Interface between Regulation and Statistics in Drug Development

Interface between Regulation and Statistics in Drug Development

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the ava......
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<P>With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. </P><B><P></P><P>Features:</P><UL></B><P><LI>Regulatory and statistical interactions throughout the drug development continuum</LI><P></P><P><LI>The critical role of the statistician in relation to the changing regulatory and healthcare landscapes </LI><P></P><P><LI>Statistical issues that commonly arise in the cours
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With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features:Regulatory and statistical interactions throughout the drug development continuumThe critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactionsTrending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors’ decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.

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Forstå samspillet mellom regulering og statistikk i legemiddelutvikling

Velkommen til en grundig utforskning av Interface between Regulation and Statistics in Drug Development, en uunnværlig ressurs for alle som jobber med legemiddelutvikling! Dette verket tar for seg det kritiske forholdet mellom regulering og statistikk, et tema som er avgjørende for suksessen til kliniske studier og observasjonsprosjekter.

Nøkkelfunksjoner i 'Interface between Regulation and Statistics'

  • Systematisk tilnærming: Boken presenterer en samlet fremstilling av samspillet mellom regulering og statistikk.
  • Praktiske eksempler: Forfatterne deler sin omfattende erfaring fra farmasøytisk industri og akademia, med konkrete eksempler som gir innsikt i typiske utfordringer.
  • Tilgjengelighet: Innholdet er tilpasset lesere med middels kunnskap om statistikk, noe som gjør det til en nyttig ressurs for både studenter og yrkesaktive.
  • Trend-spotting: Boken belyser de nyeste emnene innen legemiddelutvikling, med fokus på hvordan endrede regulatoriske landskap påvirker prosessene.

Hvorfor velge dette verket?

Enten du er statistiker, medisinsk forsker eller jobber innen regulering, gir Interface between Regulation and Statistics in Drug Development en verdifull innsikt i hvordan man kan navigere i komplekse regulatoriske rammer. Det gir deg verktøyene og kunnskapen til å bidra til utviklingen av legemidler som kan tilfredsstille uoppfylte behov hos pasienter.

Ikke gå glipp av en sjanse til å styrke din forståelse og forbedre dine ferdigheter innen legemiddelutvikling. Skaff deg ditt eksemplar i dag og ta det første steget mot å bli en ekspert på dette viktige området!

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