Steinijans Volker (6 results)
- Hardcover
Seller: Studibuch, Stuttgart, GermanyStudibuch
Contact seller5-star sellerCondition: Used - Very good
£ 14.03
£ 53.35 shippingShips from Germany to U.S.A.Quantity: 1 available
hardcover. Condition: Gut. 336 Seiten; 9780470094754.3 Gewicht in Gramm: 1.
- Hardcover
Seller: DeckleEdge LLC, Albuquerque, NM, U.S.A.DeckleEdge LLC
Contact seller5-star sellerCondition: New
£ 77.55
Free ShippingShips within U.S.A.Quantity: 1 available
hardcover. Condition: new.
- Hardcover
- First Edition
Seller: killarneybooks, Inagh, CLARE, Irelandkillarneybooks
Contact seller5-star sellerCondition: Used - Very good
£ 56.72
£ 28.86 shippingShips from Ireland to U.S.A.Quantity: 1 available
Hardcover. Condition: 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.
- Hardcover
Seller: BennettBooksLtd, Los Angeles, CA, U.S.A.BennettBooksLtd
Contact seller5-star sellerCondition: New
£ 108.58
£ 5.09 shippingShips within U.S.A.Quantity: 1 available
Hardcover. Condition: New. In shrink wrap. Looks like an interesting title.
- Hardcover
Seller: Majestic Books, Hounslow, United KingdomMajestic Books
Contact seller4-star sellerCondition: New
£ 109.41
£ 6.50 shippingShips from United Kingdom to U.S.A.Quantity: 3 available
Condition: New. pp. 328 Illus.
- Hardcover
Seller: Revaluation Books, Exeter, United KingdomRevaluation Books
Contact seller5-star sellerCondition: New
£ 115.49
£ 12.50 shippingShips from United Kingdom to U.S.A.Quantity: 2 available
Hardcover. Condition: Brand New. 1st edition. 311 pages. 9.75x7.25x1.00 inches. In Stock.
