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PKMP

A Comprehensive Software Solution for

Pharmacokinetics

Biopharmaceutics

Pharmacodynamics


Consultancy Services

Clinical Pharmacology

Nonclinical Pharmacokinetics and Metabolism Studies

Bioanalysis and Management

Data Analysis and Reporting

Team Representation and Strategic Planning

Scientific Publications

Regulatory Support ( IND, NDA and MAA)

Welcome to APL

APL LLC has been incorporated in early 2015 in USA. 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.

APL has following products and services:

  • Pharmacokinetic modeling program (PKMP)
    • Pharmacokinetic, pharmacodynamic, dissolution, and in vitro-in vivo correlation data analysis
  • 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
    • Scientific publications
welcome

PKMP

THE MOST COMPLETE DATA ANALYSIS TOOL

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.

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.

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

support

PKMP Features

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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

Toxicokinetics

Interspecies Scaling

BE 2x2 crossover,

Repeated BE,

Anova,

Dose proportionality

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

Multivariate statistical distance

In vitro-in vivo Correlation

Loo-Riegelman Method

Numeric Deconvolution

Wagner-Nelson Method

Level A correlation

Convolution

Levels A, B, C, and Levy Plots

Simulations

Pharmacokinetic

Pharmacodynamic

IVIVC

Sample size calculation

PKMP Modules

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Absorption, distribution, metabolism, and elimination

A relationship between the concentration and a response

The process of dissolving a drug substance from the solid state

In vitro –in vivo correlation for modified release dosage forms

Limited sampling data analysis in animal toxicity studies

Evaluating relationships based on mathematical models

A process of checking software system meets specifications

For background and how to perform different analysis

Release Notes

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Sl No. Name Version Release Date Status
1. PKMP Release Note 1.03.38 28-May-2021 View
2. PKMP Release Note 1.03.37 6-April-2021 View
More Releases...

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APL- PKMP Software Quality Statement

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The APL PKMP software application team brings in several decades of experience in the pharma, banking, telecom, and defense industries. Our primary experience includes development of software-based systems and applications that are subjected to meeting industry and government regulations. The software developer, programmers, and tester have appropriate training and experience to develop the product, PKMP software.

APL philosophy is to produce a high quality product that requires paying attention to all the stages of software development life cycle starting from requirements gathering and analysis, design documentations, implementation, code reviews, verification and validation testing, production deployment, and production support. High quality in the final product is achieved only by ensuring quality is embedded in every stage of the product development.

Our Team

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Address: APL 9671 Laforet drive, Eden Prairie, MN 55347, USA Phone:(+1) 952-294-9868 Email: ajit.shah@aplanalyst.com