Quality by design for generic drugs

Pharmaceutical Technology

Volumn 33, Issue 10, 2009, Pages 122-127

  Yu, Lawrence X ^a   Lionberger, Robert ^a   Olson, Michael C ^a   Johnston, Gordon ^a   Buehler, Gary ^a   Winkle, Helen ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

COMMON UNDERSTANDING; GENERIC DRUGS; GENERIC PHARMACEUTICAL ASSOCIATION; INDUSTRY REPRESENTATIVES; QUALITY BY DESIGNS; US FOOD AND DRUG ADMINISTRATION;

DRUG PRODUCTS PLANTS;

DRUG PRODUCTS;

EXCIPIENT; GENERIC DRUG;

BIOEQUIVALENCE; CONTROL STRATEGY; DRUG APPROVAL; DRUG DESIGN; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG MONITORING; DRUG PROGRAM; DRUG QUALITY; EXCIPIENT COMPATIBILITY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; MEDICAL SOCIETY; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; UNITED STATES;

EID: 77952019734     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. ICH, ICH Q8(R1) Pharmaceutical Development/Annex (Genera, November 2008).
2. L. X. Yu. "Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control," Pharm. Res, 25 (4), 781-791 (2008).
3. R-Lionberger et al., "Quality by Design: Concepts for ANDAs,'" The AAPSjoumai. 10(2), 268-276 (200ft).
4. L.S. Lee, A. Raw,and L.X.Yu,"Dissolution Testing," in Biophar-maceutics Applications in Drug Development, R. Krishna and Lawrence X. Yu, Eds. (Springer, New York, NY, 2008), pp. 47-74.
5. ICH, ICH Q9 Quality Risk Management (Geneva, November 2005)
6. ICH Quality Implementation Working Group, 08, Q9, and Q10 Questions and Answers, www.ich.org/LOB/media/MEDIA5290. pdf, accessed Aug. 26,MOft.