Sita Priya Darsini YallabandiShri Vishnu College of Pharmacy · Department of Pharmaceutical Technology
Sita Priya Darsini Yallabandi
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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...
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...
Due to the lack of sound approval process for medical devices in the EU people are suffered from many side effects. Some of the case studies which reflected mainly for the transformation of medical device regulations are PIP implants, MOM hip implants, COSTAR drug-eluting stent, and pleural seal, etc. To reflect the progress over the last 20 years,...