Blog
New Biosimilar Era | FDA’s Biggest Shift
FDA has delivered the most consequential policy change in two decades, a shift that fundamentally transforms how our industry will ...
Common Technical Document (CTD)
The Common Technical Document (CTD) is one of the most significant harmonisation achievements in global regulatory science. Before CTD, every ...
Inspection Readiness | From Audit Week to Always-On
I have lost count of how many times I have seen teams go into panic mode the week before an ...
Understanding D50 in Particle Size Distribution of API – Why It Matters!
In pharmaceutical development, Particle Size Distribution (PSD) is a critical quality attribute—especially for Active Pharmaceutical Ingredients (APIs). Among the PSD ...
API Particle Size Distribution (PSD) Matters in Generic Formulations
In generic oral solid dosage forms, API particle size distribution is not just a physical parameter—it is a critical material ...
When is a Clinical Endpoint Bioequivalence Study Required?
In the world of generic drug development, clinical endpoint bioequivalence (BE) studies come into play when traditional PK-based BE studies ...
BCS-Based Biowaiver vs. In Vivo Bioequivalence Study
When developing a generic drug for global markets, one critical decision can save months of development time and significant costs ...
Understanding Non-Sink Conditions in Dissolution Testing
In pharmaceutical R&D, dissolution testing plays a vital role in predicting drug release and bioavailability. While most studies are conducted ...
Discriminatory Dissolution & Q-Point Specification – The Connection
A dissolution method with discriminatory power ensures it can detect critical differences in formulation or process that may impact drug ...
API/Drug Substance Selection in Generic Development – Key Points
With 15 years of experience in formulation research and technology transfer, I’ve seen how critical it is to finalize the ...
Reactive Impurities in Pharmaceutical Excipients
Reactive impurities in pharmaceutical excipients are often overlooked, yet they can have a serious impact on drug product stability and ...
API Impurity Specification
In making medicines, setting impurity limits for the Active Pharmaceutical Ingredient (API) is a key step to ensure quality and ...