Found: 40
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Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space.
- Published in:
- AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00938-2
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- Article
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products.
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- AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-024-00886-x
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- Article
Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis.
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- AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00822-5
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- Article
Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 585, doi. 10.1002/psp4.12907
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- Article
Physiologically based Pharmacokinetic Models under the Prism of the Finite Absorption Time Concept.
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- Pharmaceutical Research, 2023, v. 40, n. 2, p. 419, doi. 10.1007/s11095-022-03357-0
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- Article
An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow.
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- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00699-w
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- Publication type:
- Article
A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development.
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- AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00713-1
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- Article
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models.
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- AAPS Journal, 2021, v. 23, n. 4, p. 1, doi. 10.1208/s12248-021-00601-0
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- Article
Understanding effect site pharmacology of uprifosbuvir, a hepatitis C virus nucleoside inhibitor: Case study of a multidisciplinary modeling approach in drug development.
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- CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 7, p. 658, doi. 10.1002/psp4.12644
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- Article
Correction to: Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective.
- Published in:
- 2021
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- Publication type:
- Correction Notice
Correction to: Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products.
- Published in:
- 2021
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- Publication type:
- Correction Notice
Can PBPK Modeling Streamline Food Effect Assessments?
- Published in:
- Journal of Clinical Pharmacology, 2020, v. 60, p. S98, doi. 10.1002/jcph.1678
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- Publication type:
- Article
Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective.
- Published in:
- AAPS Journal, 2020, v. 22, n. 6, p. N.PAG, doi. 10.1208/s12248-020-00508-2
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- Publication type:
- Article
Can PBPK Modeling Streamline Food Effect Assessments?
- Published in:
- Journal of Clinical Pharmacology, 2020, v. 60, p. S98, doi. 10.1002/jcph.1678
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- Publication type:
- Article
Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00470-z
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- Publication type:
- Article
Biowaiver Applications in Support of a Polymorph During Late-Stage Clinical Development of Verubecestat—Current Challenges and Future Opportunities for Global Regulatory Alignment.
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- AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0396-9
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- Article
Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link—a Workshop Summary Report.
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- AAPS Journal, 2019, v. 21, n. 2, p. 1, doi. 10.1208/s12248-019-0298-x
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- Article
PBPK Absorption Modeling: Establishing the In Vitro-In Vivo Link—Industry Perspective.
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- AAPS Journal, 2019, v. 21, n. 2, p. 1, doi. 10.1208/s12248-019-0292-3
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- Article
Clinical Endpoint Bioequivalence Studies Are Needed: A Perspective From Brand Drugs.
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- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 2, p. 298, doi. 10.1002/cpt.1245
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- Article
Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.
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- AAPS Journal, 2018, v. 20, n. 6, p. 1, doi. 10.1208/s12248-018-0252-3
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- Article
Physiologically Based Absorption Modeling of Salts of Weak Bases Based on Data in Hypochlorhydric and Achlorhydric Biorelevant Media.
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- AAPS PharmSciTech, 2018, v. 19, n. 7, p. 2851, doi. 10.1208/s12249-018-1059-3
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- Publication type:
- Article
Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report.
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- AAPS Journal, 2018, v. 20, n. 3, p. 1, doi. 10.1208/s12248-018-0213-x
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- Publication type:
- Article
Single‐ and Multiple‐Dose Pharmacokinetics of Once‐Daily Formulations of Raltegravir.
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- Clinical Pharmacology in Drug Development, 2018, v. 7, n. 2, p. 196, doi. 10.1002/cpdd.358
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- Publication type:
- Article
Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms.
- Published in:
- AAPS Journal, 2017, v. 19, n. 6, p. 1537, doi. 10.1208/s12248-017-0117-1
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- Article
Evolution of Choice of Solubility and Dissolution Media After Two Decades of Biopharmaceutical Classification System.
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- AAPS Journal, 2017, v. 19, n. 4, p. 989, doi. 10.1208/s12248-017-0085-5
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- Article
Comparing Dog and Human Intestinal Fluids: Implications on Solubility and Biopharmaceutical Risk Assessment.
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- AAPS PharmSciTech, 2017, v. 18, n. 4, p. 1408, doi. 10.1208/s12249-016-0611-2
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- Article
Coadministration of Rifampin Significantly Reduces Odanacatib Concentrations in Healthy Subjects.
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- Journal of Clinical Pharmacology, 2017, v. 57, n. 1, p. 110, doi. 10.1002/jcph.780
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- Publication type:
- Article
Characteristics of the Human Upper Gastrointestinal Contents in the Fasted State Under Hypo- and A-chlorhydric Gastric Conditions Under Conditions of Typical Drug - Drug Interaction Studies.
- Published in:
- Pharmaceutical Research, 2016, v. 33, n. 6, p. 1399, doi. 10.1007/s11095-016-1882-8
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- Publication type:
- Article
Comparison of Deconvolution-Based and Absorption Modeling IVIVC for Extended Release Formulations of a BCS III Drug Development Candidate.
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- AAPS Journal, 2015, v. 17, n. 6, p. 1492, doi. 10.1208/s12248-015-9816-7
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- Publication type:
- Article
Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm.
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- AAPS Journal, 2015, v. 17, n. 5, p. 1224, doi. 10.1208/s12248-015-9781-1
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- Article
Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
- Published in:
- 2015
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- Publication type:
- Report
Development of a Novel Oral Cavity Compartmental Absorption and Transit Model for Sublingual Administration: Illustration with Zolpidem.
- Published in:
- AAPS Journal, 2015, v. 17, n. 3, p. 631, doi. 10.1208/s12248-015-9727-7
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- Publication type:
- Article
Application of Absorption Modeling to Predict Bioequivalence Outcome of Two Batches of Etoricoxib Tablets.
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- AAPS PharmSciTech, 2015, v. 16, n. 1, p. 76, doi. 10.1208/s12249-014-0194-8
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- Publication type:
- Article
Identification of key factors affecting the oral absorption of salts of lipophilic weak acids: a case example.
- Published in:
- Journal of Pharmacy & Pharmacology, 2015, v. 67, n. 1, p. 56, doi. 10.1111/jphp.12320
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- Article
Use of Preclinical Dog Studies and Absorption Modeling to Facilitate Late Stage Formulation Bridging for a BCS II Drug Candidate.
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- AAPS PharmSciTech, 2014, v. 15, n. 1, p. 20, doi. 10.1208/s12249-013-0030-6
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- Publication type:
- Article
Crystalline Nanosuspensions as Potential Toxicology and Clinical Oral Formulations for BCS II/IV Compounds.
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- AAPS Journal, 2012, v. 14, n. 4, p. 677, doi. 10.1208/s12248-012-9383-0
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- Publication type:
- Article
Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit.
- Published in:
- 2010
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- Publication type:
- Report
Understanding the Effect of API Properties on Bioavailability Through Absorption Modeling.
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- 2009
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- Publication type:
- Correction notice
Understanding the Effect of API Properties on Bioavailability Through Absorption Modeling.
- Published in:
- AAPS Journal, 2008, v. 10, n. 4, p. 516, doi. 10.1208/s12248-008-9061-4
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- Publication type:
- Article
Restituting intestinal epithelial cells exhibit increased transducibility by adenoviral vectors.
- Published in:
- Journal of Gene Medicine, 2006, v. 8, n. 12, p. 1379, doi. 10.1002/jgm.981
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- Publication type:
- Article