Pharmaceutical solid polymorphism in drug development and regulation

Advanced Drug Delivery Reviews

Volumn 56, Issue 3, 2004, Pages 235-236

  Raw, Andre S ^a   Yu, Lawrence X ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RITONAVIR;

CRYSTALLIZATION; DRUG BIOAVAILABILITY; DRUG CONTROL; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SCREENING; DRUG STABILITY; DRUG STRUCTURE; EDITORIAL; KINETICS; PHARMACEUTICAL ENGINEERING; PHARMACEUTICAL SOLID POLYMORPHISM; PHYSICAL CHEMISTRY; PREDICTION; PRIORITY JOURNAL; SIMULATION; SOLID STATE; STRUCTURE ANALYSIS; TECHNOLOGY; THERMODYNAMICS;

EID: 1042298895     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.addr.2003.10.004     Document Type: Editorial

References (3)

1. Byrn S., Pfeiffer R., Ganey M., Hoiberg C., Poochikian G. Pharmaceutical solids: a strategic approach to regulatory considerations. Pharm. Res. 12:1995;945-954.
2. International Conference on Harmonization Q6A Guideline: Specifications for New Drug Substances and Products: Chemical Substances, October 1999.
3. Yu L.X., Furness M.S., Raw A., Woodland Outlaw K.P., Nashed N.E., Ramos E., Miller S.P.F., Adams R.C., Fang F., Patel R.M., Holcombe F.O. Jr., Chiu Y., Hussain A.S. Scientific considerations of pharmaceutical solid polymorphism in abbreviated new drug applications. Pharm. Res. 20:2003;531-536.