Formulation and Analytical Development for Low-Dose Oral Drug Products (Record no. 15525)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 01904nam a2200157Ia 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 140223b2009 xxu||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780470056097 |
| Terms of availability | 0.00 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.1 |
| Item number | FOR |
| 245 ## - TITLE STATEMENT | |
| Title | Formulation and Analytical Development for Low-Dose Oral Drug Products |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc | New Jersey |
| Name of publisher, distributor, etc | John and Wiley Sons, Inc. |
| Date of publication, distribution, etc | 2009 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 461p |
| 500 ## - GENERAL NOTE | |
| General note | There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students. excipient background, manufacturing platform technology, using fluidized bed granulation, drug particle size distribution, solid oral drug products, drug substance particle size, granulation vehicle, dry granulation processing, pharmaceutical development report, cleaning verification assays, content uniformity criteria, volume dissolution vessels, product content uniformity, ideal mixing model, fluidized bed granulation process, small volume vessels, dissolution method development, cut potency, charged aerosol detection, granulation particle size distribution, poor content uniformity, tooling strength, final blending process, percentage drug dissolved, tablet content uniformity |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Zheng, Jack |
| Relator term | Editor |
| 9 (RLIN) | 108523 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Item type | Book |
| 995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE] | |
| Origin of item (home branch) (free text) | Pharmacy Reference |
| Genre | P0006927 |
| Section | 615.1 |
| Recipient parent organisation code | P0006927 |
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