ChemRealm

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

The foundations of a biotech startup

A biotech startup is a complex endeavor, requiring a strong foundation in science, business, and regulatory affairs.Here are the key elements: 1. A Strong Scientific Idea or Technology: Novelty: The technology should be novel and have the potential...

Industry Sci&Tech

Basic Jargon in Technology Licensing

When licensing technology from a university or partner company, several key terms (jargon))are crucial to understand. As a scientists or engineers you should familiarize yourself with these terms which typically appear in a technology transfer agreement (TTA). Below are the core...

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...