New Drug Development
An Introduction to Clinical Trials
(Hardcover)

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Updated and revised, this new edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. The latestadvancements in the realm of drug safety are discussed, and the text includes expanded coverage of clinical trials."

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.

AuthorJ. Rick Turner
BindingHardcover
EAN9781441964175
Edition2nd ed. 2010
ISBN1441964177
Height921 mm
Length614 mm
Width69 mm
Weight127 g
LanguageEnglish
Language TypePublished
Number Of Items1
Number Of Pages256
Package Quantity5
Product GroupBook
Publication Date2010-07-30
PublisherSpringer
StudioSpringer
Sales Rank141616

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General information about New Drug Development: An Introduction to Clinical Trials: Second Edition
  • The author associated with New Drug Development: An Introduction to Clinical Trials: Second Edition is J. Rick Turner.
  • The EAN for New Drug Development: An Introduction to Clinical Trials: Second Edition is 9781441964175.
  • The edition for New Drug Development: An Introduction to Clinical Trials: Second Edition is 2nd ed. 2010.
  • The ISBN for New Drug Development: An Introduction to Clinical Trials: Second Edition is 1441964177.
  • The height for New Drug Development: An Introduction to Clinical Trials: Second Edition is 921 mm.
  • The length for New Drug Development: An Introduction to Clinical Trials: Second Edition is 614 mm.
  • The width for New Drug Development: An Introduction to Clinical Trials: Second Edition is 69 mm.
  • The weight for New Drug Development: An Introduction to Clinical Trials: Second Edition is 127 g.
  • The language for New Drug Development: An Introduction to Clinical Trials: Second Edition is English.
  • The binding of New Drug Development: An Introduction to Clinical Trials: Second Edition is Hardcover.
  • The number of items for New Drug Development: An Introduction to Clinical Trials: Second Edition is 1.
  • The number of pages for New Drug Development: An Introduction to Clinical Trials: Second Edition are 256.
  • The quantity for New Drug Development: An Introduction to Clinical Trials: Second Edition in a package is 5.
  • New Drug Development: An Introduction to Clinical Trials: Second Edition is grouped in Book group of products.
  • The publication date for New Drug Development: An Introduction to Clinical Trials: Second Edition is 2010-07-30.
  • The publisher for New Drug Development: An Introduction to Clinical Trials: Second Edition is Springer.
  • The producer for New Drug Development: An Introduction to Clinical Trials: Second Edition is Springer.
  • The sales rank for New Drug Development: An Introduction to Clinical Trials: Second Edition is 141616.