Drug product performance and interchangeability of multisource drug substances and drug products

Pharmacopeial Forum

Volumn 35, Issue 3, 2009, Pages 744-749

  Shargel, Leon ^a  

^a UNITED STATES PHARMACOPEIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EXCIPIENT; GENERIC DRUG; PRODRUG;

BIOEQUIVALENCE; DRUG ACTIVITY; DRUG FORMULATION; DRUG INTERCHANGEABILITY; DRUG MANUFACTURE; DRUG PURITY; DRUG QUALITY; DRUG SUBSTITUTION; MEDICAL LITERATURE; PHARMACEUTICAL EQUIVALENCE; REVIEW; UNITED STATES;

EID: 67649359954     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Review

References (5)

1. WHO. Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchange-ability. Geneva, Switzerland: WHO; 2005:7. Available at: www.who.int/entity/medicines/services/ expertcommit-tees/pharmprep/QAS04-093Rev4Jinal.pdf; accessed 8 December 2008.
2. Amidon GE, Peck GE, Block LH, et al. Proposed new USP general information chapter, Excipient Performance. Pharm Forum. 2007;33(6):1311-1323.
3. International Conference on Harmonization (ICH). Q8(R1) Pharmaceutical Development Revision 1. Available at: www.fda.gov/cder/guidance/8084dft. pdf; accessed 8 December 2008.
4. FDA. Guidance for Industry: Immediate-release Solid Oral Dosage Forms Scale-up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. Rockville, MD: FDA; 1995.
5. FDA. Guidance for Industry: SUPAC-MR: Modified-release Solid Oral Dosage Forms Scale-up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. Rockville, MD:FDA; 1997.