1.

Record Nr.

UNINA9910808405203321

Titolo

Nonclinical safety assessment : a guide to international pharmaceutical regulations / / edited by William J. Brock, Kenneth L. Hastings, Kathy M. McGown

Pubbl/distr/stampa

Chichester, West Sussex, : John Wiley & Sons, 2013

ISBN

1-118-51700-8

1-299-24266-9

1-118-51701-6

Edizione

[1st ed.]

Descrizione fisica

1 online resource (487 p.)

Altri autori (Persone)

BrockWilliam J

HastingsKenneth L

McGownKathy M

Disciplina

615.1/901

Soggetti

Drug development - International cooperation

Drugs - Toxicology - International cooperation

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

Introduction to the development of drugs / Kathy McGown -- ICH / Ken Hastings -- USFDA / Bill Brock -- Latin America : MERCOSUR countries / Cristiana Leslie Corra -- Canada / Mark T. Goldberg -- EMEA / Adam Woolley -- Africa / Fariza Feraoun -- China / Lijie Fu -- Japan / Kazuichi Nakamura -- India / K.S. Rao -- Australia / Doug Francis -- Chronic repeat dose testing / Shana Azri-Meehan -- Carcinogenicity / James Popp -- Genotoxicity / Mark Powley -- Developmental and reproductive toxicology / Robert Parker -- Juvenile testing and pediatric claim / Melissa Tassinari -- Immunotoxicology / Leigh Ann Burns Naas -- Biologics / Chris Ellis -- Vaccines / Robert House -- Phototoxicity and photocarcinogenicity / Chris Sambuco -- Degradants, impurities excipients, and metabolites / Bob Osterberg.

Sommario/riassunto

Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-



effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practi

2.

Record Nr.

UNINA9910963977003321

Autore

Desrosiers-Lauzon Godefroy

Titolo

Florida's snowbirds : spectacle, mobility, and community since 1945 / / Godefroy Desrosiers-Lauzon

Pubbl/distr/stampa

Montreal, : McGill-Queen's Univ. Press, 2011

ISBN

9780773586628

0773586628

9780773586550

0773586555

Descrizione fisica

1 online resource (377 p.)

Disciplina

975.9008696

Soggetti

Tourism - Florida

Retirement, Places of - Florida

Canadians - Retirement - Florida

Florida Social life and customs 20th century

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

ch. One Florida Dreaming -- ch. Two The Dream Next Door Going to Florida -- ch. Three Roosting in Eden -- ch. Four From Eden to Babel -- ch. Five From Babel to the Clubhouse Snowbirds in Search of Community -- ch. Six A Canadian Snowbird Case Study -- ch. Seven Coming Home What Florida Means to the North.

Sommario/riassunto

A portrait of the social and cultural effects of flying south for the winter.