Pharmaceutical

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...

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 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...

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...