Search Results - "Rogge, Mark C."

Strategies and Recommendations for Using a Data‐Driven and Risk‐Based Approach in the Selection of First‐in‐Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment by Leach, Michael W., Clarke, David O., Dudal, Sherri, Han, Chao, Li, Chunze, Yang, Zheng, Brennan, Frank R., Bailey, Wendy J., Chen, Yingxue, Deslandes, Antoine, Loberg, Lise I., Mayawala, Kapil, Rogge, Mark C., Todd, Marque, Chemuturi, Nagendra V.

“…Various approaches to first‐in‐human (FIH) starting dose selection for new molecular entities (NMEs) are designed to minimize risk to trial subjects. One…”
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Interferon beta assessment in non-Chinese and Chinese subjects: Pharmacokinetics and pharmacodynamic activity of an endogenous cytokine are not race dependent by Rogge, Mark C., Liu, Yun, Galluppi, Gerald R.

“…Interferon beta‐1a (IFNβ‐1a) is a first‐line therapy for relapsing multiple sclerosis when administered as 30 mcg intramuscularly (IM) once weekly. This…”
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Clinical pharmacology, creating current and future success in drug development by Rogge, Mark C., Dresser, Mark, Fossler, Michael, Heald, Donald, Stoch, S. Aubrey, Vanevski, Konstantina M., Bello, Akintunde

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Preclinical safety of recombinant human thrombin by Heffernan, Jane K., Ponce, Rafael A., Zuckerman, Linda A., Volpone, John P., Visich, Jennifer, Giste, Erika E., Jenkins, Nancy, Boster, Dan, Pederson, Susan, Knitter, Glenn, Palmer, Thomas, Wills, Margaret, Early, Richard J., Rogge, Mark C.

“…Recombinant human thrombin (rhThrombin) is being developed as an alternative to thrombin products purified from pooled human or bovine plasma, which are…”
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Preclinical Safety and Pharmacokinetics of Recombinant Human Factor XIII by Ponce, Rafael A., Visich, Jennifer E., Heffernan, Jane K., Lewis, Kenneth B., Pederson, Susan, Lebel, Elen, Andrews-Jones, Lydia, Elliott, Glenn, Palmer, Thomas E., Rogge, Mark C.

“…Factor XIII (FXIII) is a thrombin-activated protransglutaminase responsible for fibrin clot stabilization and longevity. Deficiency in FXIII is associated with…”
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The theophylline-enoxacin interaction: I. Effect of enoxacin dose size on theophylline disposition by Rogge, M C, Solomon, W R, Sedman, A J, Welling, P G, Toothaker, R D, Wagner, J G

“…Theophylline interacts pharmacokinetically with a variety of other drugs. Recently enoxacin was found to change theophylline's disposition. In a four-subject,…”
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Effect of food and a monoglyceride emulsion formulation on danazol bioavailability by Charman, W N, Rogge, M C, Boddy, A W, Berger, B M

“…The bioavailability of a single 100-mg dose of danazol delivered from the commercial formulation (hard gelatin capsule) and from an experimental lipid emulsion…”
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Absorption of danazol after administration to different sites of the gastrointestinal tract and the relationship to single- and double-peak phenomena in the plasma profiles by Charman, W N, Rogge, M C, Boddy, A W, Barr, W H, Berger, B M

“…The absorption of danazol (100 mg) after oral or intraintestinal administration to the proximal jejunum or proximal ileum has been studied in healthy female…”
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The theophylline-enoxacin interaction: II. Changes in the disposition of theophylline and its metabolites during intermittent administration of enoxacin by Rogge, M C, Solomon, W R, Sedman, A J, Welling, P G, Koup, J R, Wagner, J G

“…The pharmacokinetics of theophylline and its three major metabolites, 3-methylxanthine, 1-methylurate, and 1,3-dimethylurate, were studied during intermittent…”
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Pharmacokinetic profile of levofloxacin following once-daily 500-milligram oral or intravenous doses by CHIEN, S.-C, ROGGE, M. C, GISCLON, L. G, CURTIN, C, WONG, F, NATARAJAN, J, WILLIAMS, R. R, FOWLER, C. L, CHEUNG, W. K, CHOW, A. T

“…Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon…”
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TACI-Ig Does Not Affect C57Bl/6 Murine Response to Influenza Reinfection by Ponce, Rafael A., Burleson, Florence, Roque, Richard, Hill, Julie, Cabrit, Mathilde, Broly, Herve, Rogge, Mark C.

“…TACI-Ig, a soluble receptor Fc fusion protein with high affinity for BLyS and APRIL, is associated with decreased B-cells and reduced circulating…”
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IL-21 Improves Rituximab-Mediated B Cell Depletion by Hughes, Steven D., Ponce, Rafael A., Krejsa, Cecile, Frings, Werner, Bartsch, Stephanie, Hill, Julie P., Rogge, Mark C.

“…IL-21 is a cytokine produced by activated CD4+ T cells that augments the growth, survival, and function of NK, T and phagocytic cells. IL-21 also plays an…”
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Self-emulsifying drug delivery systems: formulation and biopharmaceutic evaluation of an investigational lipophilic compound by Charman, S A, Charman, W N, Rogge, M C, Wilson, T D, Dutko, F J, Pouton, C W

“…Self-emulsifying drug delivery systems (SEDDSs) represent a possible alternative to traditional oral formulations of lipophilic compounds. In the present…”
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Integration of pharmacokinetic and pharmacodynamic studies in the discovery, development, and review of protein therapeutic agents: A conference report by Galluppi, Gerald R., Rogge, Mark C., Roskos, Lorin K., Lesko, Lawrence J., Green, Martin D., Feigal, David W., Peck, Carl C.

“…Clinical Pharmacology & Therapeutics (2001) 69, 387–399; doi: 10.1067/mcp.2001.115455…”
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Pharmacokinetics/dynamics of 5c8, a monoclonal antibody to CD154 (CD40 ligand) suppression of an immune response in monkeys by Gobburu, J V, Tenhoor, C, Rogge, M C, Frazier, Jr, D E, Thomas, D, Benjamin, C, Hess, D M, Jusko, W J

“…The pharmacokinetics and pharmacodynamics (PK/PD) of chimeric (Ch5c8) and humanized (Hu5c8) 5c8, a monoclonal antibody that binds CD154 (CD40 ligand), thus…”
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Comparative pharmacokinetics and pharmacodynamics of recombinant human interferon beta-1a after intramuscular and subcutaneous administration by Rogge, Mark C., Simonian, Nancy A., Jones, Wendy E.

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Bioavailability of hydrochlorothiazide from tablets and suspensions by Patel, R B, Patel, U R, Rogge, M C, Shah, V P, Prasad, V K, Selen, A, Welling, P G

“…The bioavailability of hydrochlorothiazide was determined following single oral 25-, 50-, 100-, and 200-mg tablet and suspension doses in 12 healthy male…”
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Bioavailability of hydrocortisone from commercial 20-mg tablets by Patel, R B, Rogge, M C, Selen, A, Goehl, T J, Shah, V P, Prasad, V K, Welling, P G

“…The relative bioavailability of hydrocortisone was determined from four different 20-mg tablet formulations and one suspension in 15 healthy male volunteers;…”
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A pharmacokinetic comparison of cephalexin and cefadroxil using HPLC assay procedures by Welling, P G, Selen, A, Pearson, J G, Kwok, F, Rogge, M C, Ifan, A, Marrero, D, Craig, W A, Johnson, C A

“…The pharmacokinetics of cephalexin and cefadroxil were compared following single 500 mg oral doses to 12 healthy male volunteers. Doses were administered after…”
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Single dose and steady-state pharmacokinetics of adinazolam after oral administration to man by Wagner, J G, Rogge, M C, Natale, R B, Albert, K S, Szpunar, G J

“…An aqueous solution containing 1 mg of adinazolam mesylate per ml was administered orally as a single dose (40 mg) and with loading doses followed by hourly…”
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