Dissolution Testing and Metrological Measurement of Quality for Solid Oral Dosage Forms - Pharmaceutical Technology

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Dissolution Testing and Metrological Measurement of Quality for Solid Oral Dosage Forms
USP applies metrological principles to the dissolution procedure alone and in collaborative studies to understand and minimize potential sources of variability.


Pharmaceutical Technology


References

1. ISO, Guide 99: International Vocabulary of Basic and General Terms in Metrology (VIM), (Geneva, Switzerland, ISO, 2004).

2. 21 USC 351 501(a)(2)(B).

3. R. Hanson and V. Gray, Handbook of Dissolution Testing, 3rd ed. (Dissolution Technologies, Hockessin, DE, 2004).

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).

7. L. Bhattacharyya et al., "The Value of USP Public Standards for Therapeutic Products," Pharm. Res. 21 (10), 1725–1731.

8. L. Buhse, "Dissolution Measurement Systems: Current State and Opportunities for Improvement," presented at FDA Advisory Committee for Pharmaceutical Science meeting, Rockville, MD, 3–4 May 2005.

9. FDA, Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (2000) accessed at http://www.fda.gov/cder/guidance/3618fnl.pdf on Mar. 22, 2007.

10. WHO, Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability (2005) accessed at http://www.who.int/medicines/services/expertcommittees/pharmprep/QAS04_093Rev4_final.pdf on Mar. 22, 2007.

11. National Institute of Standards and Technology, "Guidance on Federal Conformity Assessment Activities," Fed. Regist. 65, 48894–48902 (2000).

12. FDA, Guidance for Industry: Text on Validation of Analytical Procedures (1995) accessed at http://www.fda.gov/cder/guidance/ichq2a.pdf on 26 March 2007.

13. J. Dressman and J. Kramer, Pharmaceutical Dissolution Testing (Boca Raton, FL, Taylor & Francis, 2005).

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).


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