987 results
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ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Scientific guideline (updated)
Last updated: 06/10/2023 -
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ICH E6 (R2) Good clinical practice - Scientific guideline (updated)
Last updated: 26/05/2023 -
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Modelling and simulation: questions and answers (updated)
Last updated: 24/05/2023 -
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ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline (updated)
Last updated: 24/05/2023 -
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Liposomal amphotericin B product-specific bioequivalence guidance (updated)
Last updated: 22/05/2023 -
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ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - Scientific guideline (updated)
Last updated: 22/05/2023 -
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Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Scientific guideline (updated)
Last updated: 04/05/2023 -
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ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products - Step 2b - Scientific guideline
Last updated: 20/04/2023 -
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Quality aspects of pharmaceutical veterinary medicines for administration via drinking water - Scientific guideline
Last updated: 31/03/2023 -
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ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Scientific guideline
Last updated: 27/03/2023 -
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Plasmid DNA vaccines for veterinary use – Scientific guideline
Last updated: 24/02/2023 -
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Quality of modified release dosage forms for veterinary use - Scientific guideline
Last updated: 20/02/2023 -
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Stability testing of existing active substances and related finished products - Scientific guideline
Last updated: 20/02/2023 -
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Declaration of storage conditions: 1. in the product information of pharmaceutical veterinary medicinal products, 2. for active substances (Annex) - Scientific guideline
Last updated: 20/02/2023 -
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Additional quality requirements for products intended for incorporation into animal feeding-stuffs (medicated premixes) - Scientific guideline
Last updated: 20/02/2023 -
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Quality aspects of single-dose veterinary spot-on products - Scientific guideline
Last updated: 20/02/2023 -
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Parametric release - Scientific guideline
Last updated: 17/02/2023 -
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Control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “Substances for Pharmaceutical Use” and general chapter “Control of Impurities in Substances for Pharmaceutical Use” - Scientific guideline
Last updated: 17/02/2023 -
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Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary - Scientific guideline
Last updated: 17/02/2023 -
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Development pharmaceutics for veterinary medicinal products - Scientific guideline
Last updated: 17/02/2023 -
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Chemistry of active substances for veterinary medicinal products - Scientific guideline
Last updated: 17/02/2023 -
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Adjuvants in vaccines for human use - Scientific guideline
Last updated: 16/02/2023 -
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ICH guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline
Last updated: 16/02/2023 -
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Need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease - Scientific guideline
Last updated: 14/02/2023 -
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Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products - Scientific guideline
Last updated: 14/02/2023