Author: ChemRealm
Biotech
Industry
Pharmaceutical
What are the FDA approved drugs for Alzheimer disease
There are currently five FDA-approved drugs for the treatment of Alzheimer’s disease: Donepezil (Aricept) is a cholinesterase inhibitor that helps to increase the levels of acetylcholine in the brain. Acetylcholine is a neurotransmitter that is involved in...
Industry
Pharmaceutical
Regulation
Whether human research can be conducted without IND
It is a a simple question, but people usually forget to ask when they enter the pharmaceutical industry. Yes, human research can be conducted without an IND(investigational new drug) in certain cases. The FDA has a...
Chemical
Industry
Regulation
What permits are needed to start a Chemical research laboratory?
The permits you need to start a chemical research lab will vary depending on the size and type of lab, as well as the local regulations. However, some common permits that may be required include: Building...
Pharmaceutical
Regulation
One Minute to Learn the Gist of Investigational New Drug (IND) Application
This is a brief note of the IND application intended for peers who just started learning the IND with very little understanding. Please refer to FDA website for more detail, but it will take some time....
Industry
Pharmaceutical
Regulation
The FDA approved drugs of 2022
As the holiday is approaching, the list of approved drugs for this year can be finalized. Of the 32 drugs for 2022, there are 13 large molecules. The biological drugs keep the growing trend. Among these...
Industry
Pharmaceutical
Regulation
A glance at the current status of regulatory guidance for Bioanalysis
As the December of 2022, half year after ICH published the finalized M10 guidance, only EMA announced the adoption of ICH from Jan. 21st, 2023. FDA published notice of the finalized ICH M10. But FDA did...
Industry
Pharmaceutical
Regulation
How ICH Guideline Topics Are Named And Categorized?
If you are new to the regulatory guidance, even some peers in the regulated field for a while, it is still quite unclear what are the M10, S6, R2 means in ICH guidelines. So this article...
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....
GLP
Industry
Brief Introduction to Ten GLP Principles and How are they Audited
GLP is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. While Good Laboratory Practices ( GLP ) in clinical studies...
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...