Pharmaceutical
Sci&Tech
How to solve oral absorption issues in early drug discovery
1. What is Absorption? In drug discovery, absorption is the process by which a drug transitions from its site of administration (most commonly the gastrointestinal lumen after oral dosing) into the systemic circulation. To achieve this, a dissolved drug...
Chemical
Pharmaceutical
Sci&Tech
How bench scientist select a reactionsolvent (part-1)
You look up a prep in the literature, you see the authors used DCM, so you grab the DCM bottle without a second thought. If the reaction fails, you blame the catalyst, you question the purity...
Industry
Pharmaceutical
Regulation
Navigating the Regulatory Evolution of NAMs In 2026
The pharmaceutical industry is at the threshold of a historic transformation in how medicine safety is evaluated. For decades, animal models were regarded as the “gold standard” for supporting efficacy and safety prior to human clinical...
Biotech
GLP
Pharmaceutical
Regulation
Should biomarker bioanalytical methods be validated for a non-clinical tox study
The short answear is: Yes, biomarker bioanalytical methods must be validated for animal toxicity studies, but the rigor of that validation is determined by how the data will be used to make safety or regulatory decisions. In a GLP...
Chemical
Industry
Regulation
Key notes of theOECD Guidance on Grouping of Chemicals
In the rapidly evolving landscape of product safety and drug development, the traditional “test everything” approach is becoming obsolete. Regulatory bodies, including the FDA and ECHA, are increasingly pivoting toward more efficient, humane, and scientifically...
Pharmaceutical
Regulation
The Strategic Role of Pharmacodynamic Assays in Drug Development
In the journey of drug development, we often prioritize Pharmacokinetics (PK)—understanding what the body does to the drug. However, the equally critical counterpart is Pharmacodynamics (PD): the study of what the drug does to the body. PD assays...
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...