Real-World Evidence in Medical Product Development (1st ed. 2023)

This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases.

General

Imprint:	Springer International Publishing AG
Country of origin:	Switzerland
Release date:	May 2023
First published:	2023
Editors:	Weili He • Yixin Fang • Hongwei Wang
Dimensions:	235 x 155mm (L x W)
Pages:	417
Edition:	1st ed. 2023
ISBN-13:	978-3-03-126327-9
Categories:	Books
LSN:	3-03-126327-8
Barcode:	9783031263279

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