by Dr. Yashashwini Reddy | Jun 12, 2024
Once we submit the IND application, how the FDA reviews the application and what acknowledgment letter is given after the IND submission all will be discussed here. IND is an application submitted to the FDA to conduct clinical investigations in humans, once the...
by Dr. Yashashwini Reddy | Jun 10, 2024
Methods in Pharmacovigilance, this article will give you an overview of the pharmacovigilance methods and the concepts involved in it. Definition of Pharmacovigilance as per WHO: science and activities relating to detecting, assessing, understanding, and preventing...
by Dr. Yashashwini Reddy | Jun 10, 2024
Clinical trials are research studies involving human subjects to know the safety, and effectiveness of medical interventions such as drugs, medical devices, biological products, and radiological procedures. People generally volunteer to take part in these studies and...
by Dr. Yashashwini Reddy | Jun 8, 2024
A Trial Master File is a collection of documents in an organized way, and it ensures clinical trials are conducted as per good clinical practices following regulatory requirements. TMF is very important in ensuring that the trial has been managed successfully by the...
by Dr. Yashashwini Reddy | Jun 6, 2024
The Common technical document has 5 modules and is a format set by ICH for assembling the quality, safety, and efficacy information in a common format. The CTD document was introduced to streamline the dossier submission process as the earlier process was not uniform...
