Formulation and analytical development for low-dose oral drug products
By: [edited by] Jack Zheng.
Contributors: Zheng, Jack.
Publisher: John Wiley & Sons
Published: 2008
Place of publication: Hoboken, N.J
Language: eng
ISBN-13: 9780470056097
Subjects: Drugs -- Dose-response relationship; Drugs -- Dosage; Oral medication; Drug development; Chemistry, Pharmaceutical -- methods; Administration, Oral; Drug Evaluation, Preclinical -- methods; Drug Industry
Notes: Includes bibliographical references and index.
Table of contents: title: An overview / Jack Y. Zheng; title: Challenges and strategies in formulation development of oral solid low-dose drug products / Jack Y. Zheng; title: Particle size of drug substance and product content uniformity: theoretical considerations / Kevin C. Johnson; title: Development of low-dose formulations using fluidized bed granulation / J. Joe Zhou, and Ralph Lipp; title: Development of low-dose solid oral formulations using wet granulation / Ahmad Almaya; title: Challenges in development and scale-up of low dose drug products by dry granulation: a case study / Mary T. am Ende ... [et al.]; title: Development of low-dose solid oral tablets using direct compression / Jack Y. Zheng and Robert L. Ternik; title: Reduction of particle size of drug substance for low-dose drug products / Christopher L. Burcham ... [et al.]; title: Function, quality, and regulations of pharmaceutical excipients for oral solid state dosage forms / Jack Y. Zheng; title: Analytical method development: challenges and solutions for low-dose oral dosage forms / Beverly Nickerson ... [et al.]; title: In vitro dissolution testing and method development / Vivian A. Gray, Jack Y. Zheng, and Norman N. Sesi; title: Analysis of physical transformation of API during manufacture and storage / Gregory A. Stephenson; title: Physical characterization tests for API used in low-dose formulations / Ronald G. Lacocca; title: An excipient library approach to analytical development for low-dose, solid oral dosage form drug products / Qing Chang ... [et al.]; title: Cleaning verification for highly potent compounds / Brian W. Pack; title: Containment challenges and strategies for potent compounds in the pharmaceutical industry / Victoria Cathcart, Sarah Jones, Beverly Nickerson; title: Sample handling and containment in analytical testing laboratories / David Pattavina, Nancy Sage, Beverly Nickerson.