Category: Regulation
Chemical
Pharmaceutical
Regulation
What are Nitrosamine Impurities in Drugs
Nitrosamine, formally known as N-nitrosoamine, is a class of organic molecules with the above core structure. These type of chemicals are believed carcinogenic due to their potential as alylating reagents inside cells, which will cause cancer....
Pharmaceutical
Regulation
A Quick Guide for IND Application
How many types of FDA IND application? There are multiple types of IND application. Generally, your IND will be either 1) commercial or 2) research. It depends on whether it will be used to support marketing application afterwards. There are then three...
Pharmaceutical
Regulation
A Quick Guide to FDA pre IND Meeting
What is a pre IND meeting with FDA? Pre IND meeting with FDA is an important step of IND application. An IND application is (a) sponsor(s) that submit the product’s data and information to FDA (Food...
cGMP
GLP
Industry
Regulation
GLP VS GMP testing
For beginners to regulated pharmaceutical industry, GLP(Good Laboratory Practice) and cGMP(Current Good Manufacturing Practice) probably are the two most encountered regulatory standards. In some case, it may feel like very similar in terms of analytical testing....
Industry
Regulation
FDA-Approved Radiopharmaceuticals
I am very interested in radiopharmaceuticals, so I posted several posts about it. And Recently, I am thinking about summarize the radiopharmaceutical that already approved safe and effective in treat disease. I found http://www.radiopharmaceuticals.info is a...