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Page 1
Review of Clinical Pharmacology Information for Peptides Found in US FDA Drug Labeling.
Naik R, Wang J, Zhou L, Balakrishnan A, Florian J, Madabushi R, Maxfield K, Ramamoorthy A, Sahre M, Wang YM, Yang X, Pfuma Fletcher E. Naik R, et al. Among authors: yang x. J Clin Pharmacol. 2025 Nov;65(11):1370-1380. doi: 10.1002/jcph.70047. Epub 2025 Jun 4. J Clin Pharmacol. 2025. PMID: 40464664 Review.
To inform best practices in clinical pharmacology, we reviewed general characteristics of peptides approved by US Food and Drug Administration before July 2022 and how often clinical pharmacology information, and corresponding recommendations were discussed i …
To inform best practices in clinical pharmacology, we reviewed general characteristics of peptides approved by US Food and Drug …
Identification and Clinical Evaluation of Potential Biomarkers for Breast Cancer Resistance Protein (BCRP/ABCG2).
Riselli AM, Yee SW, Yang J, Brett CM, Trumbach K, Zhou X, Liu R, Liang X, Lai Y, Huo R, Xue Y, Shen H, Zhang L, Yang X, Liu Q, Huang SM, Giacomini KM. Riselli AM, et al. Among authors: yang x. Clin Pharmacol Ther. 2025 Jul;118(1):177-189. doi: 10.1002/cpt.3657. Epub 2025 Apr 1. Clin Pharmacol Ther. 2025. PMID: 40170495 Free PMC article.
Clinical inhibition and genetic variation of the Breast Cancer Resistance Protein (BCRP/ABCG2) efflux transporter can significantly influence drug exposure, highlighting the need for reliable BCRP functional biomarkers. This study aimed to identify and evaluate biomarkers …
Clinical inhibition and genetic variation of the Breast Cancer Resistance Protein (BCRP/ABCG2) efflux transporter can significantly influenc …
Novel (Q)SAR models for prediction of reversible and time-dependent inhibition of cytochrome P450 enzymes.
Faramarzi S, Bassan A, Cross KP, Yang X, Myatt GJ, Volpe DA, Stavitskaya L. Faramarzi S, et al. Among authors: yang x. Front Pharmacol. 2025 Feb 12;15:1451164. doi: 10.3389/fphar.2024.1451164. eCollection 2024. Front Pharmacol. 2025. PMID: 40012840 Free PMC article.
The 2020 FDA drug-drug interaction (DDI) guidance includes a consideration for metabolites with structural alerts for potential mechanism-based inhibition (MBI) and describes how this information may be used to determine whether in vitro studies need to be co …
The 2020 FDA drug-drug interaction (DDI) guidance includes a consideration for metabolites with structural alerts for p …
Addressing Drug-Drug Interaction Knowledge Gaps at the Time of Approval: An Analysis of FDA Postmarketing Requirements and Commitments from 2009 to 2023.
Ridge S, Yang X, Madabushi R, Ramamoorthy A. Ridge S, et al. Among authors: yang x. J Clin Pharmacol. 2025 Mar;65(3):378-388. doi: 10.1002/jcph.6142. Epub 2024 Oct 3. J Clin Pharmacol. 2025. PMID: 39363538
The US Food and Drug Administration can establish postmarketing requirements (PMRs) or postmarketing commitments (PMCs) to address these knowledge gaps. ...The 89% of PMRs and PMCs that were considered fulfilled had a revision to the United States …
The US Food and Drug Administration can establish postmarketing requirements (PMRs) or postmarketing commitments (PMCs) …
Statin Drug-Drug Interactions: Pharmacokinetic Basis of FDA Labeling Recommendations and Comparison Across Common Tertiary Clinical Resources.
Mease J, Ramamoorthy A, Yang X, Madabushi R, Pfuma Fletcher E, Zineh I. Mease J, et al. Among authors: yang x. J Clin Pharmacol. 2024 Jun;64(6):704-712. doi: 10.1002/jcph.2406. Epub 2024 Feb 1. J Clin Pharmacol. 2024. PMID: 38299698
Statins are widely prescribed and highly susceptible to pharmacokinetic (PK)-based drug-drug interactions (DDIs). To date, there has not been a comprehensive analysis of the basis upon which statin DDI recommendations in US Food and Drug Administrat …
Statins are widely prescribed and highly susceptible to pharmacokinetic (PK)-based drug-drug interactions (DDIs). To date, the …
Membrane transporters in drug development and as determinants of precision medicine.
Galetin A, Brouwer KLR, Tweedie D, Yoshida K, Sjöstedt N, Aleksunes L, Chu X, Evers R, Hafey MJ, Lai Y, Matsson P, Riselli A, Shen H, Sparreboom A, Varma MVS, Yang J, Yang X, Yee SW, Zamek-Gliszczynski MJ, Zhang L, Giacomini KM. Galetin A, et al. Among authors: yang x. Nat Rev Drug Discov. 2024 Apr;23(4):255-280. doi: 10.1038/s41573-023-00877-1. Epub 2024 Jan 24. Nat Rev Drug Discov. 2024. PMID: 38267543 Free PMC article. Review.
The effect of membrane transporters on drug disposition, efficacy and safety is now well recognized. Since the initial publication from the International Transporter Consortium, significant progress has been made in understanding the roles and functions of transporters, as …
The effect of membrane transporters on drug disposition, efficacy and safety is now well recognized. Since the initial publication fr …
Combined Oral Contraceptives As Victims of Drug Interactions.
Li L, Yang X, Tran D, Seo SK, Lu Y. Li L, et al. Among authors: yang x. Drug Metab Dispos. 2023 Jun;51(6):718-732. doi: 10.1124/dmd.122.000854. Epub 2023 Mar 24. Drug Metab Dispos. 2023. PMID: 36963837 Free PMC article. Review.
Combined oral contraceptives (COCs) are widely used in women of reproductive age in the United States. Metabolism plays an important role in the elimination of estrogens and progestins contained in COCs. ...Therefore, for an investigational drug intended to b …
Combined oral contraceptives (COCs) are widely used in women of reproductive age in the United States. Metabolism plays an imp …
Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non-orphan drugs approved by the FDA.
Hsieh J, Sahre M, Yang X, Madabushi R, Ramamoorthy A. Hsieh J, et al. Among authors: yang x. Clin Transl Sci. 2022 Nov;15(11):2583-2596. doi: 10.1111/cts.13362. Epub 2022 Sep 27. Clin Transl Sci. 2022. PMID: 36165094 Free PMC article.
A total of 151 NMEs, including 72 orphan and 79 non-orphan drugs, were analyzed for recommendations and information available related to food-drug interaction, drug-drug interaction, renal impairment, hepatic impairment, QT assessment, and human radiol …
A total of 151 NMEs, including 72 orphan and 79 non-orphan drugs, were analyzed for recommendations and information available related to …
Clinical Relevance of Hepatic and Renal P-gp/BCRP Inhibition of Drugs: An International Transporter Consortium Perspective.
Taskar KS, Yang X, Neuhoff S, Patel M, Yoshida K, Paine MF, Brouwer KLR, Chu X, Sugiyama Y, Cook J, Polli JW, Hanna I, Lai Y, Zamek-Gliszczynski M; ITC. Taskar KS, et al. Among authors: yang x. Clin Pharmacol Ther. 2022 Sep;112(3):573-592. doi: 10.1002/cpt.2670. Epub 2022 Jun 22. Clin Pharmacol Ther. 2022. PMID: 35612761 Free PMC article. Review.
The role of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in drug-drug interactions (DDIs) and limiting drug absorption as well as restricting the brain penetration of drugs with certain physicochemical properties is well known. ...This IT …
The role of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in drug-drug interactions (DDIs) and limiting …
Application of Solubility and Dissolution Profile Comparison for Prediction of Gastric pH-Mediated Drug-Drug Interactions.
Miao L, Wu F, Yang X, Mousa YM, Ramamoorthy A, Lee SC, Raines K, Zhang L, Seo P. Miao L, et al. Among authors: yang x. AAPS J. 2022 Feb 14;24(1):35. doi: 10.1208/s12248-022-00684-3. AAPS J. 2022. PMID: 35165814
The objective of this study was to assess how solubility and dissolution profile comparisons under different pH conditions can be used to predict gastric pH-mediated drug-drug interaction (DDI) potential. We collected information for new molecular entities (NMEs) ap …
The objective of this study was to assess how solubility and dissolution profile comparisons under different pH conditions can be used to pr …
17 results