by Dr. Yashashwini Reddy | Aug 8, 2025
Strategies for Resolving Stability Issues in Drug Formulations Stability issues can arise due to chemical degradation, physical changes, or microbial contamination, leading to reduced efficacy, altered safety, or shortened shelf life. The resolution process involves...
by Dr. Yashashwini Reddy | Apr 19, 2025
1. What are stability studies and why are they important? Stability studies determine how the quality of a drug substance or product varies over time under the influence of environmental factors (e.g., temperature, humidity, light). They are essential for setting...
by Dr. Yashashwini Reddy | Mar 30, 2025
Module 3: Quality (CMC) in Regulatory Dossier Submission In pharmaceutical regulatory submissions, Module 3 of the Common Technical Document (CTD) plays a critical role in ensuring drug quality, safety, and efficacy. This module, also known as the Quality Module,...
by Dr. Yashashwini Reddy | Nov 26, 2024
Top Interview Questions for Experienced Candidates in Formulation R&D (Oral Solid Dosage) 1. Can you explain the pre-formulation studies conducted before developing an OSD? Answer: Pre-formulation studies involve evaluating the physicochemical properties of a drug...
by Dr. Yashashwini Reddy | Nov 21, 2024
What is Analytical Validation? Why Is It Done? Analytical validation is a vital process in the pharmaceutical industry, ensuring the methods used for drug analysis are accurate, reliable, and consistent. By validating analytical methods, pharmaceutical companies...
