WHO Expert Committee on Specifications for Pharmaceutical Preparations: fortieth report
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Geneva
World Health Organization
2006
|
| Schriftenreihe: | Technical report series (World Health Organization)
937 |
| Schlagworte: | |
| Beschreibung: | "WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva, 24-28 October 2005"--P. vii Includes bibliographical references 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 |
| Beschreibung: | x, 461 p. |
| ISBN: | 9241209372 |
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| 500 | |a "WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva, 24-28 October 2005"--P. vii | ||
| 500 | |a Includes bibliographical references | ||
| 500 | |a 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 | ||
| 650 | 4 | |a Drugs |x Standards |v Congresses | |
| 650 | 4 | |a Pharmacopoeias |v Congresses | |
| 650 | 4 | |a Drugs |x Quality control |v Congresses | |
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Datensatz im Suchindex
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| dewey-full | 615.855 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.855 |
| dewey-search | 615.855 |
| dewey-sort | 3615.855 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
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| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:44:22Z |
| institution | BVB |
| isbn | 9241209372 |
| language | English |
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| physical | x, 461 p. |
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| spelling | WHO Expert Committee on Specifications for Pharmaceutical Preparations fortieth report Geneva World Health Organization 2006 x, 461 p. txt rdacontent c rdamedia cr rdacarrier Technical report series (World Health Organization) 937 "WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva, 24-28 October 2005"--P. vii Includes bibliographical references 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 Drugs Standards Congresses Pharmacopoeias Congresses Drugs Quality control Congresses (DE-588)1071861417 Konferenzschrift gnd-content World Health Organization Sonstige oth WHO Expert Committee on Specifications for Pharmaceutical PreparationsXXn(40thXXd2005 Sonstige oth |
| spellingShingle | WHO Expert Committee on Specifications for Pharmaceutical Preparations fortieth report Drugs Standards Congresses Pharmacopoeias Congresses Drugs Quality control Congresses |
| subject_GND | (DE-588)1071861417 |
| title | WHO Expert Committee on Specifications for Pharmaceutical Preparations fortieth report |
| title_auth | WHO Expert Committee on Specifications for Pharmaceutical Preparations fortieth report |
| title_exact_search | WHO Expert Committee on Specifications for Pharmaceutical Preparations fortieth report |
| title_full | WHO Expert Committee on Specifications for Pharmaceutical Preparations fortieth report |
| title_fullStr | WHO Expert Committee on Specifications for Pharmaceutical Preparations fortieth report |
| title_full_unstemmed | WHO Expert Committee on Specifications for Pharmaceutical Preparations fortieth report |
| title_short | WHO Expert Committee on Specifications for Pharmaceutical Preparations |
| title_sort | who expert committee on specifications for pharmaceutical preparations fortieth report |
| title_sub | fortieth report |
| topic | Drugs Standards Congresses Pharmacopoeias Congresses Drugs Quality control Congresses |
| topic_facet | Drugs Standards Congresses Pharmacopoeias Congresses Drugs Quality control Congresses Konferenzschrift |
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