Bioequivalence Studies in Drug Development: Methods and Applications (Statistics in Practice)

Sprache: Englisch

Verlag: Wiley, 2007

0470094753 / 9780470094754

  • Erstausgabe
  • Hardcover
  • Gebraucht
Alle Details anzeigen

Anbieter: killarneybooks, Inagh, Clare, Irlandkillarneybooks

Verkäufer/-in mit 5 Sternen

Verkäufer:in bei AbeBooks seit 20. April 2017

Hardcover

Zustand: Gebraucht - Gut

EUR 64,30

EUR 33,70 Versand 
Versand von Irland nach USA

Anzahl: 1 verfügbar

In den Warenkorb
30 Tage kostenlose Rückgabe

Artikelbeschreibung des Verkäufers

Hardcover, xiv + 311 pages, NOT ex-library. Printed in Great Britain. Minor wear, great shape. Book is clean and bright with unmarked text, free of inscriptions and stamps, firmly bound. Issued without a dust jacket. -- This book provides a comprehensive guide to the planning, execution, and statistical evaluation of bioequivalence trials. It begins by establishing the foundational principles, defining bioavailability and therapeutic equivalence, and outlining the regulatory contexts in which these studies are performed for new active substances, approved products, and modified release forms. The text then details the characterization of concentration-time profiles using essential pharmacokinetic metrics for both single and multiple-dose regimens. It builds a robust statistical framework, exploring additive and multiplicative models, normal and lognormal distributions, and the core concepts of hypothesis testing, including consumer and producer risk. A significant focus is placed on the practical assessment of average bioequivalence using the standard RT/TR crossover design, with detailed coverage of analytical procedures such as analysis of variance, the two one-sided t-tests, and nonparametric alternatives. These analytical techniques are logically linked to the crucial planning stages of determining adequate statistical power and sample size, followed by guidance on the proper presentation of results for regulatory submissions. The scope expands to address more complex scenarios, including the use of Williams designs for studies involving more than two formulations, the challenges of multiplicity in dose linearity trials, and the critical analysis of pharmacokinetic interactions like drug-drug and food-drug effects. A distinguishing feature of the work is its in-depth examination of advanced concepts that go beyond simple average comparisons, thoroughly investigating population and individual bioequivalence. This section contrasts aggregate and disaggregate criteria, details the application of replicate designs, and explains moment-based and probability-based statistical procedures. The book's breadth is further demonstrated by extending the principles of equivalence assessment to clinical endpoints, covering methodologies for both parallel group and crossover designs when direct pharmacokinetic surrogates are insufficient.…

Bestandsnummer des Verkäufers 012052

Titel
Bioequivalence Studies in Drug Development: Methods and Applications (Statistics in Practice)
Autor
Dieter Hauschke; Volker Steinijans; Iris Pigeot
Verlag
Wiley
Erscheinungsjahr
2007
Zustand
Very Good
Einband
Hardcover
Sprache
Englisch
ISBN-10
0470094753
ISBN-13
9780470094754
Auflage
1st Edition

killarneybooks

Inagh, Clare, Irland

Verkäufer/-in mit 5 Sternen

Verkäufer:in bei AbeBooks seit 20. April 2017

Versandkosten von Irland nach USA

Artikel6 bis 7 Werktage3 bis 4 Werktage
Erster ArtikelEUR 33,70EUR 38,00
Die Versandzeiten werden von den Verkäuferinnen und Verkäufern festgelegt. Sie variieren je nach Versanddienstleister und Standort. Sendungen, die den Zoll passieren, können Verzögerungen unterliegen. Eventuell anfallende Abgaben oder Gebühren sind von der Käuferin bzw. dem Käufer zu tragen. Die Verkäuferin bzw. der Verkäufer kann Sie bezüglich zusätzlicher Versandkosten kontaktieren, um einen möglichen Anstieg der Versandkosten für Ihre Artikel auszugleichen.

Zahlungsarten

  • Visa
  • Mastercard
  • American Express
  • Carte Bleue
  • Apple Pay
  • Google Pay
  • Banküberweisung
  • PayPal

Shopbeschreibung

All U.S.-bound orders are now shipped with UPS for reliable delivery. Additional customs or import fees are highly unlikely; however, please note buyers remain responsible for any duties or taxes that U.S. Customs may assess. -- Killarneybooks is a family-run bookshop based in the Republic of Ireland. We take pride in accurate listings, careful packaging, and prompt service - most orders ship within 24 hours. All books listed are in stock and ready for immediate dispatch - we are not dropshippers. Inquiries always welcome.…

Spezialisierung

professional, academic, non-fiction