Pharmaceutical

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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...

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...

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....

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...