Cross-Border Drug Development: One Testing Lab for Both FDA and Health Canada Submissions
Generic Drug Development CDMO Cross-Border Drug Development: One Testing Lab for Both FDA and Health Canada Submissions By Anusha Sinha […]
What Is the Difference Between a Peptide and a Small-Molecule Drug in Manufacturing?
Peptide vs Small-Molecule CMC What Is the Difference Between a Peptide and a Small-Molecule Drug in Manufacturing? By Anusha Sinha
What Is the Difference Between a Peptide and a Small-Molecule Drug in Manufacturing? Read More »
United States vs. Overseas Peptide CDMOs: Should You Reshore Your Supply Chain?
Peptide CDMO Strategy United States vs. Overseas Peptide CDMOs: Should You Reshore Your Supply Chain? By Anusha Sinha • August
United States vs. Overseas Peptide CDMOs: Should You Reshore Your Supply Chain? Read More »
Regulatory Pathway for Dexamethasone ANDA Submission
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 »
What Is the Difference Between Biosimilarity and Interchangeability for Biosimilar Products?
Introduction The primary Difference Between Biosimilarity and Interchangeability lies in regulatory designation and pharmacy-level substitution rights rather than any variation
Case Study: Extractables and Leachables (E&L) Compliance for a Dry Powder Inhaler Seeking EMA Approval
Introduction Achieving Extractables and Leachables (E&L) Compliance for a Dry Powder Inhaler intended for European Medicines Agency (EMA) approval demands
Selectivity and Specificity in Bioanalytical Method Validation: What They Mean and How to Demonstrate Them
Bioanalytical Method Validation Selectivity and Specificity in Bioanalytical Method Validation: What They Mean and How to Demonstrate Them By Anusha
Poly(lactic-co-glycolic acid)-PEG Block Copolymers: How PEGylation Changes Nanoparticle Behaviour, Stealth Properties, and Circulation Time
Introduction Poly(lactic-co-glycolic acid)-PEG Block Copolymers influence the biological fate of nanoparticles by creating a hydrophilic, sterically protective outer layer that
Peptide Drug Substance vs. Drug Product Characterization: Analytical Differences and Regulatory Requirements
Introduction The key distinction in Peptide Drug Substance vs. Drug Product Characterization is rooted in the scope of analytical evaluation.
How a Biosimilar CDMO in United States Supports Analytical Comparability and Regulatory Success
Introduction A Biosimilar CDMO in United States plays a critical role in achieving analytical comparability and regulatory acceptance by applying