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The historical development of medicines regulations
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ABPI active ADRs adverse drug reactions adverse events analysis application assessment biological cell chemical entity Clinical Development Plan Clinical Practice clinical research Clinical Research Associate clinical trials Committee compounds confidence interval cost CPMP data sheet decision disease doctor dosage dose dossier Drug Administration Drug Application drug development drug discovery economic effects efficacy enzyme enzyme inhibitors ethical European Community evaluation example expert report Food and Drug formulation guidelines human important Institutional Review Board issues leaflet Marketing Authorization measures medicinal products ment metabolism methods molecules monitoring patients pharma pharmaceutical companies pharmaceutical industry pharmaceutical physician pharmacokinetic pharmacological Phase placebo potential problems procedures programme protocol QALY quality-adjusted receptor regulations regulatory authorities relevant research and development response safety sample standard statistical target therapeutic therapy tion tissue toxicity treatment