Si descrivono le attività e le responsabilità dello statistico professionale nella conduzione di una prova clinica in una industria farmaceutica o in un ente di ricerca.
Referenze Bibliografiche
C. BUNCHER -
J. Y. TSAY (Eds.),
Statistics in the pharmaceutical industry,
Dekker, second edition,
1994. |
Zbl 1092.62116 L. FRIEDMAN -
C. FURBERG -
D. DEMETS,
Fundamentals of Clinical trials,
Springer, third edition,
1998. |
Zbl 1136.62072 M. GIBALDI - D. PERRIER, Pharmacokinetics, Dekker, 1982.
S. GOODMAN, Toward evidence-based medical statistics. 1: The P-value fallacy, Annals of Internal Medicine, 130(1999a), 995-1004.
S. GOODMAN, Toward evidence-based medical statistics. 2: The Bayes factor, Annals of Internal Medicine, 130(1999b), 1004-1013.
International Conferenceon Harmonization, Statistical principles for clinical trials, http://www.ifpma.org/ich5e.html (1998).
C. JENNISON -
B. TURNBULL (Eds.),
Group Sequential Methods with Applications to Clinical Trials,
CRC Press,
1999. |
MR 1710781 |
Zbl 0934.62078 S. MILLARD -
A. KRAUSE,
Applied Statistics in the Pharmaceutical Industry,
Springer,
2001. |
Zbl 0979.62087 A. RACINE-POON - J. WAKEFIELD, Statistica methods for population pharmacokinetic modelling, Statistica Methods in Medical Research, 7 (1998), 63-84.
S. SENN,
Statistical Issued in Drug Development,
Wiley,
1997. |
Zbl 1165.62086 D. SPIEGELHALTER -
L. FREEDMAN -
M. PARMAR,
Bayesian approaches to randomized trials,
Journal of the Royal Statistical Society series A,
157(
1994), 357-416. |
fulltext (doi) |
MR 1321308 |
Zbl 1001.62529 
Con il contributo del Ministero per i Beni e le Attività Culturali