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Scientific guidelines (human and veterinary)
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Last updated about 9 hours ago
Draft ICH Q1 guideline on stability testing of drug substances and drug products - Step 2b
about 9 hours ago
Draft ICH Q1 guideline on stability testing of drug substances and drug...
ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b
22 days ago
ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms...
Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes
about 1 month ago
Concept paper on the revision of the guideline on the Scientific Data...
Draft guideline on the quality aspects of mRNA vaccines
about 1 month ago
Draft guideline on the quality aspects of mRNA vaccines
ICH M11 Technical Specification - Updated step 2b
about 1 month ago
ICH M11 Technical Specification - Updated step 2b
Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2
2 months ago
Draft guideline on the clinical investigation of medicinal products in the treatment...
Implementation strategy of ICH Guideline M12 on drug interaction studies
3 months ago
Implementation strategy of ICH Guideline M12 on drug interaction studies
Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance
3 months ago
Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance
Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues
3 months ago
Draft reflection paper on the use of information in European Union herbal...
Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml
3 months ago
Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml
Draft reflection paper on the qualification of non-mutagenic impurities
3 months ago
Draft reflection paper on the qualification of non-mutagenic impurities
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
3 months ago
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)