Author: ChemRealm
GLP
Pharmaceutical
Strategy for Planning IND-Enabling Safety Tests
IND-enabling safety tests are a crucial initial step in the drug development process. These tests help assess the safety profile of a new drug candidate before it can be administered to humans in clinical trials. Here’s...
Biotech
Industry
Pharmaceutical
What does BD do and how to become a BD in biotech
In the world of biotech, a Business Development (BD) professional plays a critical role in forging strategic partnerships, identifying and securing licensing deals, and driving the overall growth of the company. Here’s a breakdown of their...
Industry
What does project manager do in pharmaceutical companies
Project managers in pharmaceutical companies play a crucial role in bringing new drugs and treatments to market. Their duties encompass a wide range, overseeing the entire drug development process from conception to potential sale. Here’s a...
GLP
Pharmaceutical
Are there different GLP requirements or guidelines?
In the pharmaceutical industry, both FDA and OECD implement GLP (Good Laboratory Practice) guidelines aiming to ensure the quality and integrity of non-clinical safety studies. However, there are some key similarities and differences to consider: Similarities: Overall Goal: Both aim to...
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....