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Handbook of Pharmaceutical Manufacturing Formulations - Sarfaraz K. Niazi

Handbook of Pharmaceutical Manufacturing Formulations

Volume Two, Uncompressed Solid Products
Buch | Hardcover
392 Seiten
2009 | 2nd New edition
Crc Press Inc (Verlag)
978-1-4200-8118-3 (ISBN)
CHF 287,95 inkl. MwSt
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Handbook of Pharmaceutical Manufacturing Formulations
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, Volume Two include:








the fundamental issues of good manufacturing practices



formulations for more than 400 pharmaceutical products, including currently approved products and innovative products such as small proteins, instantly liquifiable powders, and nanoparticles



access to US FDA guidelines, as well as all major guidelines around the world



identification and inclusion of the most often approved capsules and powders in the US

Niazi, Sarfaraz K.

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.

Erscheint lt. Verlag 21.9.2009
Verlagsort Bosa Roca
Sprache englisch
Maße 216 x 279 mm
Gewicht 1429 g
Themenwelt Medizin / Pharmazie Medizinische Fachgebiete Pharmakologie / Pharmakotherapie
Medizin / Pharmazie Pflege
Medizin / Pharmazie Pharmazie
Technik
ISBN-10 1-4200-8118-7 / 1420081187
ISBN-13 978-1-4200-8118-3 / 9781420081183
Zustand Neuware
Informationen gemäß Produktsicherheitsverordnung (GPSR)
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