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Scientific guidelines (human and veterinary)

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Last updated 9 days ago

Reflection paper on higher tier testing to investigate the effects of parasiticidal veterinary medicinal products on dung fauna

9 days ago

Reflection paper on higher tier testing to investigate the effects of parasiticidal...

Reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6

9 days ago

Reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6

Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - First version

13 days ago

Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - First...

Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version

13 days ago

Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version

Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance

13 days ago

Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance

Draft ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b

about 2 months ago

Draft ICH guideline Q13 on continuous manufacturing of drug substances and drug...

ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b

about 2 months ago

ICH guideline Q13 on continuous manufacturing of drug substances and drug products...

Guideline on dossier requirements for anticancer medicinal products for dogs and cats - Revision 1

2 months ago

Guideline on dossier requirements for anticancer medicinal products for dogs and cats...

Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish - Revision 1

2 months ago

Guideline on demonstration of target animal safety and efficacy of veterinary medicinal...

Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) - Rev. 1

2 months ago

Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals)...

Draft guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1

2 months ago

Draft guideline on the summary of product characteristics for antiparasitic veterinary medicinal...