by Dr. Yashashwini Reddy | May 1, 2025
Standardization and Calibration of Dissolution Test Equipment is a critical aspect of pharmaceutical quality control. It ensures that drug dissolution tests are accurate, consistent, and compliant with regulatory standards such as those set by the United States...
by Dr. Yashashwini Reddy | May 1, 2025
Quality by Design (QbD) in Pharmaceuticals: A Detailed Explanation Quality by Design (QbD) is a systematic approach to pharmaceutical development that aims to ensure the quality of a drug product through the design and control of the manufacturing process. This...
by Dr. Yashashwini Reddy | Apr 28, 2025
Enhancing the stability of pharmaceutical formulations is a critical aspect of drug development and manufacturing. Stability ensures that the active ingredients in a drug maintain their potency, safety, and effectiveness throughout the product’s shelf life....
by Dr. Yashashwini Reddy | Apr 28, 2025
Resolving API Impurity Issues in Drug Development:- In pharmaceutical drug development, Active Pharmaceutical Ingredients (APIs) are the core components responsible for the therapeutic effect of a drug. However, during the manufacturing and synthesis of APIs,...
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,...
