
Handbook of Pharmaceutical Manufacturing Formulations
Volume Two, Uncompressed Solid Products
Sarfaraz K. Niazi(Autor*in)
CRC Press
2. Auflage
Erschienen am 21. September 2009
Buch
Hardcover
392 Seiten
978-1-4200-8118-3 (ISBN)
Artikel ist vergriffen; siehe Neuauflage
Beschreibung
Providing methodologies that can serve as a reference point for new formulations, the second volume covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution, and other similar products.Highlights from Uncompressed Solid Products, VolumeTwo include:the fundamental issues of good manufacturing practicesformulations for more than 400 pharmaceutical products, including currently approved products and innovative products such as small proteins, instantly liquifiable powders, and nanoparticlesaccess to US FDA guidelines, as well as all major guidelines around the worldidentification and inclusion of the most often approved capsules and powders in the US
Weitere Details
Sprache
Englisch
Verlagsort
Boca Raton, Florida
USA
Verlagsgruppe
Taylor & Francis
Zielgruppe
Für Beruf und Forschung
Pharmaceutical manufacturers, and quality assurance and production personnel.
Illustrationen
3 b/w images
Maße
Höhe: 279 mm
Breite: 216 mm
Gewicht
1429 gr
ISBN-13
978-1-4200-8118-3 (9781420081183)
Schweitzer Klassifikation
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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Volume Two, Uncompressed Solid Products
Buch
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Andere Ausgaben

Sarfaraz K. Niazi
Handbook of Pharmaceutical Manufacturing Formulations
Volume Two, Uncompressed Solid Products
Buch
09/2019
2. Auflage
CRC Press
79,00 €
Artikel ist vergriffen; siehe Neuauflage
Person
Niazi, Sarfaraz K.
Inhalt
REGULATORY AND MANUFACTURING GUIDELINES: U.S. FDA Good Manufacturing Practices. GMP Audit Template, EU Guidelines. Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use. Process Validation: General Principles and Practices. Bioequivalence Regulatory Compliance. Bioequi valence Regulatory Review Process and Audit. EU Guidelines to Good Manufacturing Practice. Preapproval Inspections. Formulation Factors in Uncompressed Dosage Forms. Bioequivalence Testing Protocols. Dissolution Testing of Uncompressed Solid Dosage Forms. Approved Excipients in Uncompressed Solid Dosage Forms. MANUFACTURING FORMULATIONS: Uncompressed Solids Formulations.