PHARMACOLOGY, TOXICOLOGY AND PHARMACEUTICAL SCIENCE
A handy one-stop reference for researchers and physicians planning and conducting global clinical trials, this book provides a practical approach to recognizing the opportunities and tackling the challenges in the planning and execution of global clinical trials for Alzheimer’s disease.
Edited by John I. Gallin and Frederick P. Ognibene
With input from experts within the NIH, the third edition of this innovative work gives clinical investigators in all fields an awareness of the tools they need to design well-conceived research protocols and meet rigorous regulatory requirements for maximizing the safety of research subjects.
Edited by Menghis Bairu and Richard Chin
This critical reference provides an up-to-date, step-by-step guidebook to build and enhance global clinical trial capacity in emerging markets and developing countries. It covers design, conduct, and the tools necessary to build and/or enhance human capacity to execute such trials, and will appeal to those managing global clinical trials in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs).
Edited by Lawrence I. Gilbert
As the perfect tool for those engaged in clinical trial design, this comprehensive guide details the organization and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from medical literature.