Statistics for Biology and Health: Dose Finding in Drug Development (2006, Hardcover)

 ( Book Product ) 

This book emphasizes dose selection issues from a statistical point of view

• Dose Finding In Drug Development available on July 08 2018 from Indigo for 303.95
  
• ISBN bar code 9780387290744 ξ1 registered July 08 2018
  
• ISBN bar code 9780387290744 ξ2 registered July 08 2018
  
• Product category is Book

• Sku # 978038729074
  

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.

^ Statistics for Biology and Health: Dose Finding in Drug Development (2006, Hardcover) ISBN 9780387290744 (revised Jul 2018)
^ Dose Finding In Drug Development Indigo. ISBN 9780387290744 (revised Jul 2018)