GLP

Biotech GLP Industry Pharmaceutical Regulation

Understanding about the FDA’s Embrace of New Approach Methodologies

In a landmark decision signaling a paradigm shift in pharmaceutical safety assessment, the U.S. Food and Drug Administration (FDA) announced on April 10, 2025, a plan to phase out the requirement for animal testing in the...

GLP Pharmaceutical Regulation

What non-clinical safety test are used to support drug indicated for pregnant women?

Due to ethical concerns, testing medications directly on pregnant women is strictly limited. Therefore, non-clinical safety tests play a crucial role in assessing potential risks associated with a drug for pregnant women and the developing fetus. Some...

Biotech GLP Industry Pharmaceutical

Keys for selecting preclinical drug candidate

Selecting a preclinical candidate is a critical step in drug development. It is a million dollars decision. It involves choosing the most promising drug molecule from a pool of candidates to move forward for further testing. Obviously, the...

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...

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...

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...

GLP Regulation

The synopsis of GLP

Suddenly, a though occurs in my head how to explain Good Laboratory Practice (GLP) to a beginner. Many people only need to know the key points of GLP. They do not have interests or are not...

GLP Industry

Brief Introduction to Ten GLP Principles and How are they Audited

GLP is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. While Good Laboratory Practices ( GLP ) in clinical studies...

cGMP GLP Industry Regulation

GLP VS GMP testing

For beginners to regulated pharmaceutical industry, GLP(Good Laboratory Practice) and cGMP(Current Good Manufacturing Practice) probably are the two most encountered regulatory standards. In some case, it may feel like very similar in terms of analytical testing....