by Dr. Yashashwini Reddy | Jun 3, 2024
Life Cycle Management of Investigational New Drug Application: Life cycle management of IND applications involves activities that ensure compliance with the regulatory requirements and the safe & smooth running of clinical trials. The important things to consider...
by Dr. Yashashwini Reddy | Jun 3, 2024
In this article, we are going to learn about the FDA Form 483, you will be able to understand why Form 483 is given, when it is given and what are the observations that can be presented in Form 483 and timelines. Form 483 is a document used by the U.S. Food and Drug...
by Dr. Yashashwini Reddy | Jun 2, 2024
Guidelines for Tablet Friability Determination as per United States Pharmacopeia Why Friability test is Performed – In this article we are going into detail about the friability test, how it is performed as per guidelines, the number of samples to be taken for...
by Dr. Yashashwini Reddy | May 28, 2024
Departure from an approved procedure, instruction, or documented procedure is called deviation. A deviation should be properly documented and handled. A deviation can occur during the manufacturing, testing, storage, or distribution of pharmaceuticals. Deviations most...
by Dr. Yashashwini Reddy | May 24, 2024
Drug Regulatory Authorities of Different Countries Drug regulatory authorities play a vital role in enabling the safety, efficacy, and quality of medicine we take. These authorities involve in overseeing the development, testing, approval, and monitoring of drugs...
