Statistical Thinking for Non-Statisticians in Drug Regulation

Valutazione media 3
( su 1 valutazioni fornite da Goodreads )
 
9780470319710: Statistical Thinking for Non-Statisticians in Drug Regulation

Written by a well-known lecturer and consultant to the pharmaceutical industry, this book focuses on the pharmaceutical non-statistician working within a very strict regulatory environment. Statistical Thinking for Clinical Trials in Drug Regulation presents the concepts and statistical thinking behind medical studies with a direct connection to the regulatory environment so that readers can be clear where the statistical methodology fits in with industry requirements. Pharmaceutical-related examples are used throughout to set the information in context. As a result, this book provides a detailed overview of the statistical aspects of the design, conduct, analysis and presentation of data from clinical trials within drug regulation.

Statistical Thinking for Clinical Trials in Drug Regulation:

  • Assists pharmaceutical personnel in communicating effectively with statisticians using statistical language
  • Improves the ability to read and understand statistical methodology in papers and reports and to critically appraise that methodology
  • Helps to understand the statistical aspects of the regulatory framework better quoting extensively from regulatory guidelines issued by the EMEA (European Medicines Evaluation Agency), ICH (International Committee on Harmonization and the FDA (Food and Drug Administration)

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

From the Back Cover:

Within the complex processes of planning, and conducting, analysing and reporting clinical trials in the pharmaceutical industry, the interaction between the statistician and non-statistician is not always a successful one.  There is often of confusion on the part of the non-specialist in understanding specific statistical terms and those that appear the same or similar which can make operating within a regulatory environment difficult. 

This book presents the statistical methods employed by the pharmaceutical industry in relation to current regulatory requirements and explains them in ways that are easily understandable by providing an insight into their interpretation and context in which they are used. The book does not aim to turn non-statisticians into statisticians but aims to:

  • aid communication between statisticians and non-statisticians
  • help in the critical review of reports and publications and
  • enable the more effective use of statistical arguments within the regulatory process.

Those working within the pharmaceutical industry: physicians, investigators, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in quality assurance will find this book a valuable learning tool on statistics; a key aspect of being familiar with the rules and regulations that govern their use and interpretation.

About the Author:

Richard Kay. PhD Medical Statistics. The author worked within academia until 1989 when he set up his own company offering statistics and data management services to the pharmaceutical industry.  Since 2005, he works as an Independent Statistical Consultant providing full consultancy and training course service to the Pharmaceutical and Medical Device industries. The author currently lectures and runs courses for the pharmaceutical industry in all major European countries: UK, France, Ireland, Belgium, The Netherlands, Germany, Spain, Italy, Switzerland, Sweden, Denmark, Russia and South Africa and US. His lectures are predominantly given within Pharma Cos or CROs.

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

I migliori risultati di ricerca su AbeBooks

1.

Richard Kay
Editore: Wiley-Interscience (2007)
ISBN 10: 0470319712 ISBN 13: 9780470319710
Nuovi Rilegato Quantità: 1
Da
Ergodebooks
(RICHMOND, TX, U.S.A.)
Valutazione libreria
[?]

Descrizione libro Wiley-Interscience, 2007. Hardcover. Condizione libro: New. 1. Codice libro della libreria DADAX0470319712

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 107,44
Convertire valuta

Aggiungere al carrello

Spese di spedizione: EUR 3,40
In U.S.A.
Destinazione, tempi e costi

2.

Richard Kay
Editore: Wiley-Interscience (2007)
ISBN 10: 0470319712 ISBN 13: 9780470319710
Nuovi Rilegato Quantità: 1
Da
Irish Booksellers
(Rumford, ME, U.S.A.)
Valutazione libreria
[?]

Descrizione libro Wiley-Interscience, 2007. Hardcover. Condizione libro: New. book. Codice libro della libreria 0470319712

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 119,52
Convertire valuta

Aggiungere al carrello

Spese di spedizione: GRATIS
In U.S.A.
Destinazione, tempi e costi

3.

Kay, Richard
Editore: Wiley-Interscience (2007)
ISBN 10: 0470319712 ISBN 13: 9780470319710
Nuovi Rilegato Quantità: 2
Da
Murray Media
(North Miami Beach, FL, U.S.A.)
Valutazione libreria
[?]

Descrizione libro Wiley-Interscience, 2007. Hardcover. Condizione libro: New. Codice libro della libreria P110470319712

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 124,63
Convertire valuta

Aggiungere al carrello

Spese di spedizione: EUR 2,55
In U.S.A.
Destinazione, tempi e costi

4.

Richard Kay
Editore: Wiley-Interscience 2007-10-15 (2007)
ISBN 10: 0470319712 ISBN 13: 9780470319710
Nuovi Rilegato Quantità: 1
Da
Lost Books
(AUSTIN, TX, U.S.A.)
Valutazione libreria
[?]

Descrizione libro Wiley-Interscience 2007-10-15, 2007. Hardcover. Condizione libro: New. 1. 0470319712. Codice libro della libreria 695349

Maggiori informazioni su questa libreria | Fare una domanda alla libreria

Compra nuovo
EUR 137,41
Convertire valuta

Aggiungere al carrello

Spese di spedizione: EUR 3,40
In U.S.A.
Destinazione, tempi e costi