1.

Record Nr.

UNINA9910783139403321

Titolo

The textbook of pharmaceutical medicine [[electronic resource]]

Pubbl/distr/stampa

London, : BMJ Books, 2002

ISBN

1-280-19787-0

9786610197873

1-4051-4606-0

1-4237-1777-5

Edizione

[4th ed. /]

Descrizione fisica

1 online resource (896 p.)

Collana

New York Academy of Sciences

Altri autori (Persone)

GriffinJ. P (John Parry)

O'GradyJohn

Disciplina

615.1

Soggetti

Pharmaceutical chemistry

Pharmacology

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Includes index.

Previous ed.: / edited by J.P. Griffin, J. O'Grady, P.F. D'Arcy. Belfast : Queen's University of Belfast, c1998.

Nota di contenuto

Contents; Contributors; Preface; Acknowledgements; The editors; 1: Discovery of new medicines; 2: Pharmaceutical development; 3: Toxicity testing; 4: Exploratory development; 5: Clinical pharmacokinetics; 6: Clinical trials and good clinical practice; 7: Medical statistics; 8: Development of medicines: full development; 9: The medical department; 10: Medical marketing; 11: Information and promotion; 12: The supply of unlicensed medicines for particular patient use; 13: Legal and ethical issues relating to medicinal products; 14: The safety of medicines

15: The development of the control of human medicines in Europe from classical times to the year 200016: Technical requirements for registration of pharmaceuticals for human use: the ICH process and the common technical document; 17: The regulation of drug products by the United States Food and Drug Administration; 18: The US FDA in the drug development, evaluation and approval process; 19: Regulatory and clinical trial systems in Japan; 20: Economics of healthcare; 21: Controls on NHS medicines prescribing and expenditure in the UK (a



historical perspective); Appendix 1; Appendix 2

PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY Constitution and ProcedureIndex

Sommario/riassunto

This edition has totally revised chapters on drug regulation in the USA, with new contributor, Dr Peter Barton Hutt formerly FDA Special Counsel. New contributions regarding pharmaco-economics are covered in two new chapters.