Introduction: Exaggerated vs Simulated Extraction E&L is one of the most frequently misunderstood topics in extractables and leachables studies. Many […]
Exaggerated vs Simulated Use Extractions: What’s the Difference? Read More »
Introduction: Peptide-oligonucleotide conjugates (POCs) require carefully controlled strategies to remain stable because they combine two sensitive components—peptides and nucleic acids.
Stability Considerations for Peptide-Oligonucleotide Conjugates Read More »
Introduction: E&L Sample Preparation Best Practices play a crucial role in ensuring reliable results in extractables and leachables testing. Even
Best Practices for Sample Preparation in E&L Testing Read More »
Introduction Forced Degradation Studies for ANDA play an important role in stability assessment and impurity control during generic drug development.
Forced Degradation Studies for ANDA: Designing Stability and Impurity Pathways Read More »
Introduction In Abbreviated New Drug Applications (ANDA), ANDA Analytical Deficiencies are one of the most common reasons for delays, Complete
Common Analytical Deficiencies in ANDA Submissions (and How to Avoid Them) Read More »
Introduction: This Unknown Impurity Identification ANDA Case Study explains how an unidentified impurity discovered during stability testing was successfully characterized
Case Study: Unknown Impurity Identification During ANDA Development Read More »
Introduction: Nitrosamine risk assessment and Nitrosamine Testing in ANDA Submissions refer to the regulatory process used to identify, measure, and
Nitrosamine Risk Assessment and Testing in ANDA Submissions: Regulatory Expectations Read More »
Introduction Impurity Identification for ANDA Submission becomes very important when unknown peaks appear during stability or release testing. If these
Introduction: Understanding the Requirements for ANDA Submission Generic Drugs is essential for any pharmaceutical company planning to enter the U.S.
What is Required for an ANDA Submission in Generic Drug Development? Read More »
Introduction ANDA Method Validation Requirements require a high level of scientific and regulatory understanding. Although ICH Q2(R2) provides a harmonized
Method Validation Requirements for ANDA: ICH Q2(R2) vs FDA Expectations Read More »
