Tag - Benefit-Risk Assessment

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Clinical study results: Publication

After they are published, clinical study results should be critically reviewed and assessed for such things as reliability, bias, significance, and fit with existing literature.

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Critical reading of clinical study results

When performing a critical reading of clinical study results, the reader should take relevant information into account from the best available sources and should consider questions about the reliability,...

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Information on medicinal products

Information on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.

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Principles of risk management

Risk management is important in medicines development and pharmacovigilance in order to avoid crisis situations and harmful consequences. There are various kinds of risk; risk management strategies must assess...

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