Islam Younis
0000-0001-9000-0431
10 papers found
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Pharmacokinetics and Safety of Firsocostat, an Acetyl‐Coenzyme A Carboxylase Inhibitor, in Participants with Mild, Moderate, and Severe Hepatic Impairment
Feasibility of Using Population Pharmacokinetics‐Based Virtual Control Groups in Organ Impairment Studies
Characterization of the US Food and Drug Administration Post‐Marketing Commitments and Requirements for Pregnancy and Lactation
Clinical Pharmacology Applications of Real‐World Data and Real‐World Evidence in Drug Development and Approval–An Industry Perspective
Model‐Informed Approaches and Innovative Clinical Trial Design for Adeno‐Associated Viral Vector‐Based Gene Therapy Product Development: A White Paper
Overview of Clinical Pharmacology Packages of New Drug Applications Approved for the Treatment of Rare Diseases
The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials
Evaluation of US Food and Drug Administration Drug Label Recommendations for Coadministration of Antivirals and Acid‐Reducing Agents
Trends in FDA Transporter‐Based Post‐Marketing Requirements and Commitments Over the Last Decade
Concordance of Exposure Changes Because of Renal Impairment Between Results of Dedicated Renal Impairment Studies and Population Pharmacokinetic Predictions
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