Volker steinijans (6 resultados)
- Tapa dura
Librería: Studibuch, Stuttgart, AlemaniaStudibuch
Contactar con el vendedorVendedor de 5 estrellasCondición: Usado - Bueno
EUR 15,54
Envío por EUR 62,30Se envía de Alemania a Estados Unidos de AmericaCantidad disponible: 1 disponibles
hardcover. Condición: Gut. 336 Seiten; 9780470094754.3 Gewicht in Gramm: 1.
- Tapa dura
Librería: DeckleEdge LLC, Albuquerque, NM, Estados Unidos de AmericaDeckleEdge LLC
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 90,76
Gastos de envío gratisSe envía dentro de Estados Unidos de AmericaCantidad disponible: 1 disponibles
hardcover. Condición: new.
- Tapa dura
- Primera edición
Librería: killarneybooks, Inagh, CLARE, Irlandakillarneybooks
Contactar con el vendedorVendedor de 5 estrellasCondición: Usado - Bueno
EUR 64,30
Envío por EUR 33,70Se envía de Irlanda a Estados Unidos de AmericaCantidad disponible: 1 disponibles
Hardcover. Condición: Very Good. 1st Edition. 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, execut…ion, 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.
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Librería: BennettBooksLtd, Los Angeles, CA, Estados Unidos de AmericaBennettBooksLtd
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 127,13
Envío por EUR 5,96Se envía dentro de Estados Unidos de AmericaCantidad disponible: 1 disponibles
Hardcover. Condición: New. In shrink wrap. Looks like an interesting title.
- Tapa dura
Librería: Majestic Books, Hounslow, Reino UnidoMajestic Books
Contactar con el vendedorVendedor de 4 estrellasCondición: Nuevo
EUR 128,06
Envío por EUR 7,58Se envía de Reino Unido a Estados Unidos de AmericaCantidad disponible: 3 disponibles
Condición: New. pp. 328 Illus.
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Librería: Revaluation Books, Exeter, Reino UnidoRevaluation Books
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 138,76
Envío por EUR 14,58Se envía de Reino Unido a Estados Unidos de AmericaCantidad disponible: 2 disponibles
Hardcover. Condición: Brand New. 1st edition. 311 pages. 9.75x7.25x1.00 inches. In Stock.
