Senior Scientist - Biopharmaceutics (10-14 yrs)
- Assessing the complexity of products in terms of achieving bioequivalence
- Identifying critical material attributes (CMA) of the drug substance and excipients, critical formulation components (CFC) and critical process parameters (CPP) that are expected to affect bioavailability and bioequivalence
- Identifying appropriate in-vitro characterizations tools and methodologies relevant to the in-vivo behaviour of the formulations leading to selection of appropriate formulation strategies and/or optimizing formulations to enhance success in bioequivalence studies.
- Analyzing data of bioequivalence studies with an object to identify critical parameters (CMA, CFC, CPP) that led to success or failure and suggest corrective course if required.
- Providing input to clinical pharmacology & pharmacokinetics (CPPK) team on critical aspects of the drug release that could be considered while designing bioequivalence studies.
- Development of IVIVC/IVIVR when feasible
- Performing modelling & simulations to predict in-vivo outcome based on in-vitro characteristics
- Preparing biowaiver reports for submission to regulatory agencies
- Addressing regulatory deficiencies related to dissolution and bioequivalence