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Formulation and analytical development for low-dose oral drug products /
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...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
John Wiley & Sons,
©2009.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 037 | |a 10.1002/9780470386361 |b Wiley InterScience |n http://www3.interscience.wiley.com | ||
| 050 | 4 | |a RM301.8 |b .F67 2009 | |
| 060 | 4 | |a 2009 C-660 | |
| 060 | 4 | |a QV 744 |b F726 2009 | |
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| 049 | |a UAMI | ||
| 245 | 0 | 0 | |a Formulation and analytical development for low-dose oral drug products / |c edited by Jack Zheng. |
| 260 | |a Hoboken, N.J. : |b John Wiley & Sons, |c ©2009. | ||
| 300 | |a 1 online resource (xxiii, 461 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a An overview / Jack Y. Zheng -- Challenges and strategies in formulation development of oral solid low-dose drug products / Jack Y. Zheng -- Particle size of drug substance and product content uniformity: theoretical considerations / Kevin C. Johnson -- Development of low-dose formulations using fluidized bed granulation / J. Joe Zhou, and Ralph Lipp -- Development of low-dose solid oral formulations using wet granulation / Ahmad Almaya -- Challenges in development and scale-up of low dose drug products by dry granulation: a case study / Mary T. Am Ende [and others] -- Development of low-dose solid oral tablets using direct compression / Jack Y. Zheng and Robert L. Ternik -- Reduction of particle size of drug substance for low-dose drug products / Christopher L. Burcham [and others] -- Function, quality, and regulations of pharmaceutical excipients for oral solid dosage forms / Jack Y. Zheng. | |
| 505 | 0 | |a Analytical method development: challenges and solutions for low-dose oral dosage forms / Beverly Nickerson [and others] -- In vitro dissolution testing and method development / Vivian A. Gray, Jack Y. Zheng, and Norman N. Sesi -- Analysis of physical transformation of API during manufacture and storage / Gregory A. Stephenson -- Physical characterization tests for drug substances used in low-dose formulations / Ronald G. Lacocca -- An excipient library approach to analytical development for low-dose, solid oral dosage form drug products / Qing Chang [and others] -- Cleaning verification for highly potent compounds / Brian W. Pack -- Containment challenges and strategies for potent compounds in the pharmaceutical industry / Victoria Cathcart, Sarah Jones, Beverly Nickerson -- Sample handling and containment in analytical testing laboratories / David Pattavina, Nancy Sage, Beverly Nickerson -- Regulatory considerations in the development of low-dose solid oral drug products / Ravi S. Harapanhalli. | |
| 588 | 0 | |a Print version record. | |
| 520 | |a 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. | ||
| 546 | |a English. | ||
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Drugs |x Dose-response relationship. | |
| 650 | 0 | |a Drugs |x Dosage. | |
| 650 | 0 | |a Oral medication. | |
| 650 | 0 | |a Drug development. | |
| 650 | 0 | |a Pharmaceutical industry. | |
| 650 | 2 | |a Chemistry, Pharmaceutical |x methods | |
| 650 | 2 | |a Administration, Oral | |
| 650 | 2 | |a Drug Evaluation, Preclinical |x methods | |
| 650 | 2 | |a Drug Industry | |
| 650 | 2 | |a Dose-Response Relationship, Drug | |
| 650 | 6 | |a Médicaments |x Relations dose-effet. | |
| 650 | 6 | |a Médicaments |x Administration par voie orale. | |
| 650 | 6 | |a Médicaments |x Développement. | |
| 650 | 6 | |a Industrie pharmaceutique. | |
| 650 | 7 | |a MEDICAL |x Drug Guides. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Pharmacy. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Nursing |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a Pharmaceutical industry |2 fast | |
| 650 | 7 | |a Drug development |2 fast | |
| 650 | 7 | |a Drugs |x Dosage |2 fast | |
| 650 | 7 | |a Drugs |x Dose-response relationship |2 fast | |
| 650 | 7 | |a Oral medication |2 fast | |
| 700 | 1 | |a Zheng, Jack. | |
| 758 | |i has work: |a Formulation and analytical development for low-dose oral drug products (Text) |1 https://id.oclc.org/worldcat/entity/E39PCGhx6pF69KRDYDfGcttPHC |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |t Formulation and analytical development for low-dose oral drug products. |d Hoboken, N.J. : John Wiley & Sons, ©2009 |z 9780470056097 |z 0470056096 |w (DLC) 2008009573 |w (OCoLC)213008102 |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=427896 |z Texto completo |
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