♦ BA/BE studies in male and female volunteers involving topical/ sublingual/ ODT/ Injectable etc. other drug delivery
♦ End-to-end management of Phase II, III and IV clinical trials
♦ Drug interaction studies
♦ Dose proportionality/ Dose linearity studies
♦ Proof-of-concept studies for 505(b)2 applications
♦ BA Studies on dermatological products
♦ Relative bioavailability studies
♦ Standalone service bioanalytical method development and validation technology
♦ Standalone services for biostatistics. Regulatory assistance
♦ SDTM and aDAM compliant CDISC datasets as well as .dat, .inf files
♦ Module 2.4, 2.5, 2.6 and 2.7
♦ Evaluation of drug release from topical formulations
♦ In Vitro release rate comparison testing for pre and post-changes formulations, confirm a product’s “sameness” = Establish batch-to-batch consistency
♦ In-vitro permeability studies
♦ Enteral Tube Feeding studies – Nasogastric and gastric
♦ Statistical Analysis of Model Independent Approach Using a Similarity Factor (The similarity factor f2)
♦ Statistical Analysis of Model Independent Multivariate Confidence Region Procedure using Multivariate Statistical Distance (MSD)
♦ Statistical Analysis of Bootstrapping f2 factor
♦ In Vitro Equilibrium and Kinetic studies
♦ Statistical Analysis of stability Data analysis based on FDA guidance “Q1E Evaluation of Stability Data”
♦ Statistical Analysis of In Vitro Comparative Nasogastric (NG) tube or feeding tube studies.
