Works matching AU Younis, Islam R.

Results: 30

Pharmacokinetics and Safety of Cilofexor and Firsocostat in Healthy Japanese and Non‐Japanese Participants.

Published in:

Journal of Clinical Pharmacology, 2024, v. 64, n. 12, p. 1586, doi. 10.1002/jcph.6114

By:

Younis, Islam R.;
Nelson, Cara;
Weber, Elijah J.;
Shen, Gong;
Qin, Ann R.;
Xiao, Deqing;
Watkins, Timothy R.;
Othman, Ahmed A.

Publication type:

Article

Pharmacokinetics and Safety of Firsocostat, an Acetyl‐Coenzyme A Carboxylase Inhibitor, in Participants with Mild, Moderate, and Severe Hepatic Impairment.

Published in:

Journal of Clinical Pharmacology, 2024, v. 64, n. 7, p. 878, doi. 10.1002/jcph.2427

By:

Younis, Islam R.;
Nelson, Cara;
Weber, Elijah J.;
Qin, Ann R.;
Watkins, Timothy R.;
Othman, Ahmed A.

Publication type:

Article

Feasibility of Using Population Pharmacokinetics‐Based Virtual Control Groups in Organ Impairment Studies.

Published in:

Journal of Clinical Pharmacology, 2024, v. 64, n. 6, p. 713, doi. 10.1002/jcph.2410

By:

Younis, Islam R.;
Wang, Fan;
Othman, Ahmed A.

Publication type:

Article

Effect of Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist.

Published in:

Journal of Clinical Pharmacology, 2023, v. 63, n. 9, p. 1017, doi. 10.1002/jcph.2260

By:

Younis, Islam R.;
Hsueh, Chia‐Hsiang;
Nelson, Cara;
Billin, Andrew N.;
Yue, Mun Sang;
Xiao, Deqing;
Watkins, Timothy R.;
Othman, Ahmed A.

Publication type:

Article

Effect of Renal Impairment on the Pharmacokinetics of Firsocostat, an Acetyl‐Coenzyme A Carboxylase Inhibitor, and Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist.

Published in:

Journal of Clinical Pharmacology, 2023, v. 63, n. 5, p. 560, doi. 10.1002/jcph.2206

By:

Weber, Elijah;
Younis, Islam R.;
Nelson, Cara;
Ding, Dora;
Qin, Ann;
Xiao, Deqing;
Watkins, Timothy R.;
Othman, Ahmed A.

Publication type:

Article

Overview of Clinical Pharmacology Packages of New Drug Applications Approved for the Treatment of Rare Diseases.

Published in:

Journal of Clinical Pharmacology, 2022, v. 62, p. S72, doi. 10.1002/jcph.2167

By:

Qosa, Hisham;
Hassan, Hazem E.;
Younis, Islam R.

Publication type:

Article

Concordance of Exposure Changes Because of Renal Impairment Between Results of Dedicated Renal Impairment Studies and Population Pharmacokinetic Predictions.

Published in:

Journal of Clinical Pharmacology, 2021, v. 61, n. 10, p. 1324, doi. 10.1002/jcph.1907

By:

Ahmed, Mariam A.;
Kalaria, Shamir N.;
Younis, Islam R.

Publication type:

Article

Drug‐Drug Interaction Studies of Methadone and Antiviral Drugs: Lessons Learned.

Published in:

Journal of Clinical Pharmacology, 2019, v. 59, n. 8, p. 1035, doi. 10.1002/jcph.1405

By:

Younis, Islam R.;
Lakota, Elizabeth A.;
Volpe, Donna A.;
Patel, Vikram;
Xu, Yun;
Sahajwalla, Chandra G.

Publication type:

Article

Treatment and Prevention of CMV Disease in Transplant Recipients: Current Knowledge and Future Perspectives.

Published in:

Journal of Clinical Pharmacology, 2019, v. 59, n. 6, p. 784, doi. 10.1002/jcph.1363

By:

Hodowanec, Aimee C.;
Pikis, Andreas;
Komatsu, Takashi E.;
Sampson, Mario R.;
Younis, Islam R.;
O'Rear, Julian J.;
Singer, Mary E.

Publication type:

Article

Dosing Recommendations for Quetiapine When Coadministered With HIV Protease Inhibitors.

Published in:

Journal of Clinical Pharmacology, 2019, v. 59, n. 4, p. 500, doi. 10.1002/jcph.1345

By:

Sampson, Mario R.;
Cao, Kelly Y.;
Gish, Paula L.;
Hyon, Kyong;
Mishra, Poonam;
Tauber, William;
Zhao, Ping;
Zhou, Esther H.;
Younis, Islam R.

Publication type:

Article

Stable Isotope Pharmacokinetic Studies Provide Insight into Effects of Age, Sex, and Weight on Levothyroxine Metabolism.

Published in:

Thyroid, 2018, v. 28, n. 1, p. 41, doi. 10.1089/thy.2017.0380

By:

Younis, Islam R.;
Ahmed, Mariam A.;
Burman, Kenneth D.;
Soldin, Offie P.;
Jonklaas, Jacqueline

Publication type:

Article

Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications.

Published in:

2020

By:

Younis, Islam R.;
Gopalakrishnan, Mathangi;
Mathis, Mitchell;
Mehta, Mehul;
Uppoor, Ramana;
Zhu, Hao;
Farchione, Tiffany

Publication type:

journal article

Effects of Tobacco Smoking and Nicotine on Cancer Treatment.

Published in:

Pharmacotherapy, 2012, v. 32, n. 10, p. 920, doi. 10.1002/j.1875-9114.2012.01117

By:

Petros, William P.;
Younis, Islam R.;
Ford, James N.;
Weed, Scott A.

Publication type:

Article

Enterohepatic recirculation model of irinotecan (CPT-11) and metabolite pharmacokinetics in patients with glioma.

Published in:

Cancer Chemotherapy & Pharmacology, 2009, v. 63, n. 3, p. 517, doi. 10.1007/s00280-008-0769-8

By:

Younis, Islam R.;
Malone, Samuel;
Friedman, Henry S.;
Schaaf, Larry J.;
Petros, William P.

Publication type:

Article

Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop.

Published in:

Journal of Clinical Pharmacology, 2017, v. 57, n. 1, p. 105, doi. 10.1002/jcph.787

By:

Younis, Islam R.;
Robert Powell, J.;
Rostami‐Hodjegan, Amin;
Corrigan, Brian;
Stockbridge, Norman;
Sinha, Vikram;
Zhao, Ping;
Jadhav, Pravin;
Flamion, Bruno;
Cook, Jack

Publication type:

Article

Design Features of Drug-Drug Interaction Trials Between Antivirals and Oral Contraceptives.

Published in:

Journal of Clinical Pharmacology, 2016, v. 56, n. 5, p. 541, doi. 10.1002/jcph.637

By:

Ayala, Ruben C.;
Arya, Vikram;
Younis, Islam R.

Publication type:

Article

An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: Review of recent cases in psychiatry drugs.

Published in:

Journal of Clinical Pharmacology, 2013, v. 53, n. 10, p. 1005, doi. 10.1002/jcph.118

By:

Younis, Islam R.;
Rogers, Hobart;
Zhang, Huixia;
Zhu, Hao;
Uppoor, Ramana S.;
Mehta, Mehul U.

Publication type:

Article

Evaluation of the Effects of Meal Type and Acid‐Reducing Agents on the Pharmacokinetics of Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 6, p. 677, doi. 10.1002/cpdd.1384

By:

Weber, Elijah J.;
Younis, Islam R.;
Wang, Lulu;
Xiao, Deqing;
Barchuk, William T.;
Othman, Ahmed A.

Publication type:

Article

Pharmacokinetics, pharmacodynamics, safety and tolerability of cilofexor, a novel nonsteroidal Farnesoid X receptor agonist, in healthy volunteers.

Published in:

CTS: Clinical & Translational Science, 2023, v. 16, n. 3, p. 536, doi. 10.1111/cts.13469

By:

Younis, Islam R.;
Kirby, Brian J.;
Billin, Andrew N.;
Xiao, Deqing;
Song, Qinghua;
Watkins, Timothy R.;
Othman, Ahmed A.

Publication type:

Article

Glutathione conjugation of busulfan produces a hydroxyl radical-trapping dehydroalanine metabolite.

Published in:

Xenobiotica, 2012, v. 42, n. 12, p. 1170, doi. 10.3109/00498254.2012.696740

By:

Peer, Cody J.;
Younis, Islam R.;
Leonard, Stephen S.;
Gannett, Peter M.;
Minarchick, Valerie C.;
Kenyon, Allison J.;
Rojanasakul, Yon;
Callery, Patrick S.

Publication type:

Article

Opportunities and Challenges of Hepatic Impairment Physiologically Based Pharmacokinetic Modeling in Drug Development—An IQ Perspective.

Published in:

Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 6, p. 1682, doi. 10.1002/cpt.3601

By:

Qosa, Hisham;
Younis, Islam R.;
Sahasrabudhe, Vaishali;
Sharma, Ashish;
Yan, Jin;
Galluppi, Gerald;
Posada, Maria M.;
Kanodia, Jitendra Shrawan

Publication type:

Article

An IQ Industry Perspective on Informing Dosing Recommendations in Patients With Renal Impairment.

Published in:

Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 2, p. 337, doi. 10.1002/cpt.3463

By:

Sharma, Ashish;
Younis, Islam R.;
Kanodia, Jitendra;
Sahasrabudhe, Vaishali

Publication type:

Article

Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 6, p. 1412, doi. 10.1002/cpt.3407

By:

Ahmed, Mariam A.;
Krishna, Rajesh;
Rayad, Noha;
Albusaysi, Salwa;
Mitra, Amitava;
Shang, Elizabeth;
Hon, Yuen Yi;
AbuAsal, Bilal;
Bakhaidar, Rana;
Roman, Youssef M.;
Bhattacharya, Indranil;
Cloyd, James;
Patel, Munjal;
Kartha, Reena V.;
Younis, Islam R.

Publication type:

Article

New Horizons of Model Informed Drug Development in Rare Diseases Drug Development.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 6, p. 1398, doi. 10.1002/cpt.3366

By:

Mitra, Amitava;
Tania, Nessy;
Ahmed, Mariam A.;
Rayad, Noha;
Krishna, Rajesh;
Albusaysi, Salwa;
Bakhaidar, Rana;
Shang, Elizabeth;
Burian, Maria;
Martin‐Pozo, Michelle;
Younis, Islam R.

Publication type:

Article

Characterization of the US Food and Drug Administration Post‐Marketing Commitments and Requirements for Pregnancy and Lactation.

Published in:

Clinical Pharmacology & Therapeutics, 2023, v. 114, n. 6, p. 1238, doi. 10.1002/cpt.3059

By:

Avachat, Charul;
Younis, Islam R.;
Birnbaum, Angela K.

Publication type:

Article

Model‐Informed Approaches and Innovative Clinical Trial Design for Adeno‐Associated Viral Vector‐Based Gene Therapy Product Development: A White Paper.

Published in:

Clinical Pharmacology & Therapeutics, 2023, v. 114, n. 3, p. 515, doi. 10.1002/cpt.2972

By:

Mitra, Amitava;
Ahmed, Mariam A.;
Krishna, Rajesh;
Sun, Kefeng;
Gibbons, Francis D.;
Campagne, Olivia;
Rayad, Noha;
Roman, Youssef M.;
Albusaysi, Salwa;
Burian, Maria;
Younis, Islam R.

Publication type:

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

By:

Shugg, Tyler;
Powell, Nicholas R.;
Marroum, Patrick J.;
Skaar, Todd C.;
Younis, Islam R.

Publication type:

Article

Trends in FDA Transporter‐Based Post‐Marketing Requirements and Commitments Over the Last Decade.

Published in:

Clinical Pharmacology & Therapeutics, 2022, v. 112, n. 3, p. 635, doi. 10.1002/cpt.2701

By:

Younis, Islam R.;
Manchandani, Pooja;
Hassan, Hazem E.;
Qosa, Hisham

Publication type:

Article

Evaluation of the Potential for Cytochrome P450 and Transporter-Mediated Drug–Drug Interactions for Firsocostat, a Liver-Targeted Inhibitor of Acetyl-CoA Carboxylase.

Published in:

Clinical Pharmacokinetics, 2024, v. 63, n. 10, p. 1423, doi. 10.1007/s40262-024-01420-0

By:

Weber, Elijah J.;
Younis, Islam R.;
Nelson, Cara;
Qin, Ann R.;
Watkins, Timothy R.;
Othman, Ahmed A.

Publication type:

Article

Phase I evaluation of gemcitabine, mitoxantrone, and their effect on plasma disposition of fludarabine in patients with relapsed or refractory acute myeloid leukemia.

Published in:

Leukemia & Lymphoma, 2008, v. 49, n. 8, p. 1523, doi. 10.1080/10428190802210700

By:

Rao, Arati V.;
Younis, Islam R.;
Sand, Gregory J.;
Spasojevic, Ivan;
Adams, David J.;
Decastro, Carlos M.;
Gockerman, John P.;
Peterson, Bercedis L.;
Petros, William P.;
Moore, Joseph O.;
Rizzieri, David A.

Publication type:

Article