No Dose Adjustment for Isavuconazole Based on Age or Sex
Desai, Amit V, Han, David, Kowalski, Donna L, Lademacher, Christopher, Pearlman, Helene, Yamazaki, Takao
Published in Antimicrobial agents and chemotherapy (01.06.2019)
Published in Antimicrobial agents and chemotherapy (01.06.2019)
Get full text
Journal Article
Exposure-Response Relationships for Isavuconazole in Patients with Invasive Aspergillosis and Other Filamentous Fungi
Desai, Amit V, Kovanda, Laura L, Hope, William W, Andes, David, Mouton, Johan W, Kowalski, Donna L, Townsend, Robert W, Mujais, Salim, Bonate, Peter L
Published in Antimicrobial agents and chemotherapy (01.12.2017)
Published in Antimicrobial agents and chemotherapy (01.12.2017)
Get full text
Journal Article
Phase I trial to investigate the effect of renal impairment on isavuconazole pharmacokinetics
Townsend, Robert W., Akhtar, Shahzad, Alcorn, Harry, Berg, Jolene K., Kowalski, Donna L., Mujais, Salim, Desai, Amit V.
Published in European journal of clinical pharmacology (01.06.2017)
Published in European journal of clinical pharmacology (01.06.2017)
Get full text
Journal Article
Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies
Kusawake, Tomohiro, Keirns, James J., Kowalski, Donna, den Adel, Martin, Groenendaal-van de Meent, Dorien, Takada, Akitsugu, Ohtsu, Yoshiaki, Katashima, Masataka
Published in Advances in therapy (01.12.2017)
Published in Advances in therapy (01.12.2017)
Get full text
Journal Article
Pharmacokinetic Interactions Between Isavuconazole and the Drug Transporter Substrates Atorvastatin, Digoxin, Metformin, and Methotrexate in Healthy Subjects
Yamazaki, Takao, Desai, Amit, Goldwater, Ronald, Han, David, Lasseter, Kenneth C., Howieson, Corrie, Akhtar, Shahzad, Kowalski, Donna, Lademacher, Christopher, Rammelsberg, Diane, Townsend, Robert
Published in Clinical pharmacology in drug development (01.01.2017)
Published in Clinical pharmacology in drug development (01.01.2017)
Get full text
Journal Article
The Influence of Hepatic and Renal Impairment on the Pharmacokinetics of a Treatment for Herpes Zoster, Amenamevir (ASP2151): Phase 1, Open-Label, Single-Dose, Parallel-Group Studies
Kusawake, Tomohiro, Kowalski, Donna, Takada, Akitsugu, Kato, Kota, Katashima, Masataka, Keirns, James J., Lewand, Michaelene, Lasseter, Kenneth C., Marbury, Thomas C., Preston, Richard A.
Published in Advances in therapy (01.12.2017)
Published in Advances in therapy (01.12.2017)
Get full text
Journal Article
Effects of Food Intake on the Pharmacokinetic Properties of Mirabegron Oral Controlled-Absorption System: A Single-Dose, Randomized, Crossover Study in Healthy Adults
Lee, Jennifer, BSc, Zhang, Wenhui, PhD, Moy, Selina, BSc, Kowalski, Donna, MSc, Kerbusch, Virginie, PhD, van Gelderen, Marcel, PhD, Sawamoto, Taiji, PhD, Grunenberg, Nicole, MD, Keirns, James, PhD
Published in Clinical therapeutics (01.03.2013)
Published in Clinical therapeutics (01.03.2013)
Get full text
Journal Article
Importance of subject-specific QT/RR curvatures in the design of individual heart rate corrections of the QT interval
Malik, Marek, PhD, MD, Hnatkova, Katerina, PhD, Kowalski, Donna, MS, Keirns, James J., PhD, van Gelderen, E. Marcel, PhD
Published in Journal of electrocardiology (01.11.2012)
Published in Journal of electrocardiology (01.11.2012)
Get full text
Journal Article
Role of Cytochrome P450 Isoenzymes 3A and 2D6 in the In Vivo Metabolism of Mirabegron, a β3-Adrenoceptor Agonist
Lee, Jennifer, Moy, Selina, Meijer, John, Krauwinkel, Walter, Sawamoto, Taiji, Kerbusch, Virginie, Kowalski, Donna, Roy, Michael, Marion, Alan, Takusagawa, Shin, van Gelderen, Marcel, Keirns, James
Published in Clinical drug investigation (01.06.2013)
Published in Clinical drug investigation (01.06.2013)
Get full text
Journal Article
Are QTc interval changes after meal intake a reasonable method to prove assay sensitivity in thorough QT studies?
Hnatkova, Katerina, PhD, Kowalski, Donna, MSc, Keirns, James J., PhD, van Gelderen, E. Marcel, PhD, Malik, Marek, PhD, MD
Published in Journal of electrocardiology (01.03.2015)
Published in Journal of electrocardiology (01.03.2015)
Get full text
Journal Article
Time-Dependent Inhibitory Effects of (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-1,14-Dihydroxy-12-(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl-23,25-dimethoxy-13,19,21,27-tetramethyl-17-(2-oxopropyl)-11,28-dioxa-4-azatricyclo[22.3.1.04.9]octacos-18-ene-2,3,10,16-tetrone (FK1706), a Novel Nonimmunosuppressive Immunophilin Ligand, on CYP3A4/5 Activity in Humans in Vivo and in Vitro
MINEMATSU, Tsuyoshi, LEE, Jennifer, JIUHONG ZHA, MOY, Selina, KOWALSKI, Donna, HORI, Katsuyuki, ISHIBASHI, Koji, USUI, Takashi, KAMIMURA, Hidetaka
Published in Drug metabolism and disposition (01.02.2010)
Published in Drug metabolism and disposition (01.02.2010)
Get full text
Journal Article
Population Pharmacokinetics of Isavuconazole from Phase 1 and Phase 3 (SECURE) Trials in Adults and Target Attainment in Patients with Invasive Infections Due to Aspergillus and Other Filamentous Fungi
Desai, Amit, Kovanda, Laura, Kowalski, Donna, Lu, Qiaoyang, Townsend, Robert, Bonate, Peter L
Published in Antimicrobial agents and chemotherapy (01.09.2016)
Published in Antimicrobial agents and chemotherapy (01.09.2016)
Get full text
Journal Article
Isavuconazole absorption following oral administration in healthy subjects is comparable to intravenous dosing, and is not affected by food, or drugs that alter stomach pH
Schmitt-Hoffmann, Anne, Desai, Amit, Kowalski, Donna, Pearlman, Helene, Yamazaki, Takao, Townsend, Robert
Published in International journal of clinical pharmacology and therapeutics (01.08.2016)
Published in International journal of clinical pharmacology and therapeutics (01.08.2016)
Get full text
Journal Article
Pharmacokinetic Evaluation of CYP3A4‐Mediated Drug‐Drug Interactions of Isavuconazole With Rifampin, Ketoconazole, Midazolam, and Ethinyl Estradiol/Norethindrone in Healthy Adults
Townsend, Robert, Dietz, Albert, Hale, Christine, Akhtar, Shahzad, Kowalski, Donna, Lademacher, Christopher, Lasseter, Kenneth, Pearlman, Helene, Rammelsberg, Diane, Schmitt‐Hoffmann, Anne, Yamazaki, Takao, Desai, Amit
Published in Clinical pharmacology in drug development (01.01.2017)
Published in Clinical pharmacology in drug development (01.01.2017)
Get full text
Journal Article