Islam R Younis (Islam Younis)

Publication Activity (10 Years)

Years Active: 2021-2024
Publications (10 Years): 16

Top Topics

Drug Administration

Top Venues

Journal of clinical pharmacology

Clinical pharmacology and therapeutics

This page only lists publications with an associated author ORCID identifier.

Publications

Islam R Younis, Cara Nelson, Elijah J Weber, Gong Shen, Ann R Qin, Deqing Xiao, Timothy R Watkins, Ahmed A Othman
Pharmacokinetics and Safety of Cilofexor and Firsocostat in Healthy Japanese and Non-Japanese Participants. Journal of clinical pharmacology (2024)
Islam R Younis, Cara Nelson, Elijah J Weber, Ann R Qin, Timothy R Watkins, Ahmed A Othman
Pharmacokinetics and Safety of Firsocostat, an Acetyl-Coenzyme A Carboxylase Inhibitor, in Participants with Mild, Moderate, and Severe Hepatic Impairment. Journal of clinical pharmacology 64 (7) (2024)
Mariam A Ahmed, Rajesh Krishna, Noha Rayad, Salwa Albusaysi, Amitava Mitra, Elizabeth Shang, Yuen Yi Hon, Bilal Abuasal, Rana Bakur Bakhaidar, Youssef M Roman, Indranil Bhattacharya, James C Cloyd, Munjal Patel, Reena V Kartha, Islam R Younis
Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers. Clinical pharmacology and therapeutics (2024)
Islam R Younis, Fan Wang, Ahmed A Othman
Feasibility of Using Population Pharmacokinetics-Based Virtual Control Groups in Organ Impairment Studies. Journal of clinical pharmacology (2024)
Amitava Mitra, Nessy Tania, Mariam A Ahmed, Noha Rayad, Rajesh Krishna, Salwa Albusaysi, Rana Bakur Bakhaidar, Elizabeth Shang, Maria Burian, Michelle Martin-Pozo, Islam R Younis
New Horizons of Model Informed Drug Development in Rare Diseases Drug Development. Clinical pharmacology and therapeutics (2024)
Islam R Younis, Cara Nelson, Elijah J Weber, Ann R Qin, Timothy R Watkins, Ahmed A Othman
Pharmacokinetics and Safety of Firsocostat, an Acetyl-Coenzyme A Carboxylase Inhibitor, in Participants with Mild, Moderate, and Severe Hepatic Impairment. Journal of clinical pharmacology (2024)
Islam R Younis, Cara Nelson, Elijah J Weber, Ann R Qin, Timothy R Watkins, Ahmed A Othman
Pharmacokinetics and Safety of Firsocostat, an Acetyl-Coenzyme A Carboxylase Inhibitor, in Participants with Mild, Moderate, and Severe Hepatic Impairment. Journal of clinical pharmacology 64 (7) (2024)
Islam R Younis, Fan Wang, Ahmed A Othman
Feasibility of Using Population Pharmacokinetics-Based Virtual Control Groups in Organ Impairment Studies. Journal of clinical pharmacology 64 (6) (2024)
Rui Zhu, Bianca Vora, Sujatha Menon, Islam R Younis, Gaurav Dwivedi, Zhaoling Meng, Amita Datta-Mannan, Pooja Manchandani, Satyaprakash Nayak, Brinda K Tammara, Parag Garhyan, Shahed Iqbal, Simon Dagenais, Pascal Chanu, Arnab Mukherjee, Cyrus Ghobadi, null null
Clinical Pharmacology Applications of Real-World Data and Real-World Evidence in Drug Development and Approval- An Industry Perspective. Clinical pharmacology and therapeutics (2023)
Charul Avachat, Islam R Younis, Angela K Birnbaum
Characterization of the US Food and Drug Administration Post-Marketing Commitments and Requirements for Pregnancy and Lactation. Clinical pharmacology and therapeutics (2023)
Amitava Mitra, Mariam A Ahmed, Rajesh Krishna, Kefeng Sun, Francis D Gibbons, Olivia Campagne, Noha Rayad, Youssef M Roman, Salwa Albusaysi, Maria Burian, Islam R Younis
Model-Informed Approaches and Innovative Clinical Trial Design for Adeno-Associated Viral Vector-based Gene Therapy Product Development - A White Paper. Clinical pharmacology and therapeutics (2023)
Hisham Qosa, Hazem E Hassan, Islam R Younis
Overview of Clinical Pharmacology Packages of New Drug Applications Approved for the Treatment of Rare Diseases. Journal of clinical pharmacology (2022)
Tyler Shugg, Nicholas R Powell, Patrick J Marroum, Todd C Skaar, Islam R Younis
Evaluation of US Food and Drug Administration Drug Label Recommendations for Coadministration of Antivirals and Acid-Reducing Agents. Clinical pharmacology and therapeutics 112 (5) (2022)
Kenneth Todd Moore, Michael J Fossler, Islam R Younis, null null
The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials. Journal of clinical pharmacology 62 (12) (2022)
Islam R Younis, Pooja Manchandani, Hazem E Hassan, Hisham Qosa
Trends in FDA Transporter-Based Post-Marketing Requirements and Commitments Over the Last Decade. Clinical pharmacology and therapeutics 112 (3) (2022)
Mariam A Ahmed, Shamir N Kalaria, Islam R Younis
Concordance of Exposure Changes Because of Renal Impairment Between Results of Dedicated Renal Impairment Studies and Population Pharmacokinetic Predictions. Journal of clinical pharmacology 61 (10) (2021)