Formulation and analytical development for low-dose oral drug products / edited by Jack Zheng.
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| Year of Publication: | 2009 |
| Language: | English |
| Online Access: | |
| Physical Description: | xxiii, 461 p. :; ill. |
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Table of Contents:
- 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 ... [et al.]
- 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 ... [et al.]
- Function, quality, and regulations of pharmaceutical excipients for oral solid dosage forms / Jack Y. Zheng
- Analytical method development: challenges and solutions for low-dose oral dosage forms / Beverly Nickerson ... [et al.]
- 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 ... [et al.]
- 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.