‘DMPK services include the planning of necessary studies for regulatory filing at the appropriate time and mechanistic studies when required’
• Pharmacokinetics
– Single and Multiple Dose, Dose Proportionality, Absolute Bioavailability, PK/TK Modeling – Mass Balance/Excretion/Radiolabel Studies
– Formulation Optimization, Intestinal Permeability, other Mechanistic studies
– Bioequivalence analysis
– PK and PK/ PD analysis
– In Vitro – In Vivo Correlation (with Pharsight™ IVIVC toolkit software)
– WinNonlin™ for PK analysis and SAS for statistical analysis
• Protein Binding; RBC/Plasma Distribution Partitioning
– Protein Covalent Binding
• Tissue Distribution
– Discovery QWBA
– Quantitative Whole-Body Autoradiography (QWBA)
– Micro-autoradiography (MARG)
• Metabolism
– Metabolic Stability, Species Comparison, CYP450 Inhibition/Induction
– Metabolic Reaction Pathway Profiling
– Metabolite Profiling & Identification – In Vitro, Preclinical, and Clinical
Oncology
HIV/ TB/ Malaria/ Hepatitis and other infectious conditions
Post menopausal women
Dermatology- Transdermal patches, Gel/ Foam/ Cream, Cumulative Irritation studies & Skin sensitization studies
Hepatic Impairment
Renal Impairment (at partner Kidney Center)
Hypogonadal studies
Contraceptive studies
Cardiovascular and Metabolic Diseases- Cardiac Failure & Diabetes