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Scientific guidelines (human and veterinary)
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Last updated 3 days ago
Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
3 days ago
Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) - Revision 2
11 days ago
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products...
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products - Revision 1
11 days ago
Guideline on the pharmaceutical quality of inhalation and nasal medicinal products -...
Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1
22 days ago
Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1
Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules 33.75mg/150mg and 45mg/200mg product-specific bioequivalence guidance - Revision 1
22 days ago
Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules...
Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 2
about 1 month ago
Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 2
Posaconazole oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1
about 1 month ago
Posaconazole oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1
ICH E20 guideline on adaptive designs for clinical trials - Step 2b
about 1 month ago
ICH E20 guideline on adaptive designs for clinical trials - Step 2b
Concept paper on the need for revision of note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water
about 1 month ago
Concept paper on the need for revision of note for guidance on...
Concept paper for the development of a guideline on the methodology of environmental risk assessment for ectoparasiticidal VMPs for cats and dogs
about 1 month ago
Concept paper for the development of a guideline on the methodology of...
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections
about 1 month ago
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections
about 1 month ago
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections