Statistical Issues in Drug Development 3rd Edition Stephen S. Senn

Statistical Issues in Drug Development 3rd Edition Stephen S. Senn- Ebook Instant Download/Delivery ISBN(s): 9781119238591,9781119238607,9781119238577,1119238595,1119238609,1119238579

Product details:

• ISBN 10:1119238595
• ISBN 13: 9781119238591
• Author: Stephen S. Senn

The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more.

This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines.

Table contents:

1 Introduction

2 A Brief and Superficial History of Statistics for Drug Developers

3 Design and Interpretation of Clinical Trials as Seen by a Statistician

4 Probability, Bayes, P‐values, Tests of Hypotheses and Confidence Intervals

5 The Work of the Pharmaceutical Statistician

6 Allocating Treatments to Patients in Clinical Trials

7 Baselines and Covariate Information

8 The Measurement of Treatment Effects

9 Demographic Subgroups :

10 Multiplicity

11 Intention‐to‐Treat, Missing Data and Related Matters

12 One‐Sided and Two‐Sided Tests and Other Issues to Do with Significance and P‐values

13 Determining the Sample Size

14 Multicentre Trials

15 Active Control Equivalence Studies

16 Meta‐Analysis

17 Cross‐Over Trials

18 n‐of‐1 Trials

19 Sequential and Flexible Trials

20 Dose‐Finding

21 Concerning Pharmacokinetics and Pharmacodynamics

22 Bioequivalence Studies

23 Safety Data, Harms, Drug Monitoring and Pharmaco‐Epidemiology

24 Pharmaco‐economics and Portfolio Management

25 Concerning Pharmacogenetics, Pharmacogenomics and Personalized Medicine

People also search:

current issue in pharmacy

issues in the pharmaceutical industry

multiple testing problems in pharmaceutical statistics

what are the challenges facing the pharmaceutical industry

impacting statistics about drugs