Author: ChemRealm
cGMP
GLP
Regulation
The differences between GLP and GMP in one table
Both GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) are sets of regulations designed to ensure quality and safety, but they apply to different stages of a product’s life cycle。 Here’s an analogy to understand the...
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...
Chemical
PopSci
Can you really have “Pure” chemicals
Is it possible to completely purify a chemical? This is a question that many people have wondered about at some point. The answer, unfortunately, is no. It is not possible to completely purify a chemical. Why...
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...
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
Industry
The biotech company numbers by the country
First of all, this article is just a recap of the OECD statistics. If you are interested in the topic, I would recommend a nice article at Labbiotech. The OECD’s latest update on key biotech indicators highlights rising...
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....