1000 results
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Product-specific bioequivalence guidance (updated)
Last updated: 28/11/2023 -
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Pirfenidone product-specific bioequivalence guidance (updated)
Last updated: 28/11/2023 -
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Metformin product-specific bioequivalence guidance (updated)
Last updated: 28/11/2023 -
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Lurasidone product-specific bioequivalence guidance (updated)
Last updated: 28/11/2023 -
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Fampridine product-specific bioequivalence guidance (updated)
Last updated: 28/11/2023 -
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Bosutinib product-specific bioequivalence guidance (updated)
Last updated: 28/11/2023 -
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Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches - Scientific guideline (updated)
Last updated: 23/11/2023 -
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Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers - Scientific guideline (updated)
Last updated: 23/11/2023 -
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Immunologicals guidelines (updated)
Last updated: 08/11/2023 -
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Scientific guidelines for veterinary medicines (updated)
Last updated: 08/11/2023 -
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Influenza vaccines - non-clinical and clinical module - Scientific guideline
Last updated: 31/10/2023 -
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DNA and host cell protein impurities, routine testing versus validation studies - Scientific guideline
Last updated: 19/10/2023 -
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Quality: non-immunologicals
Last updated: 18/10/2023 -
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Quality: specific types of products
Last updated: 18/10/2023 -
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Quality, safety and efficacy of bacteriophages as veterinary medicines - Scientific guideline
Last updated: 13/10/2023 -
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Novel therapies
Last updated: 13/10/2023 -
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Modelling and simulation: questions and answers
Last updated: 06/10/2023 -
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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
Last updated: 06/10/2023 -
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User safety of topically administered products - Scientific guideline
Last updated: 15/09/2023 -
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Clinical investigation of medicinal products in the treatment of depression - Scientific guideline
Last updated: 07/09/2023 -
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Demonstration of efficacy of ectoparasiticides - Scientific guideline
Last updated: 21/07/2023 -
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Requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats - Scientific guideline
Last updated: 21/07/2023 -
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Development, production, characterisation and specifications for monoclonal antibodies and related products - Scientific guideline
Last updated: 21/07/2023 -
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Radiopharmaceuticals - Scientific guideline
Last updated: 21/07/2023 -
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Stability testing of existing active substances and related finished products - Scientific guideline
Last updated: 21/07/2023