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Scientific guidelines (human and veterinary)
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Latest posts
Last updated 9 days ago
Implementation strategy of ICH Guideline M12 on drug interaction studies
9 days ago
Implementation strategy of ICH Guideline M12 on drug interaction studies
Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance
10 days 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
22 days ago
Draft reflection paper on the use of information in European Union herbal...
Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml
22 days ago
Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml
Draft reflection paper on the qualification of non-mutagenic impurities
23 days ago
Draft reflection paper on the qualification of non-mutagenic impurities
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
about 1 month 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
about 1 month ago
Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg...
Draft concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use
about 1 month ago
Draft concept paper for the development of a guideline on quality aspects...
ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Step 5
2 months ago
ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use...
Guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwater
2 months ago
Guideline on assessing the environmental and human health risks of veterinary medicinal...
Concept paper on the need for revision of the addendum on weight control in children to the guideline on clinical evaluation of medicinal products used in weight control
3 months ago
Concept paper on the need for revision of the addendum on weight...
Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
3 months ago
Concept paper for the development of a guideline on the demonstration of...