Category: Pharmaceutical
Biotech
Industry
Pharmaceutical
The consideration of working with pharmaceutical contract service organizations
The pharmaceutical industry has witnessed a paradigm shift, with contract service organizations (CSOs) emerging as powerful contributors across the spectrum of research, development, and manufacturing. These partnerships unlock access to specialized expertise, infrastructure, and economies of scale....
Chemical
Pharmaceutical
Sci&Tech
what is drug-like properties
Drug-like properties, also known as druglikeness, are a crucial concept in the pharmaceutical world. They describe the inherent characteristics of a molecule that influence its potential for successful drug development. In 2000, Christopher A. Lipinski proposed...
Biotech
Pharmaceutical
Sci&Tech
Drug discovery: is target-based superior to phenotypic model?
In current pharmaceutical sciences, when we talk about innovative drug discovery, we should think of target-based drug discovery, which is to design synthetic drugs based on a target. Then, have we thought about how efficient this...
cGMP
Industry
Pharmaceutical
The importance of CMC in Drug Development
Drug development is a long, expensive, and risky process. The drug development process mainly includes: Target identification, Discovery, Preclinical pharmaceutical research (IND), Clinical trials (Phases I, II, and III) , NDA/BLA and comercial Launch. CMC (Chemistry Manufacturing & Control) is a very important part of drug approval....
Industry
Pharmaceutical
PopSci
Test BARD for the topic of Weight loss Drug
Recently, the weight loss drug is at the spotlight. I just want to test how Google Bard will tell me about this topic. So I got three questions and three answers. It only helps understand the...
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...
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...