Поиск по всем магазинам:

a new lease of death

Michael Brown A. A History of a cGMP Medical Event Investigation a new lease of death

Michael Brown A. A H...

Case study details the right way and the wrong way to successfully dev...

Посмотреть карточку товара

Цена: 3492.34 RUR

Подробнее

Похожие товары...

Garcia Marquez G. One Hundred Years of Solitude a new lease of death

Garcia Marquez G. On...

One Hundred Years of Solitude tells the story of the rise and fall, bi...

Посмотреть карточку товара

Цена: 746 RUR

Подробнее

Похожие товары...

Fritz Allhoff Serial Killers - Philosophy for Everyone. Being and Killing a new lease of death

Fritz Allhoff Serial...

Serial Killers – Philosophy for Everyone investigates our profound int...

Посмотреть карточку товара

Цена: 1419.71 RUR

Подробнее

Похожие товары...

Stalin: Volume II: Waiting for Hitler, 1929–1941 a new lease of death

Stalin: Volume II: W...

Well before 1929, Stalin had achieved dictatorial power over the Sovie...

Посмотреть карточку товара

Цена: 1339 RUR

Подробнее

Похожие товары...

Henry Hart The Life of Robert Frost a new lease of death

Henry Hart The Life...

The Life of Robert Frost presents a unique and rich approach to the po...

Посмотреть карточку товара

Цена: 7596.9 RUR

Подробнее

Похожие товары...

Dean Kowalski A. Classic Questions and Contemporary Film. An Introduction to Philosophy a new lease of death

Dean Kowalski A. Cla...

Featuring significant revisions and updates, Classic Questions and Con...

Посмотреть карточку товара

Цена: 3795.93 RUR

Подробнее

Похожие товары...

Leigh Bale The Healing Place a new lease of death

Leigh Bale The Heali...

A Father Desperate To Save His DaughterDr. Emma Shields had to help hi...

Посмотреть карточку товара

Цена: 118.26 RUR

Подробнее

Похожие товары...

Ann Price Back Grief Dreams. How They Help Us Heal After the Death of a Loved One a new lease of death

Ann Price Back Grief...

A program for using dreams as a tool for healing loss The universal ex...

Посмотреть карточку товара

Цена: 1548.42 RUR

Подробнее

Похожие товары...

Артур Конан Дойл The New Revelation a new lease of death

Артур Конан Дойл The...

"The New Revelation" is a firsthand account of investigation into the...

Посмотреть карточку товара

Цена: 0 RUR

Подробнее

Похожие товары...

The King's Assassin a new lease of death

The King's Assassin

The rise of George Villiers from minor gentry to royal power seemed to...

Посмотреть карточку товара

Цена: 795 RUR

Подробнее

Похожие товары...

A. C. Doyle The Death Voyage a new lease of death

A. C. Doyle The Deat...

Arthur Conan Doyle was a British writer best known for his detective f...

Посмотреть карточку товара

Цена: 227 RUR

Подробнее

Похожие товары...

William Irwin The Ultimate Harry Potter and Philosophy. Hogwarts for Muggles a new lease of death

William Irwin The Ul...

A philosophical exploration of the entire seven-book Harry Potter seri...

Посмотреть карточку товара

Цена: 1225.67 RUR

Подробнее

Похожие товары...

Pre-Raphaelites a new lease of death

Pre-Raphaelites

A society of young artists and writers, the Pre-Raphaelite Brotherhood...

Посмотреть карточку товара

Цена: 575 RUR

Подробнее

Похожие товары...

Gorm Henrik Rasmussen, Bent S. Rensen Pink Moon a new lease of death

Gorm Henrik Rasmusse...

Pink Moon - A Story about Nick DrakeOriginally written in Danish in 19...

Посмотреть карточку товара

Цена: 1536 RUR

Подробнее

Похожие товары...

Caroline Anderson Best Friend to Wife and Mother? a new lease of death

Caroline Anderson Be...

Stepping out of the ‘friend' zone…Leo Zaccharelli is a gorgeous TV che...

Посмотреть карточку товара

Цена: 118.26 RUR

Подробнее

Похожие товары...

Marie Corelli A Romance of Two Worlds a new lease of death

Marie Corelli A Roma...

Contents: An artist's studio; Mysterious potion; Three visions; A...

Посмотреть карточку товара

Цена: 1135 RUR

Подробнее

Похожие товары...

Для информации:

Case study details the right way and the wrong way to successfully develop and market a new drug 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: FDA Investigational and New Drug Application Processes FDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP) 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.