Pradip Kokane

Overview of solid dispersion approaches to improve solubility and bioavailability, with examples and future directions; lists Pradip Kokane as the resource person.

Discussion of regulatory-accepted approaches (e.g., bootstrap f2, MSD, Mahalanobis distance) for comparing dissolution profiles when early time-point variability is high; lists Pradip Kokane as the resource person.

Explains when steady-state BE studies are required (long half-life drugs, non-linear PK, MR formulations, NTI drugs) and typical study designs; lists Pradip Kokane as the resource person.

Survey of challenges (complex generics, HVDs, NTI drugs, long half-life compounds) and modern approaches (SABE, PBPK, AI) in BE study design; lists Pradip Kokane as the resource person.

Review of polymers (e.g., PLGA, HPMC, PEG) used for controlled and targeted drug delivery and examples of PLGA applications; lists Pradip Kokane as the resource person.