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Advances in quantitative methods and modeling for complex generic drugs and opportunities to hybridize learnings between innovator and generic drug developers.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 549, doi. 10.1002/psp4.12968
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- Article
Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 631, doi. 10.1002/psp4.12952
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- Article
PBPK modeling of ivermectin—Considerations for the purpose of developing alternative routes to optimize its safety profile.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 598, doi. 10.1002/psp4.12950
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Physiologically based pharmacokinetic modeling of tacrolimus for food–drug and CYP3A drug–drug–gene interaction predictions.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 724, doi. 10.1002/psp4.12946
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Population pharmacokinetic modeling and simulation of maribavir to support dose selection and regulatory approval in adolescents with posttransplant refractory cytomegalovirus.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 719, doi. 10.1002/psp4.12943
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Relationship between factor VIII levels and bleeding for rFVIII‐SingleChain in severe hemophilia A: A repeated time‐to‐event analysis.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 706, doi. 10.1002/psp4.12938
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Cell‐level systems biology model to study inflammatory bowel diseases and their treatment options.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 690, doi. 10.1002/psp4.12932
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Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 624, doi. 10.1002/psp4.12931
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Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 552, doi. 10.1002/psp4.12930
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Biased computation of probability of target attainment for antimicrobial drugs.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 681, doi. 10.1002/psp4.12929
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The quest for balance between capturing data and model complexity: A quantitative clinical pharmacology approach applied to monoclonal antibodies.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 639, doi. 10.1002/psp4.12927
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Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 619, doi. 10.1002/psp4.12920
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Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 610, doi. 10.1002/psp4.12913
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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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Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 556, doi. 10.1002/psp4.12906
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Minimal physiologically‐based hybrid model of pharmacokinetics in pregnant women: Application to antenatal corticosteroids.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 668, doi. 10.1002/psp4.12899
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Mechanistic modeling of drug products applied to the skin: A workshop summary report.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 575, doi. 10.1002/psp4.12893
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- Article
Interplay among malnutrition, chemoprevention, and the risk of malaria in young Ugandan children: Longitudinal pharmacodynamic and growth analysis.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 656, doi. 10.1002/psp4.12892
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Issue Information.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 545, doi. 10.1002/psp4.12820
- Publication type:
- Article
Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 560, doi. 10.1002/psp4.12889
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- Article