Mandava Associates recognizes the importance of a Phase I program. It is critical that the preclinical and CMC development are designed to support the clinical target, whether it is registration or proof of concept. Mandava Associates excels at maximizing benefit through strategic design of early development programs.
Some of the services offered in early phase development:
Clinical studies demonstrating mechanism of action
Optimization of clinical studies based on pharmacologic studies
Cost effective development of Phase I through our network of alliances
Totally integrated approach of CMC, preclinical and clinical expertise to provide full data review with emphasis on data safety and pharmacovigilence
Clinical PK program development
Generic drug development
Mandava Associates provides comprehensive and flexible pharmacokinetic (PK) and pharmacodynamic (PD) support of Phase I/II clinical trials, and offers clinical pharmacology expertise as part of an integrated drug development program or as a discrete stand-alone service. Experience with regulatory requirements ensures that planned studies are necessary and will result in expeditious review of submissions.
Mandava Associates is skilled and experienced in the analysis and interpretation of PK/PD data, providing assessment of clinical relevance and insight into results for use in the drug development decisions. Mandava Associates provides assistance with the following PK/PD services:
ANDA bioequivalence (BE) project management
Average population and individual bioavailability (BA) and bioequivalence (BE) assessments
Compartmental and non-compartmental PK analysis and modeling
Design and analysis of PK studies, with emphasis on in vivo/in vitro correlations
Evaluation of linear and nonlinear pharmacokinetics
PK/PD modeling, useful in proving the therapeutic value of a new pharmaceutical versus similarly marketed drugs
Review of all PK parameters and concentration vs time profiles
Mandava Associates aids and provides expertise in the assessment of bioanalytical and biomarker methods and validations, conducts expert review of bioanalytical data for aberrant values requiring repeat analyses, and provides pharmacokinetic evaluation of aberrant plasma concentrations affecting study interpretation. We also perform statistical assessments of PK, PD and in vitro data, and can develop and review the PK and PD marker sections of your statistical analysis plan.