Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines 2nd Edition (2016) (PDF) Tom Brody

164

 

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines 2nd Edition (2016) (PDF) Tom Brody

Basic Information:

  • Year: 2016
  • Page Number: 896
  • File Type: PDF
  • File Size: 14.90 MB
  • Authors/ Editiors: Tom Brody

Description:

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.

Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more

Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials

User’s Review:

Dr. Tom Brody received his PhD from the University of California at Berkeley in 1980, and conducted postdoctoral research at University of Wisconsin-Madison and also at U.C. Berkeley. His 20 research publications concern the metabolism and pharmacology of folates, cloning an anti-cancer gene (XPE gene), and the structure of an antibody (natalizumab) used for treating multiple sclerosis. The author has 15 years of pharmaceutical industry experience, acquired at Schering-Plough, Cerus Corporation, and Elan Pharmaceuticals, and has contributed to FDA submissions for the indications of multiple sclerosis, melanoma, head and neck cancer, liver cancer, pancreatic cancer, and hepatitis C. At an earlier time, he wrote two editions of Clinical Trials, published by Elsevier, Inc. The author has 16 years of training and experience in the Code of Federal regulations, as it applies to pharmaceuticals and clinical trial design.

Keywords

Free Download Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines 2nd Edition PDF

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines 2nd Edition PDF Free Download

Download Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines 2nd Edition 2016 PDF Free

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines 2nd Edition 2016 PDF Free Download

Download Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines 2nd Edition PDF

 

⏳Sale-off for a limited time only👇

☝️☝️MedbooksVN is the most trusted account provider since 2016.

☝️☝️Donate $5 to help us maintain the service.

☝️☝️MedbooksVN is the most trusted account provider since 2016.

☝️☝️Donate $5 to help us maintain the service.

☝️☝️MedbooksVN is the most trusted account provider since 2016.

'"No one has ever become poor by giving" - Anne Frank

☝️☝️Donate $5 to help us maintain the service.

☝️☝️MedbooksVN is the most trusted account provider since 2016.