Peter L Bonate
Affiliation: Genzyme Corporation
- Discovery and development of clofarabine: a nucleoside analogue for treating cancerPeter L Bonate
Genzyme, 4545 Horizon Hill Boulevard, San Antonio, Texas 78229, USA
Nat Rev Drug Discov 5:855-63. 2006..It is the first such drug to be approved for paediatric leukaemia in more than a decade, and the first to receive approval for paediatric use before adult use...
- Recommended reading in population pharmacokinetic pharmacodynamicsPeter L Bonate
Genzyme Corporation, 4545 Horizon Hill Blvd, San Antonio, TX, USA
AAPS J 7:E363-73. 2005..After reading the articles in the list, it is believed that the reader will have a broad overview of the field and have a sound foundation for more-detailed reading of the literature...
- The distribution, metabolism, and elimination of clofarabine in ratsPeter L Bonate
Genzyme Oncology, San Antonio, TX 78229, USA
Drug Metab Dispos 33:739-48. 2005..In rat, dog, and human hepatocytes, 95, 96, and 99.8% [14C]clofarabine remained, respectively, after 6 h of incubation. Eleven metabolites were observed, with the largest constituting 2.5% of the radioactivity...
- Pharmacokinetics in mice implanted with xenografted tumors after intravenous administration of tasidotin (ILX651) or its carboxylate metabolitePeter L Bonate
Genzyme Corporation, 4545 Horizon Hill Blvd, San Antonio, TX 78229, USA
AAPS J 9:E378-87. 2007....
- Population pharmacokinetics of clofarabine and its metabolite 6-ketoclofarabine in adult and pediatric patients with cancerPeter L Bonate
Genzyme Corporation, 4545 Horizon Hill Boulevard, San Antonio, TX 78229, USA
Cancer Chemother Pharmacol 67:875-90. 2011..9 h (range 3.9 to 6.2 h). No accumulation of 6-ketoclofarabine was observed with predose samples all below the limit of quantification on Days 8 and 15. Further monitoring of 6-ketoclofarabine is not required in future studies...
- Population pharmacokinetics of clofarabine, a second-generation nucleoside analog, in pediatric patients with acute leukemiaPeter L Bonate
ILEX Products, 4545 Horizon Hill Boulevard, San Antonio, TX 78229, USA
J Clin Pharmacol 44:1309-22. 2004..The results confirm that clofarabine should continue being dosed on a per-squaremeter or per-body-weight basis...
- Safety, tolerability, and pharmacokinetics of eliglustat tartrate (Genz-112638) after single doses, multiple doses, and food in healthy volunteersM Judith Peterschmitt
Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142, USA
J Clin Pharmacol 51:695-705. 2011..Steady state was reached ~60 hours after bid dosing. Higher drug exposure occurred in slower CYP2D6 metabolizers. Based on favorable results in healthy participants, a phase 2 trial of eliglustat tartrate was initiated in GD1 patients...
- Covariate detection in population pharmacokinetics using partially linear mixed effects modelsPeter L Bonate
Genzyme Corp, San Antonio, Texas 78229, USA
Pharm Res 22:541-9. 2005..To introduce partially linear mixed effects models (PLMEMs), to illustrate their use, and to compare the power and Type I error rate in detecting a covariate effect with nonlinear mixed effects modeling using NONMEM...
- Population pharmacokinetics of APOMINE: a meta-analysis in cancer patients and healthy malesPeter L Bonate
ILEX Products, 4545 Horizon Hill Blvd, San Antonio, TX 78229, USA
Br J Clin Pharmacol 58:142-55. 2004....
- Phase I and pharmacokinetic study of the dolastatin-15 analogue tasidotin (ILX651) administered intravenously on days 1, 3, and 5 every 3 weeks in patients with advanced solid tumorsCasey Cunningham
Tyler Cancer Center, Texas, USA
Clin Cancer Res 11:7825-33. 2005..4 mg/m(2). The favorable toxicity profile of tasidotin compared with other antitubulin agents, including other dolastatin analogues, and its novel mechanism of action support further disease-directed evaluation of this agent...
- Clinical and pharmacokinetic study of clofarabine in chronic lymphocytic leukemia: strategy for treatmentVarsha Gandhi
Department of Experimental Therapeutics, The University of Texas M D Anderson Cancer Center, Houston, Texas 77030, USA
Clin Cancer Res 12:4011-7. 2006..The present study was conducted to determine the efficacy and cellular pharmacology during clinical trials of single-agent clofarabine in CLL...
- Phase I and pharmacokinetic study of tasidotin hydrochloride (ILX651), a third-generation dolastatin-15 analogue, administered weekly for 3 weeks every 28 days in patients with advanced solid tumorsAlain C Mita
Institute for Drug Development, Cancer Therapy and Research Center and University of Texas Health Science Center, San Antonio 78229, USA
Clin Cancer Res 12:5207-15. 2006..v. infusion weekly for 3 weeks every 4 weeks...
- A phase I study of the dolastatin-15 analogue tasidotin (ILX651) administered intravenously daily for 5 consecutive days every 3 weeks in patients with advanced solid tumorsScot Ebbinghaus
Arizona Cancer Center, University of Arizona, Tucson, USA
Clin Cancer Res 11:7807-16. 2005....
- Plasma and cerebrospinal fluid pharmacokinetics of clofarabine in nonhuman primatesStacey L Berg
Texas Children s Cancer Center, Department of Surgery, Baylor College of Medicine, Houston, Texas 77030, USA
Clin Cancer Res 11:5981-3. 2005..We studied the pharmacokinetics and cerebrospinal fluid penetration of clofarabine in a nonhuman primate model...