Introduction: FDA and Health Canada Inspection Readiness for Testing Laboratories means maintaining a laboratory in a state where analytical activities, […]
Preparing for an FDA or Health Canada Inspection: Your Testing Lab’s Role Read More »
Introduction: Generic Drug Development for Inhaled Drug Products requires a development strategy that connects formulation science, device engineering, analytical characterization,
Introduction: Automation in Peptide-Oligonucleotide Conjugate Synthesis is becoming increasingly important as researchers seek more reproducible and scalable ways to manufacture
Automation in Peptide-Oligonucleotide Conjugate Synthesis Read More »
Introduction: PLGA Inhalable Microparticle Development combines polymer science, particle engineering, analytical characterization, and inhalation-product performance testing to create a formulation
Introduction: Nitrosamine Risk Assessment for Combination Oral Solid Dosage Forms is particularly important when a pharmaceutical product contains two or
Introduction: Hybrid LBA/LC-MS/MS Assays for Large Molecule Quantification provide a powerful analytical strategy when neither a conventional ligand-binding assay nor
Introduction: A successful Dexamethasone ANDA Submission involves far more than demonstrating that a generic product contains the same active pharmaceutical
Regulatory Pathway for Dexamethasone ANDA Submission Read More »
Introduction: Analytical Characterization of Dexamethasone Injection is one of the most important activities in developing a generic injectable drug product.
Case Study: Analytical Characterization of Dexamethasone Injection Read More »
Introduction: Extractables and Leachables Testing for Prefilled Syringes has become an essential requirement for pharmaceutical companies developing injectable biologics, biosimilars,
Introduction: Bioanalytical Method Transfer Between CROs is one of the most operationally demanding activities in clinical drug development, particularly during
