Venkat Shinde

December 3, 2020

Drug-Excipient Compatibility Study

What is drug-excipient compatibility? Drug-excipient compatibility study is very much important stage of formulation development of drug product in combination of excipients. It’s significant phase of […]
November 26, 2020

What is Out of-Specification Investigation and How to Proceed for it?

Background: FDA issued warning letter to the most of the drug substance and drug product manufacturer. During the inspection, FDA find out the fault, the way investigation of […]
November 21, 2020

Overview of Scale-Up and Post-Approval Changes (SUPAC)

Introduction: The development of increase in batch size from small scale to large scale is termed as scale-up. This process is required in-depth study and knowledge […]
November 17, 2020

Regulatory Requirement for Stability Study

Introduction: Pharmaceutical products shelf-life estimation by assessing through systematic stability study is regulatory requirement, during this review current regulatory requirements elaborated. The main aim of this […]