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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
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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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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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 -
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ICH Q9 Quality risk management - Scientific guideline
Last updated: 06/02/2023 -
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Clinical evaluation of new vaccines - Scientific guideline
Last updated: 01/02/2023 -
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ICH M10 on bioanalytical method validation - Scientific guideline
Last updated: 13/01/2023 -
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ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Scientific guideline
Last updated: 06/01/2023 -
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Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product-specific bioequivalence guidance
Last updated: 16/12/2022 -
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Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 16/12/2022 -
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ICH M12 on drug interaction studies - Scientific guideline
Last updated: 12/12/2022 -
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ICH E8 General considerations for clinical studies - Scientific guideline
Last updated: 02/12/2022 -
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Evaluation of medicinal products indicated for treatment of bacterial infections - Scientific guideline
Last updated: 01/12/2022 -
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ICH guideline E11A on pediatric extrapolation - Scientific guideline
Last updated: 01/12/2022 -
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Assessment of genotoxicity of herbal substances/preparations - Scientific guideline
Last updated: 31/10/2022 -
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Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells - Scientific guideline
Last updated: 26/10/2022