A Comprehensive Software Solution for
Nonclinical Pharmacokinetics and Metabolism Studies
Bioanalysis and Management
Data Analysis and Reporting
Team Representation and Strategic Planning
Regulatory Support ( IND, NDA and MAA)
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.
Noncomparmental PK analysis
Compartmental PK Analysis
Dissolution Data Analysis
In vitro – in vivo Correlation
Plasma PK Analysis
Urine PK Analysis
BE 2x2 crossover,
Oral (1CBM, 2CBM)
Intravenous (1CBM, 2CBM, 3CBM)
Intravenous infusion (1CBM, 2CBM, 3CBM)
Sigmoidal inhibitory Emax
Multivariate statistical distance
Level A correlation
Levels A, B, C, and Levy Plots
Sample size calculation
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
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.
An IT professional with 20 years of experience in application 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.
Address: APL ANALYST IT SOLUTIONS PVT. LTD. WS365, 3rd Floor, 27 main Rd, 1st Sector, HSR Layout, Bengaluru, Karnataka, 560102, INDIA Phone: (+91) 80 4149 5681 Email: firstname.lastname@example.org
Address: APL 9671 Laforet drive, Eden Prairie, MN 55347, USA Phone:(+1) 952-294-9868 Email: email@example.com