1. 2344. FDA Analysis of CD4+ Cell Count Declines Observed in HIV-Infected Children Treated With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. (26th November 2018) Authors: Bell, Tanvir; Baylor, Melisse; Rhee, Sung; Tracy, LaRee; Sampson, Mario; Younis, Islam; Belew, Yodit; Carter, Wendy; Viswanathan, Prabha Journal: Open forum infectious diseases Issue: Volume 5(2018)Supplement 1 Page Start: S697 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. A Quantitative Justification of Similarity in Placebo Response Between Adults and Adolescents With Acute Exacerbation of Schizophrenia in Clinical Trials. Issue 5 (3rd July 2019) Authors: Kalaria, Shamir N.; Zhu, Hao; Farchione, Tiffany R.; Mathis, Mitchell V.; Gopalakrishnan, Mathangi; Uppoor, Ramana; Mehta, Mehul; Younis, Islam Journal: Clinical pharmacology & therapeutics Issue: Volume 106:Issue 5(2019) Page Start: 1046 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Adverse Event Detection and Labeling in Pediatric Drug Development: Antiretroviral Drugs. (March 2015) Authors: Momper, Jeremiah D.; Chang, Yang; Jackson, Matthew; Schuette, Paul; Seo, Shirley; Younis, Islam; Abernethy, Darrell R.; Yao, Lynne; Capparelli, Edmund V.; Burckart, Gilbert J. Journal: Therapeutic innovation & regulatory science Issue: Volume 49:Number 2(2015:Mar.) Page Start: 302 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. Assessment of Hepatic Impairment and Implications for Pharmacokinetics of Substance Use Treatment. Issue 2 (March 2017) Authors: Talal, Andrew H.; Venuto, Charles S.; Younis, Islam Journal: Clinical pharmacology in drug development Issue: Volume 6:Issue 2(2017) Page Start: 206 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. Assessment of Similarity in Antipsychotic Exposure‐Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia. (28th January 2020) Authors: Kalaria, Shamir N.; Farchione, Tiffany R.; Mathis, Mitchell V.; Gopalakrishnan, Mathangi; Younis, Islam; Uppoor, Ramana; Mehta, Mehul; Wang, Yaning; Zhu, Hao Journal: Journal of clinical pharmacology Issue: Volume 60:Number 7(2020) Page Start: 848 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. ASSOCIATION BETWEEN ANTIBIOTIC USE AND INFLAMMATORY BOWEL DISEASE OUTCOMES. (26th January 2023) Authors: Liu, Luke; O'Charoen, Sirimon; Fehlmann, Tara; Roedder, Silke; Wendt, Emily; Billin, Andrew; Younis, Islam; Iqbal, Shahed Journal: Inflammatory bowel diseases Issue: Volume 29(2023)Supplement 1 Page Start: S33 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Design and conduct considerations for studies in patients with hepatic impairment. Issue 1 (9th October 2022) Authors: Ravenstijn, Paulien; Chetty, Manoranjenni; Manchandani, Pooja; Elmeliegy, Mohamed; Qosa, Hisham; Younis, Islam Journal: Clinical and translational science Issue: Volume 16:Issue 1(2023) Page Start: 50 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. Science and Evidence‐Based Review and Approval of COVID‐19 Vaccines: A Statement of Support for the US FDA. (27th January 2021) Authors: Pai, Sudhakar M.; Othman, Ahmed A.; Rusch, Lorraine; Masters, Joanna C.; Greene, Douglas; Rogge, Mark; Gries, Jean‐Michel; Clementi, William; Kumar, Parag; Younis, Islam; Salem, Ahmed Hamed; Gaynes, Bruce I.; Pastino, Gina; Derendorf, Hartmut Journal: Journal of clinical pharmacology Issue: Volume 61:Number 3(2021) Page Start: 277 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. Shortened Positive and Negative Symptom Scale as an Alternate Clinical Endpoint for Acute Schizophrenia Trials: Analysis from the US Food & Drug Administration. Issue 1 (6th November 2020) Authors: Gopalakrishnan, Mathangi; Farchione, Tiffany; Mathis, Mitchell; Zhu, Hao; Mehta, Mehul; Uppoor, Ramana; Younis, Islam Journal: Psychiatric Research and Clinical Practice Issue: Volume 3:Issue 1(2021) Page Start: 38 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. Time to Rethink the Current Paradigm for Assessing Kidney Function in Drug Development and Beyond. Issue 5 (18th December 2021) Authors: Sharma, Ashish; Sahasrabudhe, Vaishali; Musib, Luna; Zhang, Steven; Younis, Islam; Kanodia, Jitendra Journal: Clinical pharmacology & therapeutics Issue: Volume 112:Issue 5(2022) Page Start: 946 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗