TY  - BOOK
AU  - Zheng,Jack
TI  - Formulation and analytical development for low-dose oral drug products
SN  - 9780470056097 (cloth)
AV  - RM301.8 .F67 2009
U1  - 615.1 22
PY  - 2009///]
CY  - Hoboken, N.J.
PB  - John Wiley & Sons
KW  - Drugs
KW  - Dose-response relationship
KW  - Dosage
KW  - Oral medication
KW  - Drug development
KW  - Chemistry, Pharmaceutical
KW  - methods
KW  - Administration, Oral
KW  - Drug Evaluation, Preclinical
KW  - Drug Industry
N1  - Includes bibliographical references and index; 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
UR  - http://www.loc.gov/catdir/enhancements/fy0827/2008009573-d.html
UR  - http://www.loc.gov/catdir/enhancements/fy0827/2008009573-t.html
ER  -