Category: Pharmaceutical
Pharmaceutical
Sci&Tech
Conventional or Microtracer method in human ADME
Notes from the Journal Article: Human Absorption, Distribution, Metabolism, and Excretion Studies: Conventional or Microtracer? Sean Xiaochun Zhu, Drug Metabolism and Disposition, DOI: https://doi.org/10.1016/j.dmd.2025.100067 This article provides a detailed review of a forthcoming publication in Drug Metabolism and Disposition...
Pharmaceutical
Sci&Tech
Basics of Biomarker
What is a Biomarker? The term “biomarker” is composed of “biological” and “marker.” Different disciplines have slightly different definitions for biomarkers, but the general concept is consistent. The National Institutes of Health (NIH) in the...
Chemical
Industry
Pharmaceutical
Regulation
The Ames Test: Unraveling Mutagenic Potential
The Ames test, a cornerstone of genetic toxicology, serves as a crucial tool for identifying potential mutagens and carcinogens. Several regulatory guidelines govern the conduct and interpretation of Ames tests, including OECD Test Guideline 471: This guideline provides...
Pharmaceutical
Regulation
Sci&Tech
ADME Testing: Your Drug’s Journey
Intro Why ADME? In Vitro vs. In Vivo ADME: The Breakdown For a deep dive into the details, you can continue reading for the next 3 minutes. The journey of a drug from the lab to the pharmacy...
Biotech
Industry
Pharmaceutical
Biotech Business Model：Hub-and-Spoke
The biotechnology business model is characterized by high risk, high reward, and a long development timeline. There is an increasing trend of “hub and spoke” business models, where companies have multiple subsidiary companies, each focused on...
Industry
Pharmaceutical
What Sells Innovative Drugs
The landscape of innovative drug development is primarily shaped by First-in-Class (FIC) and Best-in-Class (BIC) molecules. FIC molecules, through their pioneering nature, define new therapeutic pathways, providing a crucial first-mover advantage. BIC molecules, on the other...
Pharmaceutical
Sci&Tech
Formulation Methods for Poorly Soluble Drugs
In the development of innovative drugs, poorly soluble candidate drugs of BCSII and BCSIV account for nearly 90%. And statistics show that about 40% of currently marketed drugs are poorly soluble compounds. Due to the poor oral absorption...
Pharmaceutical
Regulation
Sci&Tech
Implement New Approach Methodologies (NAMs) in Drug Development
The landscape of drug development is evolving, with a growing emphasis on reducing and replacing animal testing. New Approach Methodologies (NAMs) are at the forefront of this shift, offering innovative, non-animal methods to assess drug safety...
Pharmaceutical
Regulation
What are drugs made in the US
There’s no strict legal definition of “Made in USA” for drugs enforced by the FDA. However, we can still refer to some regulation requirements to help understand how they are generally categorized in relation to their origin: 1....
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...