Blog
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 ...
Pharmacomicrobiomics
It is the study of how intra- and inter-individual differences in the bacteria associated with us especially gut bacteria (aka ...
Lean Six Sigma and QbD
Quality by Design (QbD) is a science- and risk-based approach outlined in ICH Q8, Q9, and Q10. It emphasizes that ...
Relationship Between QTPP and CQA
Introduction In QbD) the development of a pharmaceutical product starts with understanding the patient and therapeutic needs. These needs are ...
Quality Target Product Profile (QTPP) in Pharmaceutical Development
The Quality Target Product Profile (QTPP) is a prospective summary of the key quality characteristics that a drug product should ...