Category: Pharmaceutical
Industry
Pharmaceutical
How generic drug names are decided
Who is in charge? There are two main organizations are responsible for assigning generic drug names: The United States Adopted Names (USAN) Council: A collaborative effort between the U.S. Food and Drug Administration (FDA) and the American...
Pharmaceutical
PopSci
Name a drug VS Name a person
A brand drug is the precious kid of the drug company and their dedicated staff that bring the drug to patients. They will name the drug as seriously as people name their children. Naming a drug...
Biotech
Industry
Pharmaceutical
How to identify lead compounds in drug discovery
Identifying drug lead compounds, the starting point for drug development, is a crucial and multifaceted process. Here’s a breakdown of some key strategies employed in this scientific endeavor: 1. Target Identification and Validation: The journey begins...
Biotech
GLP
Industry
Pharmaceutical
Keys for selecting preclinical drug candidate
Selecting a preclinical candidate is a critical step in drug development. It is a million dollars decision. It involves choosing the most promising drug molecule from a pool of candidates to move forward for further testing. Obviously, the...
GLP
Pharmaceutical
Strategy for Planning IND-Enabling Safety Tests
IND-enabling safety tests are a crucial initial step in the drug development process. These tests help assess the safety profile of a new drug candidate before it can be administered to humans in clinical trials. Here’s...
Biotech
Industry
Pharmaceutical
What does BD do and how to become a BD in biotech
In the world of biotech, a Business Development (BD) professional plays a critical role in forging strategic partnerships, identifying and securing licensing deals, and driving the overall growth of the company. Here’s a breakdown of their...
GLP
Pharmaceutical
Are there different GLP requirements or guidelines?
In the pharmaceutical industry, both FDA and OECD implement GLP (Good Laboratory Practice) guidelines aiming to ensure the quality and integrity of non-clinical safety studies. However, there are some key similarities and differences to consider: Similarities: Overall Goal: Both aim to...
Pharmaceutical
Regulation
Comparison of FDA drug approval pathways in one table
The FDA (Food and Drug Administration) has several pathways for approving new drugs. Each track offers advantages and disadvantages depending on the urgency and data available for the medication. Here’s a breakdown of the four main...
Industry
Pharmaceutical
Regulation
Fluorine in the Spotlight – Review of the FDA’s 2023 New Drug
The FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new molecular entities (NMEs) and new therapeutic biological products in 2023, including 33 small molecule drugs. Of these 33 small molecule drugs, 11 contain at...
GLP
Pharmaceutical
Regulation
How to conduct photosafety evaluation of Drugs
Abstract: With the increasing diversity of drug forms, the number of drugs involved in photosafety evaluation has also increased, and the frequency of photosafety being mentioned and discussed has also increased. In fact, many drugs can...