729 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 M10 on bioanalytical method validation - Scientific guideline (updated)
Last updated: 13/01/2023 -
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ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Scientific guideline (updated)
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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Liposomal amphotericin B 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 -
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Bioanalytical method validation - Scientific guideline
Last updated: 25/10/2022 -
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ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals - Scientific guideline
Last updated: 10/10/2022 -
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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: 10/10/2022 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022 -
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ICH Q14 Analytical procedure development - Scientific guideline
Last updated: 24/08/2022 -
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ICH Q2(R2) Validation of analytical procedures - Scientific guideline
Last updated: 24/08/2022 -
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Boric acid and borates
Last updated: 28/07/2022 -
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Chemistry of active substances (chemistry of new active substances) - Scientific guideline
Last updated: 26/07/2022 -
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Reflection paper on the use of measurable residual disease as a clinical endpoint in multiple myeloma studies - Scientific guideline
Last updated: 12/07/2022 -
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Quality of medicines questions and answers: Part 2
Last updated: 01/07/2022 -
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Olaparib product-specific bioequivalence guidance
Last updated: 27/06/2022 -
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Ursodeoxycholic acid product-specific bioequivalence guidance
Last updated: 27/06/2022 -
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Enzalutamide product-specific bioequivalence guidance
Last updated: 27/06/2022