Metrology and USP dissolution

Thomas S. Foster, Darrell R. Abernethy, William F. Koch, Walter W. Hauck

Research output: Contribution to journalArticle

Abstract

In studies cited in this commentary (6-15, 20) and in various internal and external discussions with its Expert Committee members, stakeholders, and others, USP has determined that a PVT performed at periodic intervals, in addition to mechanical calibration, is required to ensure the integrity and reliability of the dissolution procedure when referenced in the USP performance test and in private regulatory drug product specifications. USP believes that additional work is needed to improve its General Chapters that function to ensure the consistency of drug products and expand them to products other than nonsolution orally administered dosage forms. USP also is in accord with an often stated view that new approaches to assess drug product performance in vitro are needed. In the long term, USP envisions an evolved set of approaches to assess drug product performance for all non-solution dosage forms over time following regulatory approval. Although the use of a PVT with some kind of physical article will be needed in the short term, these newer approaches could offer better public health protection and ease of use by pharmaceutical manufacturers. It is important not to abandon current approaches that have worked well before new opportunities become available. USP hopes that this work can advance jointly with FDA, industry, and other stakeholders.

Original languageEnglish (US)
Pages (from-to)186-190
Number of pages5
JournalPharmaceutical Technology
Volume32
Issue number3
StatePublished - Mar 2008
Externally publishedYes

Fingerprint

Pharmaceutical Preparations
Dosage Forms
Committee Membership
Calibration
Industry
Public Health
In Vitro Techniques

ASJC Scopus subject areas

  • Biophysics
  • Pharmaceutical Science
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Foster, T. S., Abernethy, D. R., Koch, W. F., & Hauck, W. W. (2008). Metrology and USP dissolution. Pharmaceutical Technology, 32(3), 186-190.

Metrology and USP dissolution. / Foster, Thomas S.; Abernethy, Darrell R.; Koch, William F.; Hauck, Walter W.

In: Pharmaceutical Technology, Vol. 32, No. 3, 03.2008, p. 186-190.

Research output: Contribution to journalArticle

Foster, TS, Abernethy, DR, Koch, WF & Hauck, WW 2008, 'Metrology and USP dissolution', Pharmaceutical Technology, vol. 32, no. 3, pp. 186-190.
Foster TS, Abernethy DR, Koch WF, Hauck WW. Metrology and USP dissolution. Pharmaceutical Technology. 2008 Mar;32(3):186-190.
Foster, Thomas S. ; Abernethy, Darrell R. ; Koch, William F. ; Hauck, Walter W. / Metrology and USP dissolution. In: Pharmaceutical Technology. 2008 ; Vol. 32, No. 3. pp. 186-190.
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