Pharmaceutical Dosage Forms Parenteral Medications
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Auteur:
Kenneth E. Avis
Herbert A. Lieberman
- Engels
- Hardcover
- 9780824790202
- 01 april 1993
- 592 pagina's
Samenvatting
Updated and enlarged to three volumes, the 2nd edition of "Pharmaceutical Dosage Forms: Parenteral Medications" examines every important aspect of sterile drug products. This volume offers comprehensive coverage of medical devices, quality assurance and regulatory issues.
Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.
Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.
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Inhoud
- Taal
- en
- Bindwijze
- Hardcover
- Oorspronkelijke releasedatum
- 01 april 1993
- Aantal pagina's
- 592
- Illustraties
- Nee
Betrokkenen
- Hoofdauteur
- Kenneth E. Avis
- Tweede Auteur
- Herbert A. Lieberman
- Hoofdredacteur
- Kenneth E. Avis
- Tweede Redacteur
- Herbert A. Lieberman
- Hoofduitgeverij
- Routledge
Overige kenmerken
- Editie
- 2
- Extra groot lettertype
- Nee
- Product breedte
- 178 mm
- Product lengte
- 254 mm
- Studieboek
- Nee
- Verpakking breedte
- 178 mm
- Verpakking hoogte
- 254 mm
- Verpakking lengte
- 254 mm
- Verpakkingsgewicht
- 1020 g
EAN
- EAN
- 9780824790202
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