‘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