Works matching IS 00099236 AND DT 2019 AND VI 106 AND IP 1

Results: 44

CORRIGENDUM: Thorough QT/QTc in a Dish: An In Vitro Human Model That Accurately Predicts Clinical Concentration‐QTc Relationships.
Published in:
2019
Publication type:
Correction Notice
In This Issue.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 9, doi. 10.1002/cpt.1488
Publication type:
Article
Highlights.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 19, doi. 10.1002/cpt.1487
Publication type:
Article
What Does It Take to Transform Real‐World Data Into Real‐World Evidence?
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 10, doi. 10.1002/cpt.1486
By:
- Ramamoorthy, Anuradha;
- Huang, Shiew‐Mei
Publication type:
Article
ASCPT News.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 21, doi. 10.1002/cpt.1485
Publication type:
Article
Opportunities and Challenges of Using Big Data to Detect Drug‐Drug Interaction Risk.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 72, doi. 10.1002/cpt.1481
By:
- Quinney, Sara K.
Publication type:
Article
A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 103, doi. 10.1002/cpt.1480
By:
- Gatto, Nicolle M.;
- Reynolds, Robert F.;
- Campbell, Ulka B.
Publication type:
Article
Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 174, doi. 10.1002/cpt.1479
By:
- Hu, Meng;
- Babiskin, Andrew;
- Wittayanukorn, Saranrat;
- Schick, Andreas;
- Rosenberg, Matthew;
- Gong, Xiajing;
- Kim, Myong‐Jin;
- Zhang, Lei;
- Lionberger, Robert;
- Zhao, Liang
Publication type:
Article
Effect of Body Weight on Risk‐Benefit and Dosing Regimen Recommendation of Secukinumab for the Treatment of Moderate to Severe Plaque Psoriasis.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 78, doi. 10.1002/cpt.1478
By:
- Lee, Jee Eun;
- Wang, Jie;
- Florian, Jeffry;
- Wang, Yow‐Ming;
- Kettl, David;
- Marcus, Kendall;
- Woitach, Amy
Publication type:
Article
Real‐World Data: An Unrealized Opportunity in Global Health?
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 57, doi. 10.1002/cpt.1476
By:
- Barrett, Jeffrey S.;
- Heaton, Penny M.
Publication type:
Article
Model‐Informed Drug Development: A Regulatory Perspective on Progress.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 91, doi. 10.1002/cpt.1475
By:
- Zhu, Hao;
- Huang, Shiew Mei;
- Madabushi, Rajanikanth;
- Strauss, David G.;
- Wang, Yaning;
- Zineh, Issam
Publication type:
Article
Small But Mighty: The Use of Real‐World Evidence to Inform Precision Medicine.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 87, doi. 10.1002/cpt.1466
By:
- Miksad, Rebecca A.;
- Samant, Meghna K.;
- Sarkar, Somnath;
- Abernethy, Amy P.
Publication type:
Article
The Missing Reality of Real Life in Real‐World Evidence.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 136, doi. 10.1002/cpt.1465
By:
- Okun, Sally
Publication type:
Article
Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 123, doi. 10.1002/cpt.1461
By:
- Raju, G. K.;
- Gurumurthi, Karthik;
- Domike, Reuben;
- Theoret, Marc R.;
- Pazdur, Richard;
- Woodcock, Janet
Publication type:
Article
Information Patients Can Provide Will Strengthen the Real‐World Evidence That Matters to Them.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 49, doi. 10.1002/cpt.1460
By:
- Nowell, W. Benjamin
Publication type:
Article
Harnessing the Power of Collaboration and Training Within Clinical Data Science to Generate Real‐World Evidence in the Era of Precision Oncology.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 60, doi. 10.1002/cpt.1459
By:
- Rivera, Donna R.;
- Lee, Jerry S. H.;
- Hsu, Elizabeth;
- Khoury, Muin J.;
- Meng, Frank;
- Olivero, Ofelia;
- Penberthy, Lynne;
- Tourassi, Georgia D.
Publication type:
Article
Liver Microphysiological Systems for Predicting and Evaluating Drug Effects.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 139, doi. 10.1002/cpt.1458
By:
- Ribeiro, Alexandre J. S.;
- Yang, Xinning;
- Patel, Vikram;
- Madabushi, Rajnikanth;
- Strauss, David G.
Publication type:
Article
The US Food and Drug Administration's Model‐Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 74, doi. 10.1002/cpt.1457
By:
- Madabushi, Rajanikanth;
- Benjamin, Jessica M.;
- Grewal, Renmeet;
- Pacanowski, Michael A.;
- Strauss, David G.;
- Wang, Yaning;
- Zhu, Hao;
- Zineh, Issam
Publication type:
Article
Decentralized Trials in the Age of Real‐World Evidence and Inclusivity in Clinical Investigations.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 25, doi. 10.1002/cpt.1441
By:
- Khozin, Sean;
- Coravos, Andrea
Publication type:
Article
Can Digital Health Enable Higher Quality Real‐World Evidence‐Based Decisions?
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 45, doi. 10.1002/cpt.1440
By:
- Dickmann, Leslie J.;
- Kothare, Prajakti A.
Publication type:
Article
Evaluation of Maternal Drug Exposure Following the Administration of Antenatal Corticosteroids During Late Pregnancy Using Physiologically‐Based Pharmacokinetic Modeling.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 164, doi. 10.1002/cpt.1438
By:
- Ke, Alice Ban;
- Milad, Mark A.
Publication type:
Article
Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 36, doi. 10.1002/cpt.1426
By:
- Cave, Alison;
- Kurz, Xavier;
- Arlett, Peter
Publication type:
Article
From Discovery to Practice and Survivorship: Building a National Real‐World Data Learning Healthcare Framework for Military and Veteran Cancer Patients.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 52, doi. 10.1002/cpt.1425
By:
- Lee, Jerry S. H.;
- Darcy, Kathleen M.;
- Hu, Hai;
- Casablanca, Yovanni;
- Conrads, Thomas P.;
- Dalgard, Clifton L.;
- Freymann, John B.;
- Hanlon, Sean E.;
- Huang, Grant D.;
- Kvecher, Leonid;
- Maxwell, George L.;
- Meng, Frank;
- Moncur, Joel T.;
- Turner, Clesson;
- Wells, Justin M.;
- Wilkerson, Matthew D.;
- Zhu, Kangmin;
- Ramoni, Rachel B.;
- Shriver, Craig D.
Publication type:
Article
Proceedings of a Workshop: US Food and Drug Administration‐International Society of Pharmacometrics Model‐Informed Drug Development in Oncology.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 81, doi. 10.1002/cpt.1421
By:
- Bruno, Rene;
- Jin, Jin Y.;
- Maxfield, Kimberly;
- Milligan, Lauren;
- Liu, Chao;
- Wang, Yaning;
- McKee, Amy E.;
- Zineh, Issam
Publication type:
Article
Assessing the Structural and Pharmacological Similarity of Newly Identified Drugs of Abuse to Controlled Substances Using Public Health Assessment via Structural Evaluation.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 116, doi. 10.1002/cpt.1418
By:
- Ellis, Christopher R.;
- Racz, Rebecca;
- Kruhlak, Naomi L.;
- Kim, Marlene T.;
- Hawkins, Edward G.;
- Strauss, David G.;
- Stavitskaya, Lidiya
Publication type:
Article
Real‐World Data for Pediatric Pharmacometrics: Can We Upcycle Clinical Data for Research Use?
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 84, doi. 10.1002/cpt.1416
By:
- Van Driest, Sara L.;
- Choi, Leena
Publication type:
Article
Real‐World Data, Advanced Analytics, and the Evolution of Postmarket Drug Safety Surveillance.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 28, doi. 10.1002/cpt.1415
By:
- Dal Pan, Gerald J.
Publication type:
Article
Barriers and Opportunities for Use of Patient Registries in Medicines Regulation.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 39, doi. 10.1002/cpt.1414
By:
- Olmo, Carla Alonso;
- McGettigan, Patricia;
- Kurz, Xavier
Publication type:
Article
Real‐World Data and Clinical Pharmacology: A Regulatory Science Perspective.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 67, doi. 10.1002/cpt.1413
By:
- Liu, Qi;
- Ramamoorthy, Anuradha;
- Huang, Shiew‐Mei
Publication type:
Article
Clinical Pharmacogenetics Implementation Consortium Guideline for Cytochrome P450 (CYP)2D6 Genotype and Atomoxetine Therapy.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 94, doi. 10.1002/cpt.1409
By:
- Brown, Jacob T.;
- Bishop, Jeffrey R.;
- Sangkuhl, Katrin;
- Nurmi, Erika L.;
- Mueller, Daniel J.;
- Dinh, Jean C.;
- Gaedigk, Andrea;
- Klein, Teri E.;
- Caudle, Kelly E.;
- McCracken, James T.;
- Leon, Jose;
- Leeder, J. Steven
Publication type:
Article
Real‐World Evidence of Treatment Effects: The Useful and the Misleading.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 43, doi. 10.1002/cpt.1405
By:
- Schneeweiss, Sebastian
Publication type:
Article
The US Food and Drug Administration's Real‐World Evidence Framework: A Commitment for Engagement and Transparency on Real‐World Evidence.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 33, doi. 10.1002/cpt.1389
By:
- ElZarrad, M. Khair;
- Corrigan‐Curay, Jacqueline
Publication type:
Article
A Drug Is not an Outcome: Extending Translation Through Implementation Using Real‐World Data.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 47, doi. 10.1002/cpt.1382
By:
- Shaywitz, David A.
Publication type:
Article
Advances in the Use of Real‐World Evidence for Medical Devices: An Update From the National Evaluation System for Health Technology.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 30, doi. 10.1002/cpt.1380
By:
- Fleurence, Rachael L.;
- Shuren, Jeffrey
Publication type:
Article
Comparison of Different Strategies to Measure Medication Adherence via Claims Data in Patients With Chronic Heart Failure.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 211, doi. 10.1002/cpt.1378
By:
- Ihle, Peter;
- Krueger, Katrin;
- Schubert, Ingrid;
- Griese‐Mammen, Nina;
- Parrau, Natalie;
- Laufs, Ulrich;
- Schulz, Martin
Publication type:
Article
A Case‐Crossover–Based Screening Approach to Identifying Clinically Relevant Drug–Drug Interactions in Electronic Healthcare Data.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 238, doi. 10.1002/cpt.1376
By:
- Bykov, Katsiaryna;
- Schneeweiss, Sebastian;
- Glynn, Robert J.;
- Mittleman, Murray A.;
- Gagne, Joshua J.
Publication type:
Article
Drug‐Induced Liver Injury due to Flucloxacillin: Relevance of Multiple Human Leukocyte Antigen Alleles.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 245, doi. 10.1002/cpt.1375
By:
- Nicoletti, Paola;
- Aithal, Guruprasad P.;
- Chamberlain, Thomas C.;
- Coulthard, Sally;
- Alshabeeb, Mohammad;
- Grove, Jane I.;
- Andrade, Raul J.;
- Bjornsson, Einar;
- Dillon, John F.;
- Hallberg, Par;
- Lucena, M. Isabel;
- Maitland‐van der Zee, Anke H.;
- Martin, Jennifer H.;
- Molokhia, Mariam;
- Pirmohamed, Munir;
- Wadelius, Mia;
- Shen, Yufeng;
- Nelson, Matthew R.;
- Daly, Ann K.
Publication type:
Article
Interindividual and Regional Variability in Drug Transporter Abundance at the Human Blood–Brain Barrier Measured by Quantitative Targeted Proteomics.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 228, doi. 10.1002/cpt.1373
By:
- Billington, Sarah;
- Salphati, Laurent;
- Hop, Cornelis E. C. A.;
- Chu, Xiaoyan;
- Evers, Raymond;
- Burdette, Doug;
- Rowbottom, Christopher;
- Lai, Yurong;
- Xiao, Guangqing;
- Humphreys, W. Griffith;
- Nguyen, Tot Bui;
- Prasad, Bhagwat;
- Unadkat, Jashvant D.
Publication type:
Article
Demonstrating Heterogeneity of Treatment Effects Among Patients: An Overlooked but Important Step Toward Precision Medicine.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 204, doi. 10.1002/cpt.1372
By:
- Gewandter, Jennifer S.;
- McDermott, Michael P.;
- He, Hua;
- Gao, Shan;
- Cai, Xueya;
- Farrar, John T.;
- Katz, Nathaniel P.;
- Markman, John D.;
- Senn, Stephen;
- Turk, Dennis C.;
- Dworkin, Robert H.
Publication type:
Article
Effectiveness and Safety of Clopidogrel Co‐administered With Statins and Proton Pump Inhibitors: A Korean National Health Insurance Database Study.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 182, doi. 10.1002/cpt.1361
By:
- Kim, Mi‐Sook;
- Song, Hong Ji;
- Lee, Joongyub;
- Yang, Bo Ram;
- Choi, Nam‐Kyong;
- Park, Byung‐Joo
Publication type:
Article
Anastrozole Aromatase Inhibitor Plasma Drug Concentration Genome‐Wide Association Study: Functional Epistatic Interaction Between SLC38A7 and ALPPL2.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 219, doi. 10.1002/cpt.1359
By:
- Dudenkov, Tanda M.;
- Liu, Duan;
- Cairns, Junmei;
- Devarajan, Sandhya;
- Zhuang, Yongxian;
- Ingle, James N.;
- Buzdar, Aman U.;
- Robson, Mark E.;
- Kubo, Michiaki;
- Batzler, Anthony;
- Barman, Poulami;
- Jenkins, Gregory D.;
- Carlson, Erin E.;
- Goetz, Matthew P.;
- Northfelt, Donald W.;
- Moreno‐Aspitia, Alvaro;
- Desta, Zeruesenay;
- Reid, Joel M.;
- Kalari, Krishna R.;
- Wang, Liewei
Publication type:
Article
Switchability of Gabapentin Formulations: A Randomized Trial to Assess Bioequivalence Between Neurontin and Gabasandoz on the Individual Subject Level.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 195, doi. 10.1002/cpt.1353
By:
- Van Lancker, Griet;
- Van Bortel, Luc;
- Delafontaine, Brant;
- Boussery, Koen;
- Swart, Eleonora;
- Chahbouni, Abdel;
- Van Bocxlaer, Jan;
- Colin, Pieter
Publication type:
Article
Tumor Drug Penetration Measurements Could Be the Neglected Piece of the Personalized Cancer Treatment Puzzle.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 148, doi. 10.1002/cpt.1211
By:
- Bartelink, Imke H.;
- Jones, Ella F.;
- Shahidi‐Latham, Sheerin K.;
- Lee, Pei Rong Evelyn;
- Zheng, Yanan;
- Vicini, Paolo;
- 't Veer, Laura;
- Wolf, Denise;
- Iagaru, Andrei;
- Kroetz, Deanna L.;
- Prideaux, Brendan;
- Cilliers, Cornelius;
- Thurber, Greg M.;
- Wimana, Zena;
- Gebhart, Geraldine
Publication type:
Article
Issue Information.
Published in:
Clinical Pharmacology & Therapeutics, 2019, v. 106, n. 1, p. 1, doi. 10.1002/cpt.1156
Publication type:
Article