A Comprehensive Software Solution for
Pharmacokinetics
Biopharmaceutics
Pharmacodynamics
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)
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 LLC has started its operations in Bangalore, India by forming the APL Analyst IT Solutions Pvt Ltd company in May 2018, with the vision of software services and product development. Currently APL Analyst IT Solutions has a workforce of 20-25 programmers and testers working on a permanent and contractual basis who are diligently engaged with multiple clients for software development, testing, and maintenance of a variety of projects. We have 20+ years of IT solutions experience, product development, customized software developments, web and cloud solutions, security solutions for multiple industries including the banking, automobiles, retails, telecom, and manufacturing. We specialize in data analytics and artificial intelligence.
APL has following products and services:
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
Simulation
Reporting
Validation
Plasma PK Analysis
Urine PK Analysis
Superposition Analysis
Toxicokinetics
Interspecies Scaling
BE 2x2 crossover,
Repeated BE,
Anova,
Dose proportionality
Pharmacokinetics
Oral (1CBM, 2CBM)
Intravenous (1CBM, 2CBM, 3CBM)
Intravenous infusion (1CBM, 2CBM, 3CBM)
Pharmacodynamics
Emax
Sigmoidal Emax
Inhibitory Emax
Sigmoidal inhibitory Emax
Dissolution Models
Profile Comparisons
Multivariate statistical distance
Loo-Riegelman Method
Numeric Deconvolution
Wagner-Nelson Method
Level A correlation
Convolution
Levels A, B, C, and Levy Plots
Pharmacokinetic
Pharmacodynamic
IVIVC
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
The APL PKMP software application team brings in several decades of experience in the pharma, banking, telecom, and defense industries. Their 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.
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: info@aplanalyst.com
Address: APL 9671 Laforet drive, Eden Prairie, MN 55347, USA Phone:(+1) 952-294-9868 Email: ajit.shah@aplanalyst.com
