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

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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...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Brody, Tom
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Burlington : Elsevier Science, 2011.
Temas:
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
Recherche.
Prestation de soins.
Soins médicaux > Qualité > Contrôle.
Méthodologie.
Sciences.
Santé publique.
Contrôle social.
Sciences physiques.
Sociologie.
Sciences sociales.
Soins médicaux.
research (function)
methodology.
sciences (philosophy)
public health.
physical sciences.
sociology.
social sciences.
science (modern discipline)
MEDICAL > Drug Guides.
MEDICAL > Nursing > Pharmacology.
MEDICAL > Pharmacology.
MEDICAL > Pharmacy.
Social sciences
Social control
Public health
Physical sciences
Methodology
Medical care > Quality control
Medical care
Clinical trials > Design
Medicine.
Health & Biological Sciences.
Medical Research.
Acceso en línea:Texto completo
Descripción
Sumario: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.
Notas:G. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns.
Descripción Física:1 online resource (673 pages)
ISBN:9780123919137
0123919134

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