Gauge repeatability and reproducibility for accessing variability during dissolution testing: A technical note

Gao, Ziwen; Moore, Terry W.; Smith, Anjanette P.; Doub, William H.; Westenberger, Benjamin J.; Buhse, Lucinda F.

doi:10.1208/pt0804082

Cited by 16 publications

(15 citation statements)

References 24 publications

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“…• Samples: NCDA #2, 10 mg of prednisone tablets used in this study have been well characterized in a Gauge R&R study. From that study, 9 the mean and standard deviation of percentage release of at 30 min were 31.4% ± 1.38%, respectively. • Sampling: Automated ultraviolet (UV) sampling system with monitoring at 242 nm by using a 0.5-cm path length cell.…”

Section: Dissolution Testingmentioning

confidence: 77%

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Effects of Vessel Geometric Irregularity on Dissolution Test Results

Gao

Ahadi

Moore

et al. 2011

Journal of Pharmaceutical Sciences

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Section: Dissolution Testingmentioning

confidence: 77%

“…Many reports have been published concerning the effects of alignment of the instrument, vibration, deaeration, and analyst. [6][7][8][9][10][11] Some of these discussions have led to tightened specifications in the mechanical calibration of dissolution apparatus.…”

Section: Introductionmentioning

confidence: 99%

Effects of Vessel Geometric Irregularity on Dissolution Test Results

Gao

Ahadi

Moore

et al. 2011

Journal of Pharmaceutical Sciences

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“…A second issue arises with vessel geometry. While it is recognized that there are (22,23). The USP Prednisone Tablets RS for PVT have also shown dissolution rate and variability differences among vessel manufacturers (24).…”

Section: Outstanding Issuesmentioning

confidence: 99%

Overview of Dissolution Instrument Qualification, Including Common Pitfalls

Martin¹,

Gray²

2011

Dissolution Technol.

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“…The recommended acceptance criteria should include mean value, standard deviation, and stability. Gauge repeatability and reproducibility studies can be useful for determining the mean and variability of a dosage form and for improving equipment variability (12). If different from the product(s) to be tested, a reference product should be sensitive to the same variables that affect the products tested in that laboratory.…”

Section: New Fip Instrument Qualification Recommendationmentioning

confidence: 99%

FIP Position Paper on Qualification of Paddle and Basket Dissolution Apparatus

Brown¹,

Buhse²,

Friedel³

et al. 2009

Dissolution Technol.

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The qualification process for ensuring that a paddle or basket apparatus is suitable for its intended use is a highly debated and controversial topic. Different instrument qualification and suitability methods have been proposed by the pharmacopeias and regulatory bodies. In an effort to internationally harmonize dissolution apparatus suitability requirements, the International Pharmaceutical Federation's (FIP) Dissolution/Drug Release Special Interest Group (SIG) reviewed current instrument suitability requirements listed in the United States, European, and Japanese pharmacopeias and the International Conference on Harmonization (ICH) Topic Q4B on harmonization of pharmacopoeial methods in its Annex 7, Dissolution Test General. In addition, the SIG reviewed the Food and Drug Administration (FDA) Draft Guidance for Industry, "The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2-Current Good Manufacturing Practice (CGMP)" and the related ASTM Standard E2503-07. Based on this review and several in-depth discussions, the FIP Dissolution/Drug Release SIG recommends that the qualification of a dissolution test instrument should be performed following the calibration requirements as indicated in the FDA (draft) guidance. If additional system performance information is desired, a performance verification test using U.S. Pharmacopeia Reference Standard tablets or an established in-house reference product can be conducted. Any strict requirement on the use of a specific performance verification test tablet is not recommended at this time.

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Gauge repeatability and reproducibility for accessing variability during dissolution testing: A technical note

Cited by 16 publications

References 24 publications

Effects of Vessel Geometric Irregularity on Dissolution Test Results

Effects of Vessel Geometric Irregularity on Dissolution Test Results

Overview of Dissolution Instrument Qualification, Including Common Pitfalls

FIP Position Paper on Qualification of Paddle and Basket Dissolution Apparatus

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