Dissolution testing and metrological measurement of quality for solid oral dosage forms

Pharmaceutical Technology

Volumn 31, Issue 5, 2007, Pages 68-74

  Manning, Ronald G ^a   Wahab, Samir Z ^b   Brown, William E ^c   Hauck, Walter W ^c   Schuber, Stefan ^d   Williams, Roger L ^e  

^a Scientific Outreach   (United States)

^b USP Research/Development Laboratory   (United States)

^c NONE   (United States)

^d Off of Extramural Activities Review   (United States)

^e UNITED STATES PHARMACOPEIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DISSOLUTION; MEASUREMENT THEORY; PHARMACODYNAMICS;

DISSOLUTION PROCEDURE; METROLOGICAL PRINCIPLES; ORAL DOSAGE FORMS;

DRUG DOSAGE;

BIOAVAILABILITY; BIOEQUIVALENCE; DISSOLUTION; DRUG CAPSULE; ORAL DRUG ADMINISTRATION; QUALITY CONTROL; REVIEW; TABLET;

EID: 34248598774     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (22)

1. ISO, Guide 99: International Vocabulary of Bask and General Terms in Metrology (VIM), (Geneva, Switzerland, ISO, 2004).
2. 21 USC 351 §501(a)(2)(B).
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4. US Pharmacopeial Convention, United States Pharmacopeia XIX (USP, Rockville, MD, 1975), xv-xvi.
5. Public Law 98-417 (1984).
6. G.L. Amidon et al., "A Theoretical Basis for a Biopharmaceutics Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability," Pharm. Res. 12 (3), 413-420 (1995).
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14. USP, USP 30-NF 25: Dissolution 〈711〉 (US Pharmacopeial Convention, Inc., Rockville, MD, 2007), 277-284.
15. ISO, Guide 5725: Accuracy (Trueness and Precision) of Measurement Methods and Results. Parts 1-6 (Geneva, Switzerland, ISO, 1994).
16. USP, "The USP Performance Test: Mechanical Calibration vs. a Periodic Performance Verification Test with Reference Standard Tablets (Calibrators)" [and links therein]. Web page, 2006, accessed at www.usp.org/ USPNF/notices/calibratorsPublicStatement. html on Mar. 26 2007.
17. P. Nithyanandan et al., "Evaluation of the Sensitivity of USP Prednisone Tablets to Dissolved Gas in the Dissolution Medium Using USP Apparatus 2," Dissolution Technol. 13 (3), 15-18 (2006).
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22. ASTM Committee E55 on Pharmaceutical Application of Process Analytical Technology and Subcommittee E55.03 on General Pharmaceutical Standards, Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus, (Work Item Number WK9936) (ASTM, West Conshohocken, PA, 2006).