03270nam a22003734a 4500 ebr10296483 CaPaEBR m u cr cn||||||||| 080303s2009 njua sb 001 0 eng 2008009573 101467523 DNLM 9780470056097 (cloth) 0470056096 (cloth) CaPaEBR CaPaEBR (OCoLC)352829614 RM301.8 .F67 2009eb 615/.1 22 Formulation and analytical development for low-dose oral drug products [electronic resource] / edited by Jack Zheng. Hoboken, N.J. : John Wiley & Sons, c2009. xxiii, 461 p. : ill. 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. Electronic reproduction. Palo Alto, Calif. : ebrary, 2013. Available via World Wide Web. Access may be limited to ebrary affiliated libraries. Drugs Dose-response relationship. Drugs Dosage. Oral medication. Drug development. Electronic books. local Zheng, Jack. ebrary, Inc. http://site.ebrary.com/lib/rucke/Doc?id=10296483 An electronic book accessible through the World Wide Web; click to view 77341 77341