دانلود کتاب آزمایشات بالینی
Clinical Trials, 2ed

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
Extensively covers the “study schema” and related features of study design
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
Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

About the Author

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 Nutritional Biochemistry, 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.

۱ Origins of Drugs
۲ Clinical Trial Design
۳ Run-In Period
۴ Inelusion/Exclusion Criteria, Stratification, and Subgroups PartI
۵ Inelusion/Exclusion Criteria, Stratification, and Subgroups Part II
۶ Blinding, Randomization, and Allocation
۷ Placebo Arm as Part of Clinical Trial Design
۸ Intent-to-Treat Analysis Versus Per Protocol Analysis
۹ Biostatistics PartI
۱۰ Biostatistics— Part II
۱۱ Introduction to Endpoints
۱۲ Oncology Endpoint— Objective Response
۱۳ Oncology Endpoints: Overall Survival and Progression-Free Survival
۱۴ Oncology Endpoints: Time to Progression
۱۵ Oncology Endpoint: Disease-Free Survival
۱۶ Oncology Endpoint: Time to Distant Metastasis
۱۷ Neoadjuvant Therapy Versus Adjuvant Therapy
۱۸ Hematological Cancers
۱۹ Biomarkers
۲۰ Endpoints for Immune Diseases
۲۱ Endpoints for Infections
۲۲ Health-Related Quality of Life Tools— Oncology
۲۳ Health-Related Quality-of-Life Tools Immune Disorders
۲۴ Health-Related Quality-of-Life Tools— Infections
۲۵ Drug Safety
۲۶ Mechanism of Action of Diseases and Drugs— PartI
۲۷ Mechanism of Action— Part II [Cancer)
۲۸ Mechanism of Action— Part III [Immune Disorders)
۲۹ Mechanisms of Action— Part IV [Infections)
۳۰ Consent Forms
۳۱ Package Inserts
۳۲ Warning Letters
۳۳ Regulatory Approval
۳۴ Patents

جهت مشاهده ویرایش ۲۰۱۷ این کتاب کلیک کنید

قیمت : 5000 تومان

لینک کوتاه : https://bookbaz.ir/?p=39305
نویسنده : Tom Brody PhD
ناشر : Academic Press; 2 edition
سال انتشار : 2016
زبان کتاب : انگلیسی
نوع فایل : PDF
تعداد صفحات : 897
(ISBN) شابک : 0128042176
قیمت کتاب درآمازون : $70.96
حجم فایل : $70.96

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جستجو در سایت

سبد خرید

دسته ها (ترتیب الفبا)

دانلود کتاب آزمایشات بالینی
Clinical Trials, 2ed

About the Author

Contents

مهم

ضمانت پرداخت امن

آمار بروزرسانی

جستجو در سایت

سبد خرید

دسته ها (ترتیب الفبا)

دانلود کتاب آزمایشات بالینی Clinical Trials, 2ed

About the Author

Contents

کتاب های مرتبط:

مهم

ضمانت پرداخت امن

آمار بروزرسانی

دانلود کتاب آزمایشات بالینی
Clinical Trials, 2ed