Regulation

Industry Pharmaceutical Regulation Sci&Tech

PBPK Modeling -The Computational Engine Driving Modern Drug Safety

The pharmaceutical industry is undergoing a paradigm shift, moving towards New Approach Methodologies (NAMs) to reduce reliance on traditional animal models. At the forefront of this shift is Physiologically Based Pharmacokinetic (PBPK) modeling, a mechanism-driven computational approach...

Biotech Industry Pharmaceutical Regulation

List of 2025 FDA New Drug Approvals

In 2025， FDA granted 44 novel drug approvals。This list summarizes the landmark novel therapeutic approvals, categorized by molecular modality and therapeutic area. Drug Name (Active Ingredient) Modality Company Indication Mechanism of Action (MoA) Key Highlights Journavx (Suzetrigine) Small Molecule Vertex...

Industry Regulation Sci&Tech

Comparative Summary of QSAR Platforms

This table provides a high-level comparison of the five key in silico tools based on their methodology, pros, cons, cost, and regulatory standing. Tool Primary Mechanism Key Advantage Key Disadvantage Regulatory Acceptance Cost/Access DEREK Nexus Rule-Based Expert System...

Chemical GLP Pharmaceutical Regulation Sci&Tech

New Approach Methodologies for Chemical Safety Assessment

Within fields like toxicology and drug development, embracing New Approach Methodologies (NAMs) is no longer optional but crucial for professionals seeking to remain at the forefront of their disciplines. Understanding and applying these innovative, human-relevant techniques...

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...

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...

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...