Works matching IS 2160763X AND DT 2021 AND VI 10 AND IP 9

Results: 15

GLPG1205, a GPR84 Modulator: Safety, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 994, doi. 10.1002/cpdd.955

By:

Timmis, Helen;
Van Kaem, Tim;
Desrivot, Julie;
Dupont, Sonia;
Meuleners, Luc;
Beetens, Johan;
Helmer, Eric;
Santermans, Eva;
Huettner, Silke

Publication type:

Article

Effects of Lemborexant on the Pharmacokinetics of Oral Contraceptives: Results From a Phase 1 Drug‐Drug Interaction Study in Healthy Females.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 1089, doi. 10.1002/cpdd.953

By:

Landry, Ishani;
Aluri, Jagadeesh;
Hall, Nancy;
Filippov, Gleb;
Dayal, Satish;
Moline, Margaret;
Reyderman, Larisa

Publication type:

Article

Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Abacavir/Dolutegravir/Lamivudine Combination Tablets in Healthy Japanese Study Participants.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 985, doi. 10.1002/cpdd.996

By:

Singh, Rajendra P.;
Adkison, Kimberly;
Wolstenholme, Allen;
Hopking, Judy;
Wynne, Brian

Publication type:

Article

Apixaban Single‐Dose Pharmacokinetics, Bioavailability, Renal Clearance, and Pharmacodynamics Following Intravenous and Oral Administration.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 974, doi. 10.1002/cpdd.990

By:

Frost, Charles;
Garonzik, Samira;
Shenker, Andrew;
Barrett, Yu Chen;
LaCreta, Frank

Publication type:

Article

Effects of Itraconazole and Rifampin on the Pharmacokinetics of Mobocertinib (TAK‐788), an Oral Epidermal Growth Factor Receptor Inhibitor, in Healthy Volunteers.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 1044, doi. 10.1002/cpdd.967

By:

Zhang, Steven;
Jin, Shu;
Griffin, Celina;
Feng, Zhongling;
Lin, Jianchang;
Venkatakrishnan, Karthik;
Gupta, Neeraj

Publication type:

Article

Effect of GLPG1205, a GPR84 Modulator, on CYP2C9, CYP2C19, and CYP1A2 Enzymes: In Vitro and Phase 1 Studies.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 1007, doi. 10.1002/cpdd.956

By:

Desrivot, Julie;
Van Kaem, Tim;
Allamassey, Lisa;
Helmer, Eric

Publication type:

Article

Single‐Dose Pharmacokinetics and Tolerability of the Oral Epidermal Growth Factor Receptor Inhibitor Mobocertinib (TAK‐788) in Healthy Volunteers: Low‐Fat Meal Effect and Relative Bioavailability of 2 Capsule Products.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 1028, doi. 10.1002/cpdd.951

By:

Zhang, Steven;
Jin, Shu;
Griffin, Celina;
Feng, Zhongling;
Lin, Jianchang;
Baratta, Mike;
Brake, Rachael;
Venkatakrishnan, Karthik;
Gupta, Neeraj

Publication type:

Article

Human Mass Balance and Metabolite Profiling of [<sup>14</sup>C]‐Pamiparib, a Poly (ADP‐Ribose) Polymerase Inhibitor, in Patients With Advanced Cancer.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 1108, doi. 10.1002/cpdd.943

By:

Mu, Song;
Palmer, Daniel;
Fitzgerald, Richard;
Andreu‐Vieyra, Claudia;
Zhang, Heather;
Tang, Zhiyu;
Su, Dan;
Sahasranaman, Srikumar

Publication type:

Article

Migalastat Tissue Distribution: Extrapolation From Mice to Humans Using Pharmacokinetic Modeling and Comparison With Agalsidase Beta Tissue Distribution in Mice.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 1075, doi. 10.1002/cpdd.941

By:

Wu, Yi Shuan;
Khanna, Richie;
Schmith, Virginia;
Lun, Yi;
Shen, Jin‐Song;
Garcia, Anadina;
Dungan, Leo;
Perry, Anthony;
Martin, Lukas;
Tsai, Pai‐Chi;
Hamler, Rick;
Das, Anibh M.;
Schiffmann, Raphael;
Johnson, Franklin K.

Publication type:

Article

A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single‐Dose, Phase 1 Crossover Trial.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 1099, doi. 10.1002/cpdd.940

By:

Boinpally, Ramesh;
McNamee, Brian;
Yao, Li;
Butler, Matthew;
McGeeney, Danielle;
Borbridge, Lisa;
Periclou, Antonia

Publication type:

Article

Evaluation of the Effects of Repeat‐Dose Dabrafenib on the Single‐Dose Pharmacokinetics of Rosuvastatin (OATP1B1/1B3 Substrate) and Midazolam (CYP3A4 Substrate).

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 1054, doi. 10.1002/cpdd.937

By:

Nebot, Noelia;
Won, Christina S.;
Moreno, Victor;
Muñoz‐Couselo, Eva;
Lee, Dung‐Yang;
Gasal, Eduard;
Bouillaud, Emmanuel

Publication type:

Article

Evaluation of Drug‐Drug Interaction Liability for Buprenorphine Extended‐Release Monthly Injection Administered by Subcutaneous Route.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 1064, doi. 10.1002/cpdd.934

By:

Kharidia, Jahnavi;
Howgate, Eleanor M.;
Laffont, Celine M.;
Liu, Yongzhen;
Young, Malcolm A.

Publication type:

Article

A Pharmacokinetic Bioequivalence Study of Fremanezumab Administered Subcutaneously Using an Autoinjector and a Prefilled Syringe.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 1018, doi. 10.1002/cpdd.902

By:

Cherniakov, Irina;
Cohen‐Barak, Orit;
Tiver, Ryan;
Gillespie, Michael;
Kessler, Yoel;
Gutierrez, Maria;
Rasamoelisolo, Michele;
Li, Shawn;
Shen, Honglue;
Hallak, Hussein;
Loupe, Pippa S.;
Smith, Michael;
Rabinovich‐Guilatt, Laura;
Spiegelstein, Ofer

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 959, doi. 10.1002/cpdd.836
Publication type:: Article

Update on ICH E14/S7B Cardiac Safety Regulations: The Expanded Role of Preclinical Assays and the "Double‐Negative" Scenario.

Published in:: Clinical Pharmacology in Drug Development, 2021, v. 10, n. 9, p. 964, doi. 10.1002/cpdd.1003
Publication type:: Article