WHO Expert Committee on Specifications for Pharmaceutical Preparations fortieth report.
This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Annexes include: a list of available international...
Salvato in:
| Enti autori: | , , |
|---|---|
| Natura: | Elettronico eBook |
| Lingua: | inglese |
| Pubblicazione: |
Geneva :
World Health Organization,
2006.
|
| Serie: | Technical report series (World Health Organization) ;
937. |
| Soggetti: | |
| Accesso online: | An electronic book accessible through the World Wide Web; click to view |
| Tags: |
Nessun Tag, puoi essere il primo ad aggiungerne!!
|
| Riassunto: | This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Annexes include: a list of available international chemical reference substances and international infrared spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies. |
|---|---|
| Descrizione del documento: | "WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva, 24-28 October 2005"--P. vii. |
| Descrizione fisica: | x, 461 p. : ill. |
| Bibliografia: | Includes bibliographical references. |