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A Drug‐Drug Interaction Study Evaluating the Effect of Givosiran, a Small Interfering Ribonucleic Acid, on Cytochrome P450 Activity in the Liver.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1250, doi. 10.1002/cpt.2419
By:
- Vassiliou, Daphne;
- Sardh, Eliane;
- Harper, Pauline;
- Simon, Amy R.;
- Clausen, Valerie A.;
- Najafian, Nader;
- Robbie, Gabriel J.;
- Agarwal, Sagar
Publication type:
Article
Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1311, doi. 10.1002/cpt.2411
By:
- Correia Pinheiro, Luis;
- Giezen, Thijs J.;
- Wolff‐Holz, Elena;
- Weise, Martina;
- Laslop, Andrea;
- Hidalgo‐Simon, Ana
Publication type:
Article
Model‐Informed Drug Development: Connecting the Dots With a Totality of Evidence Mindset to Advance Therapeutics.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1147, doi. 10.1002/cpt.2422
By:
- Venkatakrishnan, Karthik;
- van der Graaf, Piet H.
Publication type:
Article
Population Pharmacokinetics and Pharmacodynamics of the Neutralizing Antibodies Bamlanivimab and Etesevimab in Patients With Mild to Moderate COVID‐19 Infection.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1302, doi. 10.1002/cpt.2420
By:
- Chigutsa, Emmanuel;
- O'Brien, Lisa;
- Ferguson‐Sells, Lisa;
- Long, Amanda;
- Chien, Jenny
Publication type:
Article
Exposure–Response Analyses for Therapeutic Dose Selection of Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1282, doi. 10.1002/cpt.2409
By:
- Ferron‐Brady, Geraldine;
- Rathi, Chetan;
- Collins, Jon;
- Struemper, Herbert;
- Opalinska, Joanna;
- Visser, Sandra;
- Jewell, Roxanne C.
Publication type:
Article
In This Issue.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1145, doi. 10.1002/cpt.2421
Publication type:
Article
ASCPT News.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1157, doi. 10.1002/cpt.2417
Publication type:
Article
Highlights.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1155, doi. 10.1002/cpt.2418
Publication type:
Article
Impact of SARS‐CoV‐2 Infection (COVID‐19) on Cytochromes P450 Activity Assessed by the Geneva Cocktail.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1358, doi. 10.1002/cpt.2412
By:
- Lenoir, Camille;
- Terrier, Jean;
- Gloor, Yvonne;
- Curtin, François;
- Rollason, Victoria;
- Desmeules, Jules Alexandre;
- Daali, Youssef;
- Reny, Jean‐Luc;
- Samer, Caroline Flora
Publication type:
Article
Pharmacogenetic Predictors of Cannabidiol Response and Tolerability in Treatment‐Resistant Epilepsy.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1368, doi. 10.1002/cpt.2408
By:
- Davis, Brittney H.;
- Beasley, T. Mark;
- Amaral, Michelle;
- Szaflarski, Jerzy P.;
- Gaston, Tyler;
- Perry Grayson, Leslie;
- Standaert, David G;
- Bebin, E. Martina;
- Limdi, Nita A.
Publication type:
Article
A Model‐Based Workflow to Benchmark the Clinical Cholestasis Risk of Drugs.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1293, doi. 10.1002/cpt.2406
By:
- Baier, Vanessa;
- Clayton, Olivia;
- Nudischer, Ramona;
- Cordes, Henrik;
- Schneider, Annika R. P.;
- Thiel, Christoph;
- Wittenberger, Timo;
- Moritz, Wolfgang;
- Blank, Lars M.;
- Neumann, Ulf P.;
- Trautwein, Christian;
- Kelm, Jens;
- Schrooders, Yannick;
- Caiment, Florian;
- Gmuender, Hans;
- Roth, Adrian;
- Castell, José V.;
- Kleinjans, Jos;
- Kuepfer, Lars
Publication type:
Article
Quantitative Proteomic Map of Enzymes and Transporters in the Human Kidney: Stepping Closer to Mechanistic Kidney Models to Define Local Kinetics.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1389, doi. 10.1002/cpt.2396
By:
- Al‐Majdoub, Zubida M.;
- Scotcher, Daniel;
- Achour, Brahim;
- Barber, Jill;
- Galetin, Aleksandra;
- Rostami‐Hodjegan, Amin
Publication type:
Article
Corrigendum: Developing and Validating a Clinical Warfarin Dose‐Initiation Model for Black‐African Patients in South Africa and Uganda.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1402, doi. 10.1002/cpt.2395
Publication type:
Article
Investigation of Factors Associated With Immunogenicity Labeling Updates and Characteristics of Biologics License Applications.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1381, doi. 10.1002/cpt.2393
By:
- Jiang, Ai‐Lei;
- Breder, Christopher D.;
- Chang, Lin‐Chau
Publication type:
Article
Hypothalamic‐Pituitary‐Adrenal Activity in Adverse Events Reporting After Placebo Administration.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1349, doi. 10.1002/cpt.2388
By:
- Benedetti, Fabrizio;
- Amanzio, Martina;
- Giovannelli, Fabio;
- Craigs‐Brackhahn, Karen;
- Shaibani, Aziz
Publication type:
Article
Safety, Tolerability, and Pharmacokinetics of High‐Volume Subcutaneous Crenezumab, With and Without Recombinant Human Hyaluronidase in Healthy Volunteers.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1337, doi. 10.1002/cpt.2385
By:
- Dolton, Michael J.;
- Chesterman, Aaron;
- Moein, Anita;
- Sink, Kaycee M.;
- Waitz, Ariel;
- Blondeau, Kathleen;
- Kerchner, Geoffrey A.;
- Hu, Nan;
- Brooks, Logan;
- Wetzel‐Smith, Monica K.;
- Roden, Amanda;
- Deshmukh, Ajay;
- Peng, Kun;
- Carrasco‐Triguero, Montserrat;
- Smith, Jill;
- Ostrowitzki, Susanne;
- Quartino, Angelica
Publication type:
Article
Metformin Stimulates Intestinal Glycolysis and Lactate Release: A single‐Dose Study of Metformin in Patients With Intrahepatic Portosystemic Stent.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1329, doi. 10.1002/cpt.2382
By:
- Rittig, Nikolaj;
- Aagaard, Niels K.;
- Sundelin, Elias;
- Villadsen, Gerda E.;
- Sandahl, Thomas D.;
- Holst, Jens J.;
- Hartmann, Bolette;
- Brøsen, Kim;
- Grønbæk, Henning;
- Jessen, Niels
Publication type:
Article
Current and Next Steps Toward Prediction of Human Dose for Gene Therapy Using Translational Dose‐Response Studies.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1176, doi. 10.1002/cpt.2374
By:
- Aksenov, Sergey;
- Roberts, John C.;
- Mugundu, Ganesh;
- Mueller, Karen Thudium;
- Bhattacharya, Indranil;
- Tortorici, Michael A.
Publication type:
Article
Optimized Alectinib Dose Regimen for Treatment of Patients With ALK‐Positive Non‐Small Cell Lung Cancer Based on Robust Pharmacometric Analyses and Clinical Evidence.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1162, doi. 10.1002/cpt.2373
By:
- Frey, Nicolas;
- Bordogna, Walter;
- Balas, Bogdana;
- Ruf, Thorsten;
- Archer, Venice;
- Guerini, Elena
Publication type:
Article
Response to "Optimized Alectinib Dose Regimen for Treatment of Patients With ALK‐Positive NSCLC Based on Robust Pharmacometric Analyses and Clinical Evidence".
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1164, doi. 10.1002/cpt.2372
By:
- Groenland, Stefanie L.;
- Geel, Dieuwertje R.;
- Beijnen, Jos H.;
- Smit, Egbert F.;
- Huitema, Alwin D. R.;
- Steeghs, Neeltje
Publication type:
Article
The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1318, doi. 10.1002/cpt.2366
By:
- Kamal, Mohamed A.;
- Kovalenko, Pavel;
- Kosloski, Matthew P.;
- Srinivasan, Kamal;
- Zhang, Yi;
- Rajadhyaksha, Manoj;
- Lai, Ching‐Ha;
- Kanamaluru, Vanaja;
- Xu, Christine;
- Sun, Xian;
- Simpson, Eric L.;
- Paller, Amy S.;
- Siegfried, Elaine C.;
- Shumel, Brad;
- Bansal, Ashish;
- Al‐Huniti, Nidal;
- Davis, John D.
Publication type:
Article
Erratum: A Model Averaging/Selection Approach Improves the Predictive Performance of Model‐Informed Precision Dosing: Vancomycin as a Case Study.
Published in:
2021
Publication type:
Correction Notice
A Model‐Based Approach to Assess Unstable Creatinine Clearance in Critically Ill Patients.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1240, doi. 10.1002/cpt.2341
By:
- Ullah, Sami;
- Zoller, Michael;
- Jaehde, Ulrich;
- Huseyn‐Zada, Mikayil;
- Weig, Thomas;
- Fuhr, Uwe;
- Arshad, Usman;
- Zander, Johannes;
- Taubert, Max
Publication type:
Article
Quantitative Clinical Pharmacology Supports the Bridging From i.v. Dosing and Approval of s.c. Rituximab in B‐Cell Hematological Malignancies.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1261, doi. 10.1002/cpt.2308
By:
- Jamois, Candice;
- Gibiansky, Ekaterina;
- Gibiansky, Leonid;
- Chavanne, Clarisse;
- Morcos, Peter N.;
- McIntyre, Christine;
- Barrett, Martin;
- Lundberg, Linda;
- Zharkov, Artem;
- Boehnke, Axel;
- Frey, Nicolas
Publication type:
Article
Model‐Informed Therapeutic Dose Optimization Strategies for Antibody–Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration–Approved Antibody–Drug Conjugates?
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1216, doi. 10.1002/cpt.2278
By:
- Liao, Michael Z.;
- Lu, Dan;
- Kågedal, Matts;
- Miles, Dale;
- Samineni, Divya;
- Liu, Stephanie N.;
- Li, Chunze
Publication type:
Article
Lorlatinib Exposure‐Response Analyses for Safety and Efficacy in a Phase I/II Trial to Support Benefit–Risk Assessment in Non‐Small Cell Lung Cancer.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1273, doi. 10.1002/cpt.2228
By:
- Chen, Joseph;
- Ruiz‐Garcia, Ana;
- James, Leonard P.;
- Peltz, Gerson;
- Thurm, Holger;
- Clancy, Jill;
- Hibma, Jennifer
Publication type:
Article
Physiologically‐Based Pharmacokinetic Modeling to Support the Clinical Management of Drug–Drug Interactions With Bictegravir.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1231, doi. 10.1002/cpt.2221
By:
- Stader, Felix;
- Battegay, Manuel;
- Marzolini, Catia
Publication type:
Article
Moving From Point‐Based Analysis to Systems‐Based Modeling: Integration of Knowledge to Address Antimicrobial Resistance Against MDR Bacteria.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1196, doi. 10.1002/cpt.2219
By:
- Garcia, Estefany;
- Ly, Neang;
- Diep, John K.;
- Rao, Gauri G.
Publication type:
Article
Industrial Perspective on the Benefits Realized From the FDA's Model‐Informed Drug Development Paired Meeting Pilot Program.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1172, doi. 10.1002/cpt.2265
By:
- Galluppi, Gerald R.;
- Brar, Satjit;
- Caro, Luzelena;
- Chen, Yuan;
- Frey, Nicolas;
- Grimm, Hans Peter;
- Rudd, Deanne Jackson;
- Li, Chi‐Chung;
- Magee, Mindy;
- Mukherjee, Arnab;
- Nagao, Lee;
- Purohit, Vivek S.;
- Roy, Amit;
- Salem, Ahmed Hamed;
- Sinha, Vikram;
- Suleiman, Ahmed A.;
- Taskar, Kunal S.;
- Upreti, Vijay V.;
- Weber, Benjamin;
- Cook, Jack
Publication type:
Article
Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model‐Based Bioequivalence.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1190, doi. 10.1002/cpt.2120
By:
- Lee, Jieon;
- Gong, Yuqing;
- Bhoopathy, Sid;
- DiLiberti, Charles E.;
- Hooker, Andrew C.;
- Rostami‐Hodjegan, Amin;
- Schmidt, Stephan;
- Suarez‐Sharp, Sandra;
- Lukacova, Viera;
- Fang, Lanyan;
- Zhao, Liang
Publication type:
Article
An Integrated Approach for Assessing the Impact of Renal Impairment on Pharmacokinetics of Drugs in Development: Pivotal Role of PBPK Modelling.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1168, doi. 10.1002/cpt.2243
By:
- Rowland Yeo, Karen;
- Gil Berglund, Eva
Publication type:
Article
Clinical Design and Analysis Strategies for the Development of Gene Therapies: Considerations for Quantitative Drug Development in the Age of Genetic Medicine.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1207, doi. 10.1002/cpt.2224
By:
- McIntosh, Avery;
- Sverdlov, Oleksandr;
- Yu, Li;
- Kaufmann, Petra
Publication type:
Article
Model Informed Drug Development: Collaboration Through A Common Framework.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1165, doi. 10.1002/cpt.2066
By:
- Anziano, Richard J.;
- Milligan, Peter A.
Publication type:
Article
Issue Information.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1137, doi. 10.1002/cpt.1905
Publication type:
Article
The Evidence REVEAL Study: Exploring the Use of Real‐World Evidence and Complex Clinical Trial Design by the European Pharmaceutical Industry.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1180, doi. 10.1002/cpt.2103
By:
- Varnai, Peter;
- Davé, Anoushka;
- Farla, Kristine;
- Nooijen, Anke;
- Petrosova, Liana
Publication type:
Article

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