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Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet.
- Published in:
- Clinical Drug Investigation, 2022, v. 42, n. 8, p. 657, doi. 10.1007/s40261-022-01172-4
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- Publication type:
- Article
In vivo drug-drug interaction studies- A survey of all new molecular entities approved from 1987 to 1997<sup>*</sup>.
- Published in:
- Clinical Pharmacology & Therapeutics, 2000, v. 68, n. 3, p. 280, doi. 10.1067/mcp.2000.109366
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- Publication type:
- Article
In vitro metabolic interaction studies: Experience of the Food and Drug Administration<sup>*</sup>.
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- Clinical Pharmacology & Therapeutics, 1999, v. 66, n. 1, p. 9, doi. 10.1016/S0009-9236(99)70048-2
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- Publication type:
- Article
Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed‐Dose Combination Product: Phase 1 Results in Healthy Pre‐ and Postmenopausal Women.
- Published in:
- Clinical Pharmacology in Drug Development, 2024, v. 13, n. 6, p. 601, doi. 10.1002/cpdd.1399
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- Publication type:
- Article
Pharmacokinetics of Upadacitinib With the Clinical Regimens of the Extended‐Release Formulation Utilized in Rheumatoid Arthritis Phase 3 Trials.
- Published in:
- Clinical Pharmacology in Drug Development, 2019, v. 8, n. 2, p. 208, doi. 10.1002/cpdd.462
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- Publication type:
- Article
Development of In Vitro-In Vivo Correlation for Potassium Chloride Extended Release Tablet Formulation Using Urinary Pharmacokinetic Data.
- Published in:
- Pharmaceutical Research, 2017, v. 34, n. 7, p. 1527, doi. 10.1007/s11095-017-2179-2
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- Publication type:
- Article
In Vivo Bioequivalence and In Vitro Similarity Factor (f2) for Dissolution Profile Comparisons of Extended Release Formulations: How and When Do They Match?
- Published in:
- Pharmaceutical Research, 2011, v. 28, n. 5, p. 1144, doi. 10.1007/s11095-011-0377-x
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- Publication type:
- Article
Physiologically based pharmacokinetic modeling and simulations to inform dissolution specifications and clinical relevance of release rates on elagolix exposure.
- Published in:
- Biopharmaceutics & Drug Disposition, 2022, v. 43, n. 3, p. 98, doi. 10.1002/bdd.2315
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- Publication type:
- Article
Analysis of level A in vitro-in vivo correlations for an extended-release formulation with limited bioavailability.
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- Biopharmaceutics & Drug Disposition, 2013, v. 34, n. 5, p. 262, doi. 10.1002/bdd.1820
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- Publication type:
- Article
Relationships between in vitro drug dissolution and in vivo response.
- Published in:
- Biopharmaceutics & Drug Disposition, 2012, v. 33, n. 7, p. 347, doi. 10.1002/bdd.1808
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- Publication type:
- Article
Accelerating Drug Development in Pediatric Oncology With the Clinical Pharmacology Storehouse.
- Published in:
- Journal of Clinical Pharmacology, 2019, v. 59, n. 5, p. 625, doi. 10.1002/jcph.1359
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- Publication type:
- Article
Virtual Bioequivalence Assessment of Elagolix Formulations Using Physiologically Based Pharmacokinetic Modeling.
- Published in:
- AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00794-6
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- Publication type:
- Article
Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development.
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- AAPS Journal, 2022, v. 24, n. 2, p. 1, doi. 10.1208/s12248-022-00681-6
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- Publication type:
- Article
Development of In Vitro–In Vivo Correlation for Upadacitinib Extended-Release Tablet Formulation.
- Published in:
- AAPS Journal, 2019, v. 21, n. 6, p. 1, doi. 10.1208/s12248-019-0378-y
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- Publication type:
- Article
Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.
- Published in:
- AAPS Journal, 2018, v. 20, n. 6, p. 1, doi. 10.1208/s12248-018-0252-3
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- Publication type:
- Article
Application of Exposure-Response Analyses to Establish the Pharmacodynamic Similarity of a Once-Daily Regimen to an Approved Twice-Daily Dosing Regimen for the Treatment of HCV Infection.
- Published in:
- AAPS Journal, 2017, v. 19, n. 5, p. 1523, doi. 10.1208/s12248-017-0115-3
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- Publication type:
- Article
Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications.
- Published in:
- AAPS Journal, 2005, v. 7, n. 3, p. E503, doi. 10.1208/aapsj070351
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- Publication type:
- Article
Industry Perspective on Standardizing Food-Effect Studies for New Drug Development.
- Published in:
- 2018
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- Publication type:
- journal article
Metabolites and bioequivalence: past and present.
- Published in:
- 2004
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- Publication type:
- journal article
The product label: how pharmacokinetics and pharmacodynamics reach the prescriber.
- Published in:
- 2002
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- Publication type:
- journal article
Evaluation of US Food and Drug Administration Drug Label Recommendations for Coadministration of Antivirals and Acid‐Reducing Agents.
- Published in:
- Clinical Pharmacology & Therapeutics, 2022, v. 112, n. 5, p. 1088, doi. 10.1002/cpt.2723
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- Publication type:
- Article
New Era in Drug Interaction Evaluation: US Food and Drug Administration Update on CYP Enzymes, Transporters, and the Guidance Process.
- Published in:
- Journal of Clinical Pharmacology, 2008, v. 48, n. 6, p. 662, doi. 10.1177/0091270007312153
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- Publication type:
- Article