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ICH M10 Comparison with EMA and FDA Past Guidelines on Bioanalytical Method Validation
Although the ICH has published recommendations for the validation of analytical methods used in the evaluation of the quality of drugs and active substances (ICH Q2) for more than 25 years, it was not until (...) Read more
Extractables & Leachables: Analysis, Study Design and ICH Q3E Guideline
When developing and releasing pharmaceutical products to the market, ensuring their safety and efficacy is of critical importance. Determining the impurity profile is a must, and a vital part of it is the analysis and (...) Read more
Transdermal Testing: Analysis and Quality Control of Transdermal Patches
Transdermal patches, or Transdermal Drug Delivery Systems (TDDS), are designed to deliver active substances through the skin directly into the bloodstream at a prolonged and constant rate. Due to their unique attributes, they present different (...) Read more
Stability Testing: What’s to come in 2024
Stability testing is an essential part of drug development as it ensures the efficacy and safety of the medicinal product throughout its shelf life. It allows the evaluation of APIs and drug product stability under (...) Read more
