis
    • Preparation of PK sample labeling, supplies and shipment
    • Regulatory submissions (INDs, NDAs, MAA)
    • Project team representation and strategic planning
    • In/out licensing, and
    • Scientific publications
welcome

PRODUCT-PKMP.

THE MOST COMPLETE PRODUCT EVER

Our software, pharmacokinetic modeling program (PKMP) will support data analysis for pharmacokinetic, clinical pharmacology, biopharmaceutics, and dissolution needs of new drug and generic product developments. These analyses are critical in drug development for cost and time savings.

Our consultancy services include nonclinical and clinical pharmacokinetics, biopharmaceutics, bioanalysis, and drug metabolism aspects during different phases of drug development as well as generic product development. We get involved from planning through execution and regulatory submission needs of pharmaceutical business.

Our software, pharmacokinetic modeling program (PKMP) will support data analysis in the following key areas of drug development: lead identification/optimization, dose response analysis, bioequivalence analysis of products, in vitro-in vivo correlations for formulations, dissolution data analysis, modeling and predictions.

support

PKMP Features

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PKMP Product

PKMP Software for Pharma R&D

Noncomparmental PK analysis

Compartmental PK Analysis

Dissolution Data Analysis

In vitro – in vivo Correlation

Simulation

Reporting

Validation

Noncompartmental Analysis

Plasma PK Analysis

Urine PK Analysis

Superposition Analysis

BE 2x2 crossover

Anova

Dose proportionality

Sample size calculation

Compartmental Analysis

Pharmacokinetics

Oral (1CBM, 2CBM)

Intravenous (1CBM, 2CBM, 3CBM)

Intravenous infusion (1CBM, 2CBM, 3CBM)

Pharmacodynamics

Emax

Sigmoidal Emax

Inhibitory Emax

Sigmoidal inhibitory Emax

Dissolution

Dissolution Models

Profile Comparisons

Levels A, B, C, and Levy Plots

Multivariate statistical distance

In vitro-in vivo Correlation

Wagner-Nelson Method

Loo-Riegelman Method

Numeric Deconvolution

Level A correlation

Convolution

Simulations

Pharmacokinetic

Pharmacodynamic

IVIVC

Reporting

Graphics

Tables

Export to Excel, Word, and CSV files

Validation

Validation of PKMP output for accuracy of results to user’s system

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Our Team

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Ajit Shah (Ph.D.)

Ajit Shah (Ph.D.)

Founder and president

Ajit Shah (Ph.D.)

Founder and president

More than 25 years of experience in pharmaceutical industry (Pfizer, Marion Merrel Dow, MGI Pharma Inc, and Sun Biopharma Inc.)

Expertise in drug development and regulatory submission to FDA and regulatory agencies in Europe and Japan

Expertise in developing anticancer drugs                                                                                                                                                                                                                                                           


Santosh Sonbarse (MS, MBA)

Santosh Sonbarse (MS, MBA)

Technical officer

Santosh Sonbarse (MS, MBA)

Technical officer

More than 25 years of experience in engineering and product development. Expert in software development life cycle projects, and people management.

Management experience working for several fortune 500 organizations - frontier comunications, general dynamics, target, and ADC telecom.


Darshan Sonbarse (B. Tech.)

Darshan Sonbarse (B. Tech.)

Software officer

Darshan Sonbarse (B. Tech.)

Software officer

An IT professionaal with 17 years of experience in apllication development, maintenance and performance engineering.

Experience in providing integrated solutions, application performance management and process automation across the wide range of technologies platforms and business domains.


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APL is pharma software solution and consulting services company supporting pharmaceutical research and development.


Address: 9671 Laforet drive, Eden Prairie, MN 55347 Phone:952-294-9868 Email: ajit.shah@aplanalyst.com


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