Stock Image

New Drug Development, An Introduction to Clinical Trials

J. Rick Turner

Published by Springer-Verlag Gmbh Sep 2010, 2010
ISBN 10: 1441964177 / ISBN 13: 9781441964175
New / Buch / Quantity Available: 1
From Agrios-Buch (Bergisch Gladbach, Germany)
Available From More Booksellers
View all  copies of this book
Add to basket
List Price:
Price: £ 218.26
Convert Currency
Shipping: £ 14.81
From Germany to U.S.A.
Destination, Rates & Speeds

Save for Later

About the Book

Bibliographic Details


Title: New Drug Development, An Introduction to ...

Publisher: Springer-Verlag Gmbh Sep 2010

Publication Date: 2010

Binding: Buch

Book Condition: Neu

Edition: 1st Edition

Description:

Neuware - New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug's safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected-numerical representations of biological information-are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials. 256 pp. Englisch. Bookseller Inventory # 9781441964175

About this title:

Book ratings provided by GoodReads:
3.5 avg rating
(2 ratings)

Synopsis: New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug's safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected-numerical representations of biological information-are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.

"About this title" may belong to another edition of this title.

Bookseller & Payment Information

Payment Methods

This bookseller accepts the following methods of payment:

  • American Express
  • Bank/Wire Transfer
  • Check
  • Invoice
  • MasterCard
  • PayPal
  • Visa

[Search this Seller's Books]

[List this Seller's Books]

[Ask Seller a Question]

Bookseller: Agrios-Buch
Address: Bergisch Gladbach, Germany

AbeBooks Bookseller Since: 11 January 2012
Bookseller Rating: 5-star rating

Terms of Sale:

Allgemeine Geschäftsbedingungen (abebooks.de)

der Firma Agrios Buch- und Medienversand UG e.K. ,Geschäftsführer Ludwig Meier, De-Gasperi-Str. 8, 51469 Bergisch Gladbach nachstehend als Verkäufer bezeichnet.

§ 1 Allgemeines, Begriffsbestimmungen

(1) Der Verkäufer bietet unter dem Nutzernamen Agrios Buch unter der Plattform abebooks.de insbesondere Bücher an. Die folgenden Allgemeinen Geschäftsbedingungen (AGB) gelten für die Geschäftsbeziehung zwischen dem Verkäufer und dem Kunden in ihrer zum Ze...

[More Information]

Shipping Terms:

Der Versand ins Ausland findet IMMER mit DHL statt. Auch nach Österreich verschicken wir nur mit DHL! Daher Standardversand == Luftpost!


Detailed Seller Information