by Dr. Yashashwini Reddy | Jul 18, 2024
What is BCS classification? According to the BCS classification system, drugs are classified based on their solubility and intestinal permeability. The full form of BCS is the Biopharmaceutics Classification System. Drugs are classified by considering their...
by Dr. Yashashwini Reddy | Jul 14, 2024
Before diving into the difference between absolute bioavailability and relative bioavailability, let us learn some basics of the bioavailability concept. Bioavailability is a critical pharmacokinetic parameter that influences the drug’s therapeutic efficacy and...
by Dr. Yashashwini Reddy | Jun 15, 2024
In this article, we are going to see the timelines and regulatory pathways for medical devices, Small molecules drugs, etc. Regulatory pathways for New Chemical entities: Small molecules drugs are chemically synthesized ones i.e. new molecules – Traditional NDA...
by Dr. Yashashwini Reddy | Jun 14, 2024
Global expedited regulatory pathways are processes crafted to speed up new drug approval and availability across different countries. These include drugs, vaccines, and medical devices. These pathways aim to bring the new drugs as fast as possible by fastening the...
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...
