Works matching IS 00099236 AND DT 2021 AND VI 109 AND IP 2

Results: 34

Highlights.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 283, doi. 10.1002/cpt.2139
Publication type:
Article
ASCPT News.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 285, doi. 10.1002/cpt.2147
Publication type:
Article
In This Issue.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 279, doi. 10.1002/cpt.2138
Publication type:
Article
Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates).
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 319, doi. 10.1002/cpt.2137
By:
- Strauss, David G.;
- Wu, Wendy W.;
- Li, Zhihua;
- Koerner, John;
- Garnett, Christine
Publication type:
Article
Toward Replacement of Thorough QT Studies.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 281, doi. 10.1002/cpt.2136
By:
- Graaf, Piet H.
Publication type:
Article
Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 310, doi. 10.1002/cpt.2029
By:
- Vargas, Hugo M.;
- Rolf, Michael G.;
- Wisialowski, Todd A.;
- Achanzar, William;
- Bahinski, Anthony;
- Bass, Alan;
- Benson, Charles T;
- Chaudhary, Khuram W.;
- Couvreur, Nicolas;
- Dota, Corina;
- Engwall, Michael J;
- Michael Foley, C.;
- Gallacher, David;
- Greiter‐Wilke, Andrea;
- Guillon, Jean‐Michel;
- Guth, Brian;
- Himmel, Herbert M.;
- Hegele‐Hartung, Christa;
- Ito, Maki;
- Jenkinson, Stephen
Publication type:
Article
Are Seniors Dependent on Benzodiazepines? A National Clinical Survey of Substance Use Disorder.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 528, doi. 10.1002/cpt.2025
By:
- Victorri‐Vigneau, Caroline;
- Laforgue, Edouard‐Jules;
- Grall‐Bronnec, Marie;
- Guillou‐Landreat, Morgane;
- Rousselet, Morgane;
- Guerlais, Marylène;
- Feuillet, Fanny;
- Jolliet, Pascale
Publication type:
Article
Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 536, doi. 10.1002/cpt.2024
By:
- Katz, Eva G.;
- Hough, David;
- Doherty, Teodora;
- Lane, Rosanne;
- Singh, Jaskaran;
- Levitan, Bennett
Publication type:
Article
Model‐Based Meta‐Analysis Compares DAS28 Rheumatoid Arthritis Treatment Effects and Suggests an Expedited Trial Design for Early Clinical Development.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 517, doi. 10.1002/cpt.2023
By:
- Leil, Tarek A.;
- Lu, Yasong;
- Bouillon‐Pichault, Marion;
- Wong, Robert;
- Nowak, Miroslawa
Publication type:
Article
Identification of Appropriate Endogenous Biomarker for Risk Assessment of Multidrug and Toxin Extrusion Protein‐Mediated Drug‐Drug Interactions in Healthy Volunteers.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 507, doi. 10.1002/cpt.2022
By:
- Miyake, Takeshi;
- Kimoto, Emi;
- Luo, Lina;
- Mathialagan, Sumathy;
- Horlbogen, Lauren M.;
- Ramanathan, Ragu;
- Wood, Linda S.;
- Johnson, Jillian G.;
- Le, Vu H.;
- Vourvahis, Manoli;
- Rodrigues, A. David;
- Muto, Chieko;
- Furihata, Kenichi;
- Sugiyama, Yuichi;
- Kusuhara, Hiroyuki
Publication type:
Article
Physiologically Based Pharmacokinetic Modeling of Central Nervous System Pharmacokinetics of CDK4/6 Inhibitors to Guide Selection of Drug and Dosing Regimen for Brain Cancer Treatment.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 494, doi. 10.1002/cpt.2021
By:
- Li, Jing;
- Jiang, Jun;
- Wu, Jianmei;
- Bao, Xun;
- Sanai, Nader
Publication type:
Article
Circulating miRNAs as Biomarkers for CYP2B6 Enzyme Activity.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 485, doi. 10.1002/cpt.2018
By:
- Ipe, Joseph;
- Li, Rudong;
- Metzger, Ingrid F.;
- Bo Li Lu, Jessica;
- Gufford, Brandon T.;
- Desta, Zeruesenay;
- Liu, Yunlong;
- Skaar, Todd C.
Publication type:
Article
Clinical Data Combined With Modeling and Simulation Indicate Unchanged Drug‐Drug Interaction Magnitudes in the Elderly.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 471, doi. 10.1002/cpt.2017
By:
- Stader, Felix;
- Courlet, Perrine;
- Kinvig, Hannah;
- Penny, Melissa A.;
- Decosterd, Laurent A.;
- Battegay, Manuel;
- Siccardi, Marco;
- Marzolini, Catia
Publication type:
Article
Regulatory CDH4 Genetic Variants Associate With Risk to Develop Capecitabine‐Induced Hand‐Foot Syndrome.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 462, doi. 10.1002/cpt.2013
By:
- Ruiz‐Pinto, Sara;
- Pita, Guillermo;
- Martín, Miguel;
- Nuñez‐Torres, Rocío;
- Cuadrado, Ana;
- Shahbazi, Marta N.;
- Caronia, Daniela;
- Kojic, Alexander;
- Moreno, Leticia T.;
- Torre‐Montero, Julio C.;
- Lozano, María;
- López‐Fernández, Luis A.;
- Ribelles, Nuria;
- García‐Saenz, Jose A.;
- Alba, Emilio;
- Milne, Roger L.;
- Losada, Ana;
- Pérez‐Moreno, Mirna;
- Benítez, Javier;
- González‐Neira, Anna
Publication type:
Article
Use of Real‐World Data to Emulate a Clinical Trial and Support Regulatory Decision Making: Assessing the Impact of Temporality, Comparator Choice, and Method of Adjustment.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 452, doi. 10.1002/cpt.2012
By:
- Abrahami, Devin;
- Pradhan, Richeek;
- Yin, Hui;
- Honig, Peter;
- Baumfeld Andre, Elodie;
- Azoulay, Laurent
Publication type:
Article
Efficacy and Safety of Ticagrelor vs. Clopidogrel in East Asian Patients with Acute Myocardial Infarction: A Nationwide Cohort Study.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 443, doi. 10.1002/cpt.2011
By:
- Chang, Chi‐Jen;
- Tung, Ying‐Chang;
- Liu, Jia‐Rou;
- Chang, Shu‐Hao;
- Kuo, Chi‐Tai;
- See, Lai‐Chu
Publication type:
Article
Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C9 and HLA‐B Genotypes and Phenytoin Dosing: 2020 Update.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 302, doi. 10.1002/cpt.2008
By:
- Karnes, Jason H.;
- Rettie, Allan E.;
- Somogyi, Andrew A.;
- Huddart, Rachel;
- Fohner, Alison E.;
- Formea, Christine M.;
- Ta Michael Lee, Ming;
- Llerena, Adrian;
- Whirl‐Carrillo, Michelle;
- Klein, Teri E.;
- Phillips, Elizabeth J.;
- Mintzer, Scott;
- Gaedigk, Andrea;
- Caudle, Kelly E.;
- Callaghan, John T.
Publication type:
Article
Quantitative Systems Toxicology Modeling Predicts that Reduced Biliary Efflux Contributes to Tolvaptan Hepatotoxicity.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 433, doi. 10.1002/cpt.2007
By:
- Beaudoin, James J.;
- Brock, William J.;
- Watkins, Paul B.;
- Brouwer, Kim L. R.
Publication type:
Article
Integrated Mechanistic Model of Minimal Residual Disease Kinetics With Venetoclax Therapy in Chronic Lymphocytic Leukemia.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 424, doi. 10.1002/cpt.2005
By:
- Gopalakrishnan, Sathej;
- Wierda, William;
- Chyla, Brenda;
- Menon, Rajeev;
- Miles, Dale;
- Humerickhouse, Rod;
- Awni, Walid;
- Salem, Ahmed Hamed;
- Mensing, Sven;
- Freise, Kevin J.
Publication type:
Article
A Time‐to‐Event Model Relating Integrated Craving to Risk of Smoking Relapse Across Different Nicotine Replacement Therapy Formulations.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 416, doi. 10.1002/cpt.2000
By:
- Germovsek, Eva;
- Hansson, Anna;
- Karlsson, Mats O.;
- Westin, Åke;
- Soons, Paul A.;
- Vermeulen, An;
- Kjellsson, Maria C.
Publication type:
Article
International Collaboration in Real‐World Evidence Generation for Direct Acting Oral Anti‐Coagulants.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 299, doi. 10.1002/cpt.1999
By:
- Arlett, Peter;
- Kurz, Xavier;
- Soltys, Katherine;
- Blum, Michael D.
Publication type:
Article
Model‐Informed Drug Development of the Masked Anti‑PD‑L1 Antibody CX‐072.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 383, doi. 10.1002/cpt.1985
By:
- Stroh, Mark;
- Green, Michelle;
- Millard, Bjorn L.;
- Apgar, Joshua F.;
- Burke, John M.;
- Garner, Will;
- Lu, Hong;
- Lyman, Susan K.;
- Desnoyers, Luc R.;
- Richardson, Jennifer;
- Hannah, Alison;
- Kavanaugh, W. Michael
Publication type:
Article
Response to "Strictness and Transparency in Approval Process of Medical Products: Japanese Situation".
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 291, doi. 10.1002/cpt.1996
By:
- Sawano, Toyoaki;
- Ozaki, Akihiko;
- Saito, Hiroaki;
- Shimada, Yuki;
- Tanimoto, Tetsuya
Publication type:
Article
Strictness and Transparency in Approval Process of Medical Products: Japanese Situation.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 290, doi. 10.1002/cpt.1994
By:
- Hashida, Mitsuru
Publication type:
Article
Exposure–Response Analyses of Anaplastic Lymphoma Kinase Inhibitors Crizotinib and Alectinib in Non‐Small Cell Lung Cancer Patients.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 394, doi. 10.1002/cpt.1989
By:
- Groenland, Stefanie L.;
- Geel, Dieuwertje R.;
- Janssen, Julie M.;
- Vries, Niels;
- Rosing, Hilde;
- Beijnen, Jos H.;
- Burgers, Jacobus A.;
- Smit, Egbert F.;
- Huitema, Alwin D.R.;
- Steeghs, Neeltje
Publication type:
Article
PMDA's Vision for Horizon Scanning of Emerging Technologies Potentially Relevant to the Development of New Medical Products: The Regulatory Challenge.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 295, doi. 10.1002/cpt.1986
By:
- Shimokawa, Masafumi;
- Sato, Daisaku;
- Wakao, Rika;
- Arai, Hiroyuki
Publication type:
Article
A Microdose Cocktail to Evaluate Drug Interactions in Patients with Renal Impairment.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 403, doi. 10.1002/cpt.1998
By:
- Tatosian, Daniel A.;
- Yee, Ka Lai;
- Zhang, Zufei;
- Mostoller, Kate;
- Paul, Erina;
- Sutradhar, Santosh;
- Larson, Patrick;
- Chhibber, Aparna;
- Wen, Jianzhong;
- Wang, Ya‐Juan;
- Lassman, Michael;
- Latham, Andrew H.;
- Pang, Jianmei;
- Crumley, Tami;
- Gillespie, Anne;
- Marricco, Nadia Cardillo;
- Marenco, Ted;
- Murphy, Matthew;
- Lasseter, Kenneth C.;
- Marbury, Thomas C.
Publication type:
Article
Market Exclusivity Length for Drugs with New Generic or Biosimilar Competition, 2012–2018.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 367, doi. 10.1002/cpt.1983
By:
- Rome, Benjamin N.;
- Lee, ChangWon C.;
- Kesselheim, Aaron S.
Publication type:
Article
Leveraging Clinical Pharmacology to Optimize Drug Development for Nonalcoholic Steatohepatitis and Cholestatic Liver Diseases: Workshop Report.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 292, doi. 10.1002/cpt.1978
By:
- Kim, Insook;
- Seo, Shirley
Publication type:
Article
Single‐Dose Pharmacokinetics and Pharmacodynamics of Transthyretin Targeting N‐acetylgalactosamine–Small Interfering Ribonucleic Acid Conjugate, Vutrisiran, in Healthy Subjects.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 372, doi. 10.1002/cpt.1974
By:
- Habtemariam, Bahru A.;
- Karsten, Verena;
- Attarwala, Husain;
- Goel, Varun;
- Melch, Megan;
- Clausen, Valerie A.;
- Garg, Pushkal;
- Vaishnaw, Akshay K.;
- Sweetser, Marianne T.;
- Robbie, Gabriel J.;
- Vest, John
Publication type:
Article
PharmVar GeneFocus: CYP2C19.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 352, doi. 10.1002/cpt.1973
By:
- Botton, Mariana R.;
- Whirl‐Carrillo, Michelle;
- Del Tredici, Andria L.;
- Sangkuhl, Katrin;
- Cavallari, Larisa H.;
- Agúndez, José A. G.;
- Duconge, Jorge;
- Lee, Ming Ta Michael;
- Woodahl, Erica L.;
- Claudio‐Campos, Karla;
- Daly, Ann K.;
- Klein, Teri E.;
- Pratt, Victoria M.;
- Scott, Stuart A.;
- Gaedigk, Andrea
Publication type:
Article
Historical Controls in Randomized Clinical Trials: Opportunities and Challenges.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 343, doi. 10.1002/cpt.1970
By:
- Hall, Kathryn T.;
- Vase, Lene;
- Tobias, Deirdre K.;
- Dashti, Hesam T.;
- Vollert, Jan;
- Kaptchuk, Ted J.;
- Cook, Nancy R.
Publication type:
Article
Developing Drugs for Tissue‐Agnostic Indications: A Paradigm Shift in Leveraging Cancer Biology for Precision Medicine.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 334, doi. 10.1002/cpt.1946
By:
- Seligson, Nathan D.;
- Knepper, Todd C.;
- Ragg, Susanne;
- Walko, Christine M.
Publication type:
Article
Issue Information.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 109, n. 2, p. 271, doi. 10.1002/cpt.1896
Publication type:
Article