عنوان

A history of a cGMP medical event investigation /

شابک

1118494881 (electronic bk.)

شابک

1118494938 (electronic bk.)

شابک

1118494946 (electronic bk.)

شابک

9781118494882 (electronic bk.)

شابک

9781118494936 (electronic bk.)

شابک

9781118494943 (electronic bk.)

شابک اشتباه

1118396618

شابک اشتباه

9781118396612

شماره

dltt

شماره ناشر

EB00063750

منبع

Recorded Books

عنوان اصلي

A history of a cGMP medical event investigation /

نام عام مواد

[Book]

نام نخستين پديدآور

Michael A. Brown.

نام خاص و کميت اثر

1 online resource

متن يادداشت

Includes bibliographical references and index

متن يادداشت

Beginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization. From initial transgenic mouse studies to the FDA fatality investigation, this case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug, including: [1] FDA Investigational and New Drug Application Processes, [2] FDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP), [3] ISPE Good Automated Manufacturing Practice (GAMP) Readers will also be introduced to a variety of managers and researchers whose personal agendas conflict with best practices and therefore compromise the safety and effectiveness of a new drug product. Throughout the case study, the author offers tested and proven practices and tips so that these human flaws are not translated into drug product flaws. These practices and tips are critical and typically can only be learned through years of experience working in competitive drug development environments. A History of a cGMP Medical Event Investigation is ideal for students in biotechnology, pharmacology, engineering, and business management as well as professionals in biomedical and drug development. All readers will discover what can go wrong in developing and bringing a new drug to market. Most importantly, they will also learn how to apply Six Sigma principles and methods to ensure safe and effective product design, development, and manufacturing

عنوان

History of a cGMP medical event investigation.

شماره استاندارد بين المللي کتاب و موسيقي

9781118396612

موضوع مستند نشده

Drugs-- Side effects.

موضوع مستند نشده

Adverse Drug Reaction Reporting Systems.

موضوع مستند نشده

Drug Therapy-- adverse effects.

موضوع مستند نشده

Investigational New Drug Application.

موضوع مستند نشده

United States.

بدون عنوان

2

موضوع مستند نشده

MED-- 012000

شماره

ويراست

شماره رده

نشانه اثر

شماره رده

مستند نام اشخاص تاييد نشده

Brown, Michael A.,1945-

مستند نام تنالگان تاييد نشده

Ohio Library and Information Network.

تاريخ عمليات

20140611152022.0

قواعد فهرست نويسي ( بخش توصيفي )

rda

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y