Pharmaceutics and Drug Safety

Pre-clinical and clinical trails

Clinical trials allow drug testing for safety assessment in different population. Preclinical development referred as preclinical studies or nonclinical Studies, is a research stage carried at initial level of increasing accessibility and iterative testing and drug safety data are collected. Main goals of preclinical studies to determine the safe dose in first phase and evaluate the product safety profile. Product may include drugs, gene safety, and diagnostic tools.

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  Clinical trials on drugs used in respiratory disorders


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  Regulatory authorities and ethics committee


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  Multi centre trials and monitoring


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  Alternative trials design and models


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  Data collection and quality control


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  Bioassay and its types


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  Designing of trials: pre-clinical studies


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  Scientific Models for Pre-Clinical and Clinical Trials


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  Pre-Clinical Testing


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  Mechanism of adverse drug reactions


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  Recent clinical trials on AIDS


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  Classification of various adverse drug reactions

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  Expected and un-expected drug reactions and its reporting