Benefit-Risk Assessment in Pharmaceutical Research and Develo... - 9780367576240

CRC Press

Benefit-Risk Assessment in Pharmaceutical Research and DevelopmentAuthor(s): Andreas Sashegyi, James Felli, Rebecca Noel\nFormat: Paperback\nPublisher: Taylor & Francis Ltd, United Kingdom\nImprint: Chapman & Hall/CRC\nISBN-13: 9780367576240, 978-0367576240\nSynopsis\nMany practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment.\n\nThe book first presents interpretations of benefit and risk in the context of a molecule moving from preclinical evaluation into its early testing in humans. It next considers benefit and risk.