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Scientific guidelines (human and veterinary)
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Last updated 11 days ago
ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b
11 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
19 days ago
Concept paper on the revision of the guideline on the Scientific Data...
Draft guideline on the quality aspects of mRNA vaccines
20 days 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
about 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
2 months ago
Implementation strategy of ICH Guideline M12 on drug interaction studies
Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance
2 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)
Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg product-specific bioequivalence guidance
3 months ago
Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg...