1.

Record Nr.

UNISALENTO991001524919707536

Autore

Rosati, Domenico

Titolo

Biografia del centrosinistra, 1945-1995 / Domenico Rosati

Pubbl/distr/stampa

Palermo : Sellerio, 1996

ISBN

8838912025

Descrizione fisica

170 p. ; 19 cm.

Collana

La nuova diagonale ; 12

Disciplina

320.945

Soggetti

Italia Politica 1945-1995

Lingua di pubblicazione

Italiano

Formato

Materiale a stampa

Livello bibliografico

Monografia

2.

Record Nr.

UNINA9910861081003321

Autore

Chow Shein-Chung <1955->

Titolo

Statistics in regulatory science / / by Shein-Chung Chow

Pubbl/distr/stampa

Boca Raton : , : CRC Press, , [2018]

ISBN

1-000-71081-5

1-000-71003-3

0-429-27506-4

Edizione

[1st ed.]

Descrizione fisica

1 online resource (553 pages)

Collana

Chapman and Hall/CRC Biostatistics Series

Disciplina

615.19

Soggetti

Drugs - Testing

Clinical trials - Statistical methods

Pharmacy - Research

Research - Statistical methods

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Nota di bibliografia

Includes bibliographical references and index.



Nota di contenuto

Totality-of-the-evidence -- Hypotheses testing versus confidence interval -- Endpoint selection -- Non-inferiority margin -- Missing data -- Multiplicity -- Sample size -- Reproducible research -- Extrapolation -- Consistency evaluation -- Drug products with multiple components -- Adaptive trial design -- Selection criteria in adaptive dose finding -- Generic drugs and biosimilars -- Precision and personalized medicine -- Big data analytics -- Rare disease drug development.

Sommario/riassunto

"The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science"--