The In Vivo Pharmacology (IVP) team enables advancement of projects from discovery to the IND (Investigational New Drug) submission stage by providing critical procedural and technical expertise. The IVP team executes high-quality in-house studies and facilitates outsourcing to CROs. They specialize in designing and performing robust efficacy studies in oncology and immuno-oncology, fibrosis, and in infectious diseases. They also support pharmacokinetic modelling, PK/PD correlation and regulatory toxicology studies. The work is supported by a state-of-the-art animal vivarium at Biopolis and designated laboratory software platforms for data acquisition and analysis.
The group helps to assess drug metabolism, pharmacokinetic properties (DMPK) and animal pharmacology of the lead molecules. Once a molecule is selected for development, IND-enabling activities are conducted before regulatory submission and approval for clinical trials.
ANIMAL PHARMACOLOGY
- Develop appropriate in vivo models for testing efficacy of candidate molecules in relevant disease models; alternatively, engage selected CROs for study outsourcing
- Above studies enable profiling of candidate molecules from hit-to-lead through clinical candidate selection
DRUG METABOLISM AND PHARMACOKINETICS (DMPK)
- Determine Absorption, Distribution, Metabolism and Elimination (ADME) of compounds
- Assess plasma and target tissue concentrations of compounds in preclinical species
- Establish pharmacokinetic-pharmacodynamics (PKPD) relationships in healthy animals and disease models
- Predict efficacious exposures and PK properties in humans using allometry and Physiology Based Pharmacokinetic Profiling (PBPK)
TOXICOLOGY
- Evaluate maximum tolerated dose of test compounds in relevant preclinical species
- Evaluate CNS and CVS safety in relevant preclinical species
- Establish general toxicity in relevant species
- This information helps to determine the safe starting dose in humans and identify parameters for monitoring safety in humans