1. [P4–014]: THE COALITION AGAINST MAJOR DISEASES: TOWARD U.S. FDA QUALIFICATION OF HIPPOCAMPAL VOLUME AS A BIOMARKER FOR ENRICHMENT IN CLINICAL TRIALS FOR PRE‐DEMENTIA STAGES OF ALZHEIMER'S DISEASE. (1st July 2017) Authors: Conrado, Daniela J.; Romero, Klaus; Corrigan, Brian; Ito, Kaori; Nicholas, Timothy; Chen, Danny; Samtani, Mahesh N.; Stone, Julie; Sinha, Vikram; Willis, Brian A.; Kern, Volker D.; Hill, Derek L.; Cole, Patricia E.; Novak, Gerald P.; Meibach, Richard; Matthews, Dawn C.; Schwarz, Adam J.; Xie, Zhi... Journal: Alzheimer's & dementia Issue: Volume 13:Supplement 7S(2017)Part 26 Page Start: P1259 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. Bridging Efficacy of Tofacitinib Immediate‐Release to Extended‐Release Formulations for Treatment of Ulcerative Colitis: Application of a Model‐Informed Drug Development Approach. Issue 8 (13th May 2022) Authors: Mukherjee, Arnab; Tsuchiwata, Shinichi; Chang, Cheng; Nicholas, Timothy; Su, Chinyu; Le, Vu H.; Kushner, Joseph; Kulisek, Nicole Journal: Clinical pharmacology in drug development Issue: Volume 11:Issue 8(2022) Page Start: 976 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Challenges in Alzheimer's Disease Drug Discovery and Development: The Role of Modeling, Simulation, and Open Data. Issue 4 (11th March 2020) Authors: Conrado, Daniela J.; Duvvuri, Sridhar; Geerts, Hugo; Burton, Jackson; Biesdorf, Carla; Ahamadi, Malidi; Macha, Sreeraj; Hather, Gregory; Francisco Morales, Juan; Podichetty, Jagdeep; Nicholas, Timothy; Stephenson, Diane; Trame, Mirjam; Romero, Klaus; Corrigan, Brian Journal: Clinical pharmacology & therapeutics Issue: Volume 107:Issue 4(2020) Page Start: 796 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. Development of a Disease Progression Model for Leucine‐Rich Repeat Kinase 2 in Parkinson's Disease to Inform Clinical Trial Designs. Issue 3 (5th December 2019) Authors: Ahamadi, Malidi; Conrado, Daniela J; Macha, Sreeraj; Sinha, Vikram; Stone, Julie; Burton, Jackson; Nicholas, Timothy; Gallagher, Jill; Dexter, David; Bani, Massimo; Boroojerdi, Babak; Smit, Hans; Weidemann, Jonas; Chen, Chao; Yang, Minhua; Maciuca, Romeo; Lawson, Rachael; Burn, David; Marek, Kenn... Journal: Clinical pharmacology & therapeutics Issue: Volume 107:Issue 3(2020) Page Start: 553 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. Dopamine Transporter Neuroimaging as an Enrichment Biomarker in Early Parkinson's Disease Clinical Trials: A Disease Progression Modeling Analysis. Issue 1 (27th July 2017) Authors: Conrado, Daniela J.; Nicholas, Timothy; Tsai, Kuenhi; Macha, Sreeraj; Sinha, Vikram; Stone, Julie; Corrigan, Brian; Bani, Massimo; Muglia, Pierandrea; Watson, Ian A.; Kern, Volker D.; Sheveleva, Elena; Marek, Kenneth; Stephenson, Diane T.; Romero, Klaus Journal: Clinical and translational science Issue: Volume 11:Issue 1(2018) Page Start: 63 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. Evaluation of QT Liability for PF‐05251749 in the Presence of Potential Circadian Rhythm Modification. (25th December 2019) Authors: Huh, Yeamin; Chen, Danny; Riley, Steve; Chang, Cheng; Nicholas, Timothy Journal: CPT: pharmacometrics & systems pharmacology Issue: Volume 9:Number 1(2020) Page Start: 60 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. Exposure‐Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Issue 1 (27th April 2022) Authors: Mukherjee, Arnab; Tsuchiwata, Shinichi; Nicholas, Timothy; Cook, Jack A.; Modesto, Irene; Su, Chinyu; D'Haens, Geert R.; Sandborn, William J. Journal: Clinical pharmacology & therapeutics Issue: Volume 112:Issue 1(2022) Page Start: 90 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. Hippocampal Neuroimaging‐Informed Clinical Trial Enrichment Tool for Amnestic Mild Cognitive Impairment Using Open Data. Issue 4 (7th March 2020) Authors: Conrado, Daniela J.; Burton, Jackson; Hill, Derek; Willis, Brian; Sinha, Vikram; Stone, Julie; Coello, Neva; Wang, Wenping; Chen, Danny; Nicholas, Timothy; Gold, Michael; Hartley, Emily; Kern, Volker D.; Romero, Klaus Journal: Clinical pharmacology & therapeutics Issue: Volume 107:Issue 4(2020) Page Start: 903 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease. Issue 3 (18th March 2019) Authors: Romero, Klaus; Conrado, Daniela; Burton, Jackson; Nicholas, Timothy; Sinha, Vikram; Macha, Sreeraj; Ahamadi, Malidi; Cedarbaum, Jesse; Seibyl, John; Marek, Kenneth; Basseches, Peter; Hill, Derek; Somer, Ed; Gallagher, Jill; Dexter, David T.; Roach, Arthur; Stephenson, Diane Journal: Clinical and translational science Issue: Volume 12:Issue 3(2019) Page Start: 240 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. P1–351: A novel BACE inhibitor (PF‐05297909): A two‐part adaptive design to evaluate safety, pharmacokinetics and pharmacodynamics for modifying beta‐amyloid in a first‐in‐human study. (1st July 2013) Authors: Bell, Joanne; O'Neill, Brian; Brodney, Michael; Hajos‐Korcsok, Eva; Lu, Yasong; Riddell, David; Ito, Kaori; Ueckert, Sebastian; Nicholas, Timothy Journal: Alzheimer's & dementia Issue: Volume 9:Supplement 4S(2013)Part 7 Page Start: P287 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗