Isbn: 9781441921154 - dose finding in drug development (12 risultati)

Condizione: New. In English.

Condizione: New.

Taschenbuch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book emphasizes dose selection issues from a statistical point of view. It presentsstatisticalapplicationsinthedesignandanalysisofdose-responsestudies. The importance of this subject can be found from the International Conference on Harmonization (ICH) E4 Guidance document. Establishing the dose-response relationship is one of the most important act- ities in developing a new drug. A clinical development program for a new drug can be broadly divided into four phases - namely Phases I, II, III, and IV. Phase I clinical trials are designed to study the clinical pharmacology. Information - tained from these studies will help in designing Phase II studies. Dose-response relationshipsareusuallystudiedinPhaseII.PhaseIIIclinicaltrialsarelarge-scale, long-term studies. These studies serve to con rm ndings from Phases I and II. ResultsobtainedfromPhasesI,II,andIIIclinicaltrialswouldthenbedocumented and submitted to regulatory agencies for drug approval. In the United States, - viewers from Food and Drug Administration (FDA) review these documents and make a decision to approve or to reject this New Drug Application (NDA). If the new drug is approved, then Phase IV studies can be started. Phase IV clinical trials are also known as postmarketing studies.…

Condizione: New. pp. 264.

Paperback. Condizione: Brand New. 248 pages. 8.90x5.98x0.87 inches. In Stock.

Condizione: new. Questo è un articolo print on demand.

Condizione: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Introduces the drug development process, the design and analysis of clinical trialsPresents statistical applications in the design and analysis of dose response studiesExamines important procedural steps from a pharmaceutical industry persp.…

Paperback / softback. Condizione: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.

Taschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined. 264 pp. Englisch.…

Taschenbuch. Condizione: Neu. This item is printed on demand - Print on Demand Titel. Neuware -This book will answer questions for anyone who has ever visited the pharmacy and wondered how the dosage of their prescription is determined. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained by scientists. This book introduces the drug development process, the design and analysis of clinical trials. Important procedural steps from a pharmaceutical industry perspective are also examined. Although the book is written mainly for statisticians/biostatisticians, it also serves as a useful reference to a variety of professionals working for the pharmaceutical industry and those in a drug regulatory environment. Additionally, statistical and medical professionals in academia may find this book helpful in understanding the drug development process and practical concerns in selecting doses for a new drug.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 264 pp. Englisch.…

Condizione: New. Print on Demand pp. 264 49:B&W 6.14 x 9.21 in or 234 x 156 mm (Royal 8vo) Perfect Bound on White w/Gloss Lam.

Condizione: New. PRINT ON DEMAND pp. 264.