Basava Raju's scientific contributions

Publications (2)

Article
Full-text available
The goal of this study is to understand differences in regulatory requirements, bio-equivalence data, drug registration, approval process and, guidelines associated with the generic drug filing in the USA, India, and China and also provide enough information for the drug safety and efficacy in humans. Generic drugs are identical, indistinguishable...
Article
Full-text available
Post-approval changes/variations is defined as changes in of any aspect of a pharmaceutical product after approval which includes but is not limited to manufacture process changes, packaging changes, labelling changes, finished product changes, API changes, excipient changes, etc. Among all these variations, this study is focusing on the impact on...