Introduction: A Nitrosamine Compliance Strategy for Biosimilars is fast becoming a required part of modern pharmaceutical quality and regulatory planning, […]
Introduction Covalently attaching functional peptide vectors to synthetic nucleic acids can substantially modify the pharmacokinetics and biodistribution of oligonucleotide therapeutics
Pharmacokinetics and Biodistribution of Peptide-Oligonucleotide Conjugate Therapeutics Read More »
Introduction: Forced Degradation Testing for Biosimilars is an important analytical strategy for understanding how a biosimilar drug substance changes when
Introduction The choice between the 505(b)(2) vs ANDA Regulatory Pathway depends largely on whether the proposed drug product is an
505(b)(2) vs ANDA: Which Regulatory Pathway Should Your Generic Drug Use? Read More »
Introduction: Dexamethasone Injection CMC requirements are a critical part of developing and submitting a generic injectable drug product through the
CMC Requirements for Dexamethasone Injection ANDA Read More »
Introduction: Silicone Lubricant Leachables are chemical substances that can migrate from silicone-lubricated components of a pharmaceutical container or drug-delivery system
Case Study: Silicone Lubricant Leachables in an Auto-Injector Primary Container Read More »
Introduction: The development of a PLGA Long-Acting Injectable Formulation for a GLP-1 receptor agonist can provide an important strategy for
Introduction Pharmaceutical sponsors can execute a Switch CDMO After ANDA Submission, but the regulatory approach depends on whether the ANDA
Can You Switch CDMOs After an ANDA Has Been Submitted to the FDA? Read More »
Introduction Analytical Method Development and Impurity Profiling for complex cyclic peptide active pharmaceutical ingredients (APIs) establishes the analytical foundation necessary
Introduction: Peptide-oligonucleotide conjugate (POC) developers face a question that shapes every downstream decision — from IND strategy to exclusivity planning:
Are Peptide-Oligonucleotide Conjugates Regulated as Small Molecules or Biologics? Read More »
