Biotech
Pharmaceutical
Regulation
Brief summary of safety pharmacology studies
The assessment of safety pharmacology is primarily governed by the ICH S7A (Core Battery) and ICH S7B (Cardiovascular) guidelines. These studies are designed to investigate potential undesirable pharmacodynamic effects on vital functions before human exposure. Here is the comprehensive list...
Molecule Digest
Pharmaceutical
Sci&Tech
The Nonclinical Studies Lead to the First FDA Approved PROTAC-Veppanu
As a PROTAC (Proteolysis-Targeting Chimera), vepdegestrant represents a novel class of heterobifunctional degraders, and its non-clinical package focused heavily on its unique mechanism and potential for off-target effects. Based on the FDA approval documentation for VEPPANU...
Pharmaceutical
Regulation
Sci&Tech
VEPPANU A Breakthrough of PROTAC
The drug ARV-471, now known by its generic name vepdegestrant and brand name VEPPANU, has made history. As of May 1, 2026, it became the first-ever PROTAC (Proteolysis-Targeting Chimera) to receive FDA approval. Discovered through the pioneering work at Arvinas and detailed in...
Industry
Pharmaceutical
Regulation
Learn the keypoint in two minutes: General Considerations for the Use of New Approach Methodologies in Drug Development
The central objective of the FDA’s draft guidance is to establish a rigorous validation framework, ensuring that New Approach Methodologies (NAMs) are reliable and fit-for-purpose for specific regulatory decisions. While “qualification” evaluates a tool’s general utility, validation...
GLP
Pharmaceutical
Sci&Tech
The challenges and solutions of testing peptide drugs in Ames assay
The Ames assay (OECD 471) is the standard first step for genotoxicity screening. However, testing a peptide drug in an Ames assay is technically challenging because the assay was originally designed for small, stable, non-nutritional chemicals. When...
Pharmaceutical
Sci&Tech
The comparison of the two FDA approved aptamers
The two FDA-approved aptamer drugs, Macugen (pegaptanib) and Avacincaptad Pegol (ZIMURGA), represent two distinct generations in pharmaceutical history. Macugen, approved in 2004, was the pioneer—the first aptamer to market—but ultimately lost its dominance in the Wet AMD market to more...
Biotech
Pharmaceutical
Regulation
Top CMC Pitfalls in Biologics IND Application and How to Avoid Them
Filing an Investigational New Drug (IND) application for a biologic—be it a monoclonal antibody, recombinant protein, or vaccine—is a high-stakes milestone. While the Chemistry, Manufacturing, and Controls (CMC) section is critical, many applications face delays due...
Chemical
Instrument
PopSci
Why C18 Column is the Gold Standard of HPLC
If you’ve ever stepped into an analytical lab, you’ve likely seen a C18 column. Often called the “workhorse” of the laboratory, this single piece of technology handles nearly 80% of all high-performance liquid chromatography (HPLC) separations. I...
Chemical
Pharmaceutical
Sci&Tech
Aptamer Drug Development Status and Pipeline
The development of therapeutic aptamers has evolved from a niche technology challenged by pharmacokinetic (PK) issues (stability and renal clearance) to a robust platform. While only two RNA aptamers are currently FDA-approved, the pipeline contains dozens...
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...