ICH Q1D Guideline: Bracketing and Matrixing Designs for Stability Testing of Drug Products скачать в хорошем качестве

ICH Q1D Guideline: Bracketing and Matrixing Designs for Stability Testing of Drug Products

In this detailed presentation, we walk through the ICH Q1D Guideline, which provides scientific principles and practical guidance on applying bracketing and matrixing study designs for the stability testing of pharmaceutical drug substances and products. This approach helps reduce the testing burden while ensuring that shelf life and retest periods remain accurate and regulatory compliant. 📌 Topics Covered: Purpose of ICH Q1D Scope and application of bracketing and matrixing Full design vs. reduced design Bracketing design factors and examples Matrixing design strategies and examples Applicability, risks, and limitations Statistical considerations and data evaluation This video is ideal for: ✅ Regulatory Affairs Professionals ✅ Quality Assurance Teams ✅ Pharmaceutical Scientists ✅ Formulation and Stability Experts ✅ Pharma Manufacturing & Development Teams ✅ Students and Researchers in Pharmaceutical Sciences 📖 Reference Guidelines: ICH Q1D: Bracketing and Matrixing Designs for Stability Testing (2002) https://database.ich.org/sites/defaul... ICH Q1A(R): Stability Testing of New Drug Substances and Products 👉 Don’t forget to like, share, and subscribe for more pharmaceutical regulatory content! https://database.ich.org/sites/defaul... 🔔 For more training sessions and presentations on ICH guidelines, stability studies, and pharmaceutical regulatory affairs, stay tuned to our channel! #drugdevelopment #drugsafety #gmp #aimedical #artificialintelligence #compliance #drugproduct #fda #fdaregulations #ICHQ1D #StabilityTesting #Pharmaceuticals #RegulatoryAffairs #QualityAssurance #Bracketing #Matrixing #ICHGuidelines #PharmaceuticalDevelopment #DrugStability #GMP #ICHQ1A #DrugRegulations #ShelfLife #StabilityStudy #PharmaTraining #PharmaceuticalIndustry #QualityControl #ClinicalResearch #DrugDevelopment