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Clinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines.

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, conse...

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Bibliographic Details
Main Author: Brody, Tom
Format: Electronic eBook
Language:English
Published: Burlington : Elsevier Science, 2011.
Subjects:
Clinical trials > Design.
Research.
Medical care.
Medical care > Quality control.
Methodology.
Science.
Public health.
Social control.
Physical sciences.
Sociology.
Social sciences.
Drug Approval
Research
Clinical Trials as Topic
Clinical Trials Data Monitoring Committees
Research Design
Delivery of Health Care
Quality of Health Care
Health Care Quality, Access, and Evaluation
Quality Assurance, Health Care
Health Care Evaluation Mechanisms
Drug and Narcotic Control
Evaluation Studies as Topic
Professional Staff Committees
Epidemiologic Study Characteristics as Topic
Methods
Epidemiologic Methods
Investigative Techniques
Legislation, Drug
Science
Public Health
Analytical, Diagnostic and Therapeutic Techniques and Equipment
Social Control, Formal
Natural Science Disciplines
Sociology
Disciplines and Occupations
Environment and Public Health
Social Sciences
Anthropology, Education, Sociology and Social Phenomena
Patient Care
research (function)
methodology.
sciences (philosophy)
public health.
physical sciences.
sociology.
social sciences.
science (modern discipline)
Online Access: Full text (MFA users only)
ISBN:9780123919137
0123919134
Local Note:ProQuest Ebook Central
Description
Summary:Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations 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 the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understandi.
Item Description:G. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns.
Physical Description:1 online resource (673 pages)
Library Staff:View instance in FOLIO

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