Incorporation of a Benefit-Risk Assessment Framework Into the Clinical Overview of Marketing Authorization Applications
| Autor: | Anne M. Wolka, Christine Radawski, Kristin Bullok, JuAn Wang, Rebecca Noel, Margaret R. Warner |
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| Rok vydání: | 2018 |
| Předmět: |
Knowledge management
business.industry Public Health Environmental and Occupational Health Pharmacy Marketing authorization 030226 pharmacology & pharmacy 01 natural sciences 010104 statistics & probability 03 medical and health sciences 0302 clinical medicine Balance (accounting) Benefit risk assessment Pharmacology (medical) 0101 mathematics business Pharmacology Toxicology and Pharmaceutics (miscellaneous) |
| Zdroj: | Therapeutic innovationregulatory science. 50(1) |
| ISSN: | 2168-4804 |
| Popis: | The main responsibility of regulators and industry is to ensure the benefit-risk balance of pharmaceutical products is positive for the intended patient populations. In recent decades, regulators and industry have taken steps to systematize benefit-risk decision making related to marketing authorization applications through the use of structured benefit-risk assessment.This manuscript presents an outline for a structured benefit-risk assessment that can be incorporated into Section 2.5.6 of the Clinical Overview to provide the basis for approval of pharmaceutical products in these regulatory submissions.The structured format presents the benefits and risks of a pharmaceutical product in the context of the medical need in the disease state, the benefits and risks of available pharmacologic and nonpharmacologic therapies, and the approach for mitigating the risks of the product under review.Ultimately, such an approach that lends further support to quality decision making would be beneficial to patients who would be treated with new pharmaceutical products. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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