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Drug Development Publications

  • The population approach: FDA experience.
    • Ette EI, Miller R, Gillespie WR, Huang SM, Lesko L, Williams R. The population approach: FDA experience. Proceedings of conference on the population approach: measuring and managing variability in response, concentration and dose. European Cooperation in the Field of Scientific and Technical Research (Project COST B1, round III), 1997; pp 271 - 275.
  • Guidance on Population Pharmacokinetics for Industry, Food and Drug Administration
  • Population pharmacokinetics: a regulatory perspective.
    • Sun H, Fadiran EO, Jones CD, Lesko L, Huang SM, Higgins K, Hu C, Machado S, Maldonado S, Williams R, Hossain M, Ette EI. Population pharmacokinetics: a regulatory perspective. Clin Pharmacokinet 1999; 37: 41 - 58. Williams P, Ette EI. The role of population pharmacokinetics in drug development in the light of the FDA Guidance on population pharmacokinetics. Clin Pharmacokinet 2000; 39: 385 - 395.
  • The role of population pharmacokinetics in drug development in the light of the FDA Guidance on population pharmacokinetics.
    • Williams P, Ette EI. The role of population pharmacokinetics in drug development in the light of the FDA Guidance on population pharmacokinetics. Clin Pharmacokinet 2000; 39: 385 - 395.
  • Drug development: a rational approach.
    • Ette EI. Garg V, Jayaraj A. Drug development: a rational approach. In: Pharmacokinetics in Drug Development (Volume 2). Bonate P, Howard D (eds). AAPS Press. 2004, pp 3 –36.
  • Pharmacometrics: Impacting Drug Development and Pharmacotherapy.
    • Williams PJ, Ette EI. Pharmacometrics: Impacting Drug Development and Pharmacotherapy. In: Pharmacometrics: the Science of Quantitative Pharmacology. Ette EI, Williams PJ (eds). Hoboken: John Wiley & Sons, 2007, pp 1 – 21.
  • Biomarkers in drug development and pharmacometric modeling.
    • Williams PJ, Ette EI. Biomarkers in drug development and pharmacometric modeling. In: Pharmacometrics: the Science of Quantitative Pharmacology. Ette EI, Williams PJ (eds). Hoboken: John Wiley & Sons, 2007, pp 457 – 471.
  • A Rational Approach to Drug Development: The Exploratory Phase.
    • Ette EI, Garg V, Jayaraj A. A Rational Approach to Drug Development: The Exploratory Phase. Clin Res Regul Affairs 2004; 21: 155 –177.
  • A Rational Approach to Drug Development: The Confirmatory Phase.
    • Ene I. Ette, Varun Garg, Angrew Jayaraj. A Rational Approach to Drug Development: The Confirmatory Phase. Clin Res Regul Affairs 2005; 22 (3-4): 103 – 118.
  • The application of pharmacometrics to cardiovascular drug development.
    • Williams P, Desai A, Ette EI. The application of pharmacometrics to cardiovascular drug development. In: Cardiac Drug Development Guide. Pugsley MK (ed). Totowa: Humana Press. 2003, pp 365 – 387.
  • Pharmacometric knowledge based oncology drug development.
    • Williams P, Uchizono J, Ette EI. Pharmacometric knowledge based oncology drug development. In: Pharmacokinetics and Pharmacodynamics of Anti-Cancer Drugs. Figg W (ed). Humana Press. 2003, pp 149 – 168.
  • Effectiveness and tolerability of a once daily amprenavir/ritonavir containing highly active antiretroviral therapy in antiretroviral- naïve patients at risk for non-adherence
    • Jayaweera DT, Kolber MA, Brill M, Tanner T, Campo R, Rodriguez A, Chu H-M, and Garg V. Effectiveness and tolerability of a once daily amprenavir/ritonavir containing highly active antiretroviral therapy in antiretroviral- naïve patients at risk for non-adherence: 48-week results after 24 weeks of directly observed therapy. HIV Med 2004; 5:364-370.
  • Dynamic Hepatitis C Virus Genotypic and Phenotypic Changes in Patients Treated With the Protease Inhibitor Telaprevir.
    • Sharrazin C, Kieffer L, Bartels D, Hanzelka B, Muh U, Welker M, Wincheringer D, Zhou Y, Chu H-M , Lin C,  Weegink CJ, Reesink HM, Zeuzem S, Kwong A. Dynamic Hepatitis C Virus Genotypic and Phenotypic Changes in Patients Treated With the Protease Inhibitor Telaprevir.  Gastroenterology 2007;  132: 1767-1777, 2007
  • Antiviral activity of telaprevir (VX-950) and peginterferon alfa-2a in patients with hepatitis C.
    • Forestier N, Reesink HW, Weegink C, McNair L, Kieffer T, Chu H-M , Purdy S, Jansen P, Zeuzem S. Antiviral activity of telaprevir (VX-950) and peginterferon alfa-2a in patients with hepatitis C. Hepatoology 2007;  46(3) 640-648.
  • Initial Results of a 14-day Study of the Hepatitis C Virus Inhibitor Protease VX-950, in Combination with Peginterferon-Alpha-2a.
    • Reesink HM, Forestier N, Weegink CJ, Zeuzem S, McNair L, Purdy S , Chu H-M, Jansen PLM. Initial Results of a 14-day Study of the Hepatitis C Virus Inhibitor Protease VX-950, in Combination with Peginterferon-Alpha-2a.  Hepatoology 2006;  44(S2) S272.
  • Antiviral activity of telaprevir (VX-950) and peginterferon alfa-2a in patients with hepatitis Hepatoology. 
    • Forestier CN, Reesink HW, Weegink C, McNair L, Kieffer T, Chu H-M, Purdy S, Jansen P, Zeuzem S. Antiviral activity of telaprevir (VX-950) and peginterferon alfa-2a in patients with hepatitis Hepatoology.  46(3) 640-648, 2007.
  • A randomized, double-blind, placebo-controlled dose-escalation trial of merimepodip (VX-497) and interferon-™ in previously untreated patients with chronic hepatitis C.
    • McHutchison JG, Schiffman ML, Cheung RC, Gordon SC, Wright TL, Pottage Jr. JC, McNair L, Ette E, Moseley S, Alam J. A randomized, double-blind, placebo-controlled dose-escalation trial of merimepodip (VX-497) and interferon-™ in previously untreated patients with chronic hepatitis C. Antiviral Therapy 2005, 10: 635 – 643.
  • Safety and efficacy of the multiple drug resistance inhibitor biricodar (VX-710) with concurrent doxorubicin in patients with anthracycline – resistant advanced soft tissue sarcoma.
    • Bramwell VHC, Morris D, Ernst DS, Hings I., Blackstein M, Venner PM, Ette E, Harding MW, Wasman A, Demetri G. Safety and efficacy of the multiple drug resistance inhibitor biricodar (VX-710) with concurrent doxorubicin in patients with anthracycline – resistant advanced soft tissue sarcoma. Clin Cancer Res 2002; 8(2): 383-393.
  • Safety and efficacy of the multidrug resistance inhibitor incel (bricodar; VX-710) in combination with paclitaxel for advanced breast cancer refractory to paclitaxel.
    • Toppmeyer D, Seidman AD, Pollak M, Russell C, Tkaczuk K, Verma S, Overmoyer B, Garg V, Ette E, Harding MW, Demetri G. Safety and efficacy of the multidrug resistance inhibitor incel (bricodar; VX-710) in combination with paclitaxel for advanced breast cancer refractory to paclitaxel. Clin Cancer Res 2002; 8: 670 – 678.
  • Safety and efficacy of the MDR inhibitor Incel ™ (bricodar, VX-710) in combination with mitoxantrone and prednisone in hormone refractory prostate cancer.
    • Rago RP, Einstein Jr. A, Lush R, Beer TM, Ko Y-J, Henner D, Bubley G, Merica EA, Garg V, Ette EI, Harding MW, Dalton WS. Safety and efficacy of the MDR inhibitor Incel ™ (bricodar, VX-710) in combination with mitoxantrone and prednisone in hormone refractory prostate cancer. Cancer Chemother Pharmacol 2003; 51: 297 – 305.
  • A phase II study of the MDR inhibitor bricodar (Incel ™) and paclitaxel in women with advanced ovarian cancer refractory to paclitaxel therapy.
    • Seiden MV, Swenerton KD, Matulonis U, Campos S, Rose P, Batist G, Ette E, Garg V, Fuller A, Harding MW, Charpentier D. A phase II study of the MDR inhibitor bricodar (Incel ™) and paclitaxel in women with advanced ovarian cancer refractory to paclitaxel therapy. Genecol Oncol 2002; 86: 302 – 310.
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