{"title":"Jingjing Ye","description":null,"products":[{"product_id":"innovative-designs-and-analyses-for-small-population-clinical-trials-book-jingjing-ye-9783031608421","title":"Innovative Designs and Analyses for Small Population Clinical Trials","description":"This book discusses a multidisciplinary and multi-stakeholder collaborative approach to small population clinical trials. It provides and illustrates a systematic framework that depends upon a collaborative infrastructure between the patient community, patient advocacy groups, researchers and investigators, pharmaceutical companies, global regulatory agencies, and customers. The book also highlights the considerations of natural history and patient registry, diagnostic criteria determination, identification of clinically meaningful endpoints, and global regulatory guidance. The authors detail the nuances of clinical trial design as specific to small population disease, drawing from real examples.","brand":"WoB","offers":[{"title":"- \/ - \/ -","offer_id":51060404355345,"sku":"","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"US \/ NEW \/ INGRAM","offer_id":51060407140625,"sku":"NIN9783031608421","price":0.0,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/3031608429.jpg?v=1789212690"},{"product_id":"dose-finding-and-beyond-in-biopharmaceutical-development-book-jingjing-ye-9783031671098","title":"Dose Finding and Beyond in Biopharmaceutical Development","description":"\u003cp\u003eThis book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development.\u003c\/p\u003e\n\n\u003cp\u003eFinding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase Ⅱ clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be thought of as the doses between MinED and MTD. From this dose range, one or a few doses are selected for Phase Ⅲ confirmation. In practice, dose finding is a very difficult in every phase of clinical development for new drugs.\u003c\/p\u003e\n\n\u003cp\u003eThe editors brought distinguished researchers and practitioners in biopharmaceuticals and universities, to discuss the statistical procedures, useful methods, and their novel applications in dose finding. The chapters in the book present emerging topics in dose-finding and related interdisciplinary areas. This timely book is a valuable resource to stimulate the development of this growing and exciting field in drug development. \u003c\/p\u003e","brand":"WoB","offers":[{"title":"- \/ - \/ -","offer_id":51111165231377,"sku":"","price":0.0,"currency_code":"GBP","in_stock":true},{"title":"US \/ NEW \/ INGRAM","offer_id":51111167623441,"sku":"NIN9783031671098","price":0.0,"currency_code":"GBP","in_stock":false},{"title":"GB \/ NEW \/ GARDNERS","offer_id":51717910921489,"sku":"NGR9783031671098","price":0.0,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0784\/4072\/6801\/files\/3031671090.jpg?v=1785816910"}],"url":"https:\/\/www.worldofbooks.com\/en-gb\/collections\/author-books-by-jingjing-ye.oembed","provider":"World of Books ","version":"1.0","type":"link"}