Bioequivalence studies in drug development: study design, bioanalytical methods and regulatory compliance
Two formulations of the same active ingredient rarely behave identically in the body, and drug development depends on...
Mass spectrometry services for small molecule drug characterization: structural analysis, metabolite identification, and CRO support
Every small-molecule drug candidate must clear two analytical hurdles before it reaches a regulatory filing: confirmed chemical identity...
Hit-to-lead in drug discovery: analytical strategies for hit validation and lead optimization
Every small-molecule program begins with a deceptively simple question: Does this compound actually bind the target, and can...
Gas chromatography-mass spectrometry (GC-MS) in drug development: pharmaceutical applications and regulatory compliance
Since the 1980s, gas chromatography has served as a stability-indicating technique for pharmaceutical products, and gas chromatography mass...
Peptide mapping for biopharmaceutical characterization: LC-MS/MS workflows, PTM analysis, and ICH Q6B compliance
Structural complexity is one of the defining challenges of biopharmaceutical development. Unlike small-molecule drugs, large protein therapeutics (monoclonal...
Host cell protein detection in biologics: LC-MS/MS strategies for HCP clearance and regulatory compliance
Every biopharmaceutical produced in a living cell system carries an unavoidable burden: the proteins expressed by the host...
ICH Q11 development and manufacture of drug substances: analytical and process strategies for robust CMC principles implementation
Drug substance development sits at the foundation of every pharmaceutical program, yet it is often where the most...
ICH Q8 guideline for pharmaceutical development: analytical strategies for quality by design in complex drug modalities
Regulatory expectations for pharmaceutical development have evolved considerably over the past two decades, from a compliance-driven and empirical...