Statistical Thinking for Non-Statisticians in Drug Regulation
(Sprache: Englisch)
Focusing on the pharmaceutical non-statistician working within a very strict regulatory environment, Statistical Thinking for Clinical Trials in Drug Regulation provides the concepts and statistical thinking behind medical studies with a direct connection...
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Focusing on the pharmaceutical non-statistician working within a very strict regulatory environment, Statistical Thinking for Clinical Trials in Drug Regulation provides 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. The book provides a detailed overview of the statistical aspects of the design, conduct, analysis, and presentation of data from clinical trials within drug regulation.
Klappentext zu „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)
Inhaltsverzeichnis zu „Statistical Thinking for Non-Statisticians in Drug Regulation “
1 Basic ideas in clinical trial design2 Sampling and inferential statistics
3 Confidence intervals and p-values
4 Tests for simple treatment comparisons
5 Multi-centre trials
6 Adjusted analyses and analysis of covariance
6.3 Multiple regression
6.5.3 A single model
6.8 Connection between ANOVA and ANCOVA
7 Intention-to-treat and analysis sets
8 Power and sample size
9 Statistical significance and clinical importance
10 Multiple testing
11 Non-parametric and related methods
12 Equivalence and non-inferiority
13 The analysis of survival data
13.4.5 Calculating KM curves
13. 5 Adjusted analyses
14 Interim analysis and data monitoring committees
15 Meta-analysis
16 The role of statistics and statisticians
04705106683ENTable of contents
Introduction
Chapter 1 What are innovation, creativity and design?
Chapter 2 Innovation = creativity & commercialisation Case Study 1 BBC's 'Walking with dinosaurs'
Appendix 1 Meet the Dinosaurs
Appendix 2 Stages of the Animation Process
Appendix 3 Excerpt from Brand Guide
Appendix 4 Awards as of 30th October 2001
Chapter 3 Structured processes for developing new products
Chapter 4 A note on globalisation
Chapter 5 Innovation & branding for the web Case Study 2 ihavemoved.com - A Appendix 1 Background to the 4 founders
Chapter 6 Strategy - emergent or planned, and other issues
Chapter 7 Branding and Innovation
Chapter 8 The value of market research
Case study 3 Black & Decker's Quattro
Appendix 1 Company History
Appendix 2 Capital Appropriation Request, Summary Extracts
Chapter 9 Approaches to Market Research
Chapter 10 A note on teams
Chapter 11 Collaboration - innovation in manufacturing
Case Study 4 The Lotus Elise
Chapter 12 The role of prototypes
Chapter 13 Collaborating for innovation
Chapter 14 Innovation & industry context
Case Study 5 Roche - Saquinavir
Appendix 1 Team members
Appendix 2
... mehr
Drug Discovery Value Chain
Chapter 15 The effects of industry and cultural context
Chapter 16 Informal networks and the management of knowledge
Chapter 17 Innovation for the environment
Case Study 6 Plastwood by Dumfries Recycling
Appendix 1 Alternatives to Recycling
Appendix 2 Recycling at BPI
Chapter 18 Green design - clean environment or clean conscious?
Chapter 19 Note on Intellectual Property Rights (IPR)
Chapter 20 Innovation in large organisations
Chapter 15 The effects of industry and cultural context
Chapter 16 Informal networks and the management of knowledge
Chapter 17 Innovation for the environment
Case Study 6 Plastwood by Dumfries Recycling
Appendix 1 Alternatives to Recycling
Appendix 2 Recycling at BPI
Chapter 18 Green design - clean environment or clean conscious?
Chapter 19 Note on Intellectual Property Rights (IPR)
Chapter 20 Innovation in large organisations
... weniger
Autoren-Porträt von Richard Kay
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.
Bibliographische Angaben
- Autor: Richard Kay
- 2007, 1. Auflage., 276 Seiten, Maße: 24,4 cm, Gebunden, Englisch
- Verlag: Wiley & Sons
- ISBN-10: 0470319712
- ISBN-13: 9780470319710
Sprache:
Englisch
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