352 results
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Alectinib product-specific bioequivalence guidance
Last updated: 19/12/2019 -
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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: 22/11/2019 -
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Clinical investigation of medicinal products for the treatment of gout
Last updated: 14/11/2019 -
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ICH guideline E19 on optimisation of safety data collection - Step 2b
Last updated: 30/10/2019 -
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ICH M10 on bioanalytical method validation
Last updated: 30/10/2019 -
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Pharmacokinetic and clinical evaluation of modified-release dosage forms
Last updated: 29/10/2019 -
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ICH Q3C (R6) Residual solvents
Last updated: 15/10/2019 -
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Gefitinib product-specific bioequivalence guidance
Last updated: 15/10/2019 -
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Cabozantinib product-specific bioequivalence guidance
Last updated: 15/10/2019 -
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Ezetimibe product-specific bioequivalence guidance
Last updated: 15/10/2019 -
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Colchicine product-specific bioequivalence guidance
Last updated: 15/10/2019 -
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Palbociclib product-specific bioequivalence guidance
Last updated: 15/10/2019 -
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Apixaban product-specific bioequivalence guidance
Last updated: 15/10/2019 -
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Fingolimod product-specific bioequivalence guidance
Last updated: 09/08/2019 -
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Quality of medicines questions and answers: Part 1
Last updated: 05/08/2019 -
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ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
Last updated: 30/07/2019 -
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Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 15/05/2019 -
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ICH E8 General considerations for clinical studies
Last updated: 10/05/2019 -
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ICH Q3D Elemental impurities
Last updated: 29/03/2019 -
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Investigation of subgroups in confirmatory clinical trials
Last updated: 14/03/2019 -
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Sterilisation of the medicinal product, active substance, excipient and primary container
Last updated: 08/03/2019 -
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Octreotide acetate product-specific bioequivalence guidance
Last updated: 08/02/2019 -
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Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg)
Last updated: 22/01/2019 -
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Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)
Last updated: 22/01/2019 -
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ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management
Last updated: 18/01/2019