Found: 12
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Performance Properties of the Population Bioequivalence Approach for In Vitro Delivered Dose for Orally Inhaled Respiratory Products.
- Published in:
- AAPS Journal, 2014, v. 16, n. 1, p. 89, doi. 10.1208/s12248-013-9543-x
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- Publication type:
- Article
Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid.
- Published in:
- AAPS Open, 2022, v. 8, n. 1, p. 1, doi. 10.1186/s41120-022-00066-1
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- Publication type:
- Article
Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability.
- Published in:
- AAPS PharmSciTech, 2021, v. 22, n. 7, p. 1, doi. 10.1208/s12249-021-02063-1
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- Publication type:
- Article
Evaluation of the Sensitivity and Robustness of Modified Chi-Square Ratio Statistic for Cascade Impactor Equivalence Testing Through Monte Carlo Simulations.
- Published in:
- AAPS PharmSciTech, 2020, v. 21, n. 5, p. 1, doi. 10.1208/s12249-020-01664-6
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- Publication type:
- Article
Performance of the Population Bioequivalence (PBE) Statistical Test with Impactor Sized Mass Data.
- Published in:
- AAPS PharmSciTech, 2019, v. 20, n. 7, p. N.PAG, doi. 10.1208/s12249-019-1507-8
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- Publication type:
- Article
Cascade Impactor Equivalence Testing: Comparison of the Performance of the Modified Chi-Square Ratio Statistic (mCSRS) with the Original CSRS and EMA's Average Bioequivalence Approach.
- Published in:
- AAPS PharmSciTech, 2019, v. 20, n. 6, p. N.PAG, doi. 10.1208/s12249-019-1443-7
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- Publication type:
- Article
Performance of the Population Bioequivalence (PBE) Statistical Test Using an IPAC-RS Database of Delivered Dose from Metered Dose Inhalers.
- Published in:
- AAPS PharmSciTech, 2018, v. 19, n. 3, p. 1410, doi. 10.1208/s12249-017-0941-8
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- Publication type:
- Article
Challenges and Opportunities in Implementing the FDA Default Parametric Tolerance Interval Two One-Sided Test for Delivered Dose Uniformity of Orally Inhaled Products.
- Published in:
- AAPS PharmSciTech, 2011, v. 12, n. 4, p. 1144, doi. 10.1208/s12249-011-9683-1
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- Publication type:
- Article
Relative Precision of Inhaler Aerodynamic Particle Size Distribution (APSD) Metrics by Full Resolution and Abbreviated Andersen Cascade Impactors (ACIs): Part 2-Investigation of Bias in Extra-Fine Mass Fraction with AIM-HRT Impactor.
- Published in:
- AAPS PharmSciTech, 2010, v. 11, n. 3, p. 1115, doi. 10.1208/s12249-010-9473-1
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- Publication type:
- Article
Relative Precision of Inhaler Aerodynamic Particle Size Distribution (APSD) Metrics by Full Resolution and Abbreviated Andersen Cascade Impactors (ACIs): Part 1.
- Published in:
- AAPS PharmSciTech, 2010, v. 11, n. 2, p. 843, doi. 10.1208/s12249-010-9452-6
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- Publication type:
- Article
Improved Quality Control Metrics for Cascade Impaction Measurements of Orally Inhaled Drug Products (OIPs).
- Published in:
- AAPS PharmSciTech, 2009, v. 10, n. 4, p. 1276, doi. 10.1208/s12249-009-9312-4
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- Publication type:
- Article
Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6, 2016 in Gaithersburg, MD.
- Published in:
- 2017
- By:
- Publication type:
- Report