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Drug–Drug Interaction Studies: Regulatory Guidance and An Industry Perspective

The AAPS journal, 2013-07, Vol.15 (3), p.629-645

2013

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Assessing the relative contribution of CYP3A-and P-gp-mediated pathways to the overall disposition and drug-drug interaction of dabigatran etexilate using a comprehensive mechanistic physiological-based pharmacokinetic model

Frontiers in pharmacology, 2024-03, Vol.15, p.1356273-1356273

2024

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Impact of methionine oxidation in human IgG1 Fc on serum half-life of monoclonal antibodies

Molecular immunology, 2011-03, Vol.48 (6-7), p.860-866

2011

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Pitavastatin is a more sensitive and selective organic anion‐transporting polypeptide 1B clinical probe than rosuvastatin

British journal of clinical pharmacology, 2014-09, Vol.78 (3), p.587-598

2014

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Use of In Vivo Animal Models to Assess Pharmacokinetic Drug-Drug Interactions

Pharmaceutical research, 2010-09, Vol.27 (9), p.1772-1787

2010

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Quantification of CYP3A and Drug Transporters Activity in Healthy Young, Healthy Elderly and Chronic Kidney Disease Elderly Patients by a Microdose Cocktail Approach

Frontiers in pharmacology, 2021-09, Vol.12, p.726669-726669

2021

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The effect of the neonatal Fc receptor on human IgG biodistribution in mice

mAbs, 2014-03, Vol.6 (2), p.502-508

2014

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Effects of fibrates on metabolism of statins in human hepatocytes

Drug metabolism and disposition, 2002-11, Vol.30 (11), p.1280

2002

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1371 Novel orally active and high tissue penetrant small molecules targeting surface and intracellular PD-L1 signals for cancer immunotherapy

Journal for immunotherapy of cancer, 2023-11, Vol.11 (Suppl 1), p.A1527-A1527

2023

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Glucuronidation of statins in animals and humans: a novel mechanism of statin lactonization

Drug metabolism and disposition, 2002-05, Vol.30 (5), p.505

2002

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Mechanistic studies on metabolic interactions between gemfibrozil and statins

The Journal of pharmacology and experimental therapeutics, 2002-06, Vol.301 (3), p.1042

2002

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Discovery of MK-3697: A selective orexin 2 receptor antagonist (2-SORA) for the treatment of insomnia

Bioorganic & medicinal chemistry letters, 2014-10, Vol.24 (20), p.4884-4890

2014

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Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites

Toxicology and applied pharmacology, 2006-12, Vol.217 (2), p.143-152

2006

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An allosteric Akt inhibitor effectively blocks Akt signaling and tumor growth with only transient effects on glucose and insulin levels in vivo

Cancer biology & therapy, 2010-04, Vol.9 (7), p.493-503

2010

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ADME of Biologics—What Have We Learned from Small Molecules?

The AAPS journal, 2012-09, Vol.14 (3), p.410-419

2012

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Discovery of 2,5-diarylnicotinamides as selective orexin-2 receptor antagonists (2-SORAs)

Bioorganic & medicinal chemistry letters, 2013-12, Vol.23 (24), p.6620-6624

2013

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Drug interactions with calcium channel blockers: possible involvement of metabolite-intermediate complexation with CYP3A

Drug metabolism and disposition, 2000-02, Vol.28 (2), p.125

2000

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Preclinical characterization of a novel potent core protein assembly modulator for the treatment of chronic hepatitis B viral infection

European journal of pharmaceutical sciences, 2024-09, Vol.200, p.106834, Article 106834

2024

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Prediction of human clearance of therapeutic proteins: simple allometric scaling method revisited

Biopharmaceutics & drug disposition, 2010-05, Vol.31 (4), p.253-263

2010

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Comparative effects of fibrates on drug metabolizing enzymes in human hepatocytes

Pharmaceutical research, 2005-01, Vol.22 (1), p.71-78

2005

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Theoretical Analysis of Interplay of Therapeutic Protein Drug and Circulating Soluble Target: Temporal Profiles of ‘Free’ and ‘Total’ Drug and Target

Pharmaceutical research, 2011-10, Vol.28 (10), p.2447-2457

2011

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Drug–Drug Interactions Related to Altered Absorption and Plasma Protein Binding: Theoretical and Regulatory Considerations, and an Industry Perspective

Journal of pharmaceutical sciences, 2015-03, Vol.104 (3), p.916-929

2015

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Drug–Drug Interaction Studies: Regulatory Guidance and An Industry Perspective

Assessing the relative contribution of CYP3A-and P-gp-mediated pathways to the overall disposition and drug-drug interaction of dabigatran etexilate using a comprehensive mechanistic physiological-based pharmacokinetic model

Impact of methionine oxidation in human IgG1 Fc on serum half-life of monoclonal antibodies

Pitavastatin is a more sensitive and selective organic anion‐transporting polypeptide 1B clinical probe than rosuvastatin

Use of In Vivo Animal Models to Assess Pharmacokinetic Drug-Drug Interactions

Discovery of the Dual Orexin Receptor Antagonist [(7R)-4-(5-Chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone (MK-4305) for the Treatment of Insomnia

Quantification of CYP3A and Drug Transporters Activity in Healthy Young, Healthy Elderly and Chronic Kidney Disease Elderly Patients by a Microdose Cocktail Approach

The effect of the neonatal Fc receptor on human IgG biodistribution in mice

Effects of fibrates on metabolism of statins in human hepatocytes

1371 Novel orally active and high tissue penetrant small molecules targeting surface and intracellular PD-L1 signals for cancer immunotherapy

Glucuronidation of statins in animals and humans: a novel mechanism of statin lactonization

Discovery of 5′′-Chloro-N-[(5,6-dimethoxypyridin-2-yl)methyl]-2,2′:5′,3′′-terpyridine-3′-carboxamide (MK-1064): A Selective Orexin 2 Receptor Antagonist (2-SORA) for the Treatment of Insomnia

Mechanistic studies on metabolic interactions between gemfibrozil and statins

Discovery of MK-3697: A selective orexin 2 receptor antagonist (2-SORA) for the treatment of insomnia

Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites

An allosteric Akt inhibitor effectively blocks Akt signaling and tumor growth with only transient effects on glucose and insulin levels in vivo

ADME of Biologics—What Have We Learned from Small Molecules?

Discovery of 2,5-diarylnicotinamides as selective orexin-2 receptor antagonists (2-SORAs)

Discovery of the Selective Androgen Receptor Modulator MK-0773 Using a Rational Development Strategy Based on Differential Transcriptional Requirements for Androgenic Anabolism Versus Reproductive Physiology

Drug interactions with calcium channel blockers: possible involvement of metabolite-intermediate complexation with CYP3A

Preclinical characterization of a novel potent core protein assembly modulator for the treatment of chronic hepatitis B viral infection

Prediction of human clearance of therapeutic proteins: simple allometric scaling method revisited

Comparative effects of fibrates on drug metabolizing enzymes in human hepatocytes

Theoretical Analysis of Interplay of Therapeutic Protein Drug and Circulating Soluble Target: Temporal Profiles of ‘Free’ and ‘Total’ Drug and Target

Drug–Drug Interactions Related to Altered Absorption and Plasma Protein Binding: Theoretical and Regulatory Considerations, and an Industry Perspective

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