Mahesh N Samtani

Summary

Affiliation: Johnson and Johnson Pharmaceutical Research and Development
Country: USA

Publications

  1. doi request reprint Simple pharmacometric tools for oral anti-diabetic drug development: competitive landscape for oral non-insulin therapies in type 2 diabetes
    Mahesh N Samtani
    Clinical Pharmacology Advanced PK PD Modeling and Simulation, Johnson and Johnson Pharmaceutical Research and Development, Raritan, New Jersey 08869, USA
    Biopharm Drug Dispos 31:162-77. 2010
  2. pmc Disease progression model in subjects with mild cognitive impairment from the Alzheimer's disease neuroimaging initiative: CSF biomarkers predict population subtypes
    Mahesh N Samtani
    Johnson and Johnson Pharmaceutical Research and Development, Clinical Pharmacology Department, Raritan, New Jersey 08869, USA
    Br J Clin Pharmacol 75:146-61. 2013
  3. doi request reprint An improved model for disease progression in patients from the Alzheimer's disease neuroimaging initiative
    Mahesh N Samtani
    Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ, USA
    J Clin Pharmacol 52:629-44. 2012
  4. doi request reprint Pharmacokinetic and pharmacodynamic modeling of pegylated thrombopoietin mimetic peptide (PEG-TPOm) after single intravenous dose administration in healthy subjects
    Mahesh N Samtani
    Clinical Pharmacology, Advanced PK PD Modeling and Simulation, Johnson and Johnson Pharmaceutical R and D, 920 Route 202, PRD 2723, Raritan, NJ 08869, USA
    J Clin Pharmacol 49:336-50. 2009
  5. doi request reprint Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-monthly, long-acting formulation of an atypical antipsychotic
    Mahesh N Samtani
    Clinical Pharmacology, Advanced PK PD Modeling and Simulation, Johnson and Johnson Pharmaceutical Research and Development, LLC, 920 Route 202, PRD 2723, Raritan, NJ 08869, USA
    Clin Pharmacokinet 48:585-600. 2009
  6. doi request reprint Dosing and switching strategies for paliperidone palmitate: based on population pharmacokinetic modelling and clinical trial data
    Mahesh N Samtani
    Johnson Johnson Pharmaceutical Research Development, L L C, Raritan, NJ, USA
    CNS Drugs 25:829-45. 2011
  7. doi request reprint A novel subject synchronization clinical trial design for Alzheimer's disease
    Timothy Schultz
    Janssen Pharmaceutical Companies of Johnson and Johnson, Raritan, NJ 08869, USA
    J Alzheimers Dis 31:507-16. 2012
  8. pmc The ADAS-Cog revisited: novel composite scales based on ADAS-Cog to improve efficiency in MCI and early AD trials
    Nandini Raghavan
    Janssen Pharmaceutical Companies of Johnson and Johnson, Raritan, NJ, USA
    Alzheimers Dement 9:S21-31. 2013
  9. pmc A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia
    Danielle Coppola
    Janssen Research and Development, LLC, Raritan, New Jersey, USA
    BMC Psychiatry 12:26. 2012
  10. pmc Pharmacokinetic-pharmacodynamic-model-guided doripenem dosing in critically ill patients
    Mahesh N Samtani
    Clinical Pharmacology, Advanced PK PD Modeling and Simulation, Johnson and Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ 08560, USA
    Antimicrob Agents Chemother 54:2360-4. 2010

Detail Information

Publications16

  1. doi request reprint Simple pharmacometric tools for oral anti-diabetic drug development: competitive landscape for oral non-insulin therapies in type 2 diabetes
    Mahesh N Samtani
    Clinical Pharmacology Advanced PK PD Modeling and Simulation, Johnson and Johnson Pharmaceutical Research and Development, Raritan, New Jersey 08869, USA
    Biopharm Drug Dispos 31:162-77. 2010
    ..8% or more and possess safety profiles similar to newer anti-diabetic agents. Thus, this study proposes a suite of simple yet powerful tools to guide type-2-diabetes drug development...
  2. pmc Disease progression model in subjects with mild cognitive impairment from the Alzheimer's disease neuroimaging initiative: CSF biomarkers predict population subtypes
    Mahesh N Samtani
    Johnson and Johnson Pharmaceutical Research and Development, Clinical Pharmacology Department, Raritan, New Jersey 08869, USA
    Br J Clin Pharmacol 75:146-61. 2013
    ....
  3. doi request reprint An improved model for disease progression in patients from the Alzheimer's disease neuroimaging initiative
    Mahesh N Samtani
    Johnson and Johnson Pharmaceutical Research and Development, Raritan, NJ, USA
    J Clin Pharmacol 52:629-44. 2012
    ....
  4. doi request reprint Pharmacokinetic and pharmacodynamic modeling of pegylated thrombopoietin mimetic peptide (PEG-TPOm) after single intravenous dose administration in healthy subjects
    Mahesh N Samtani
    Clinical Pharmacology, Advanced PK PD Modeling and Simulation, Johnson and Johnson Pharmaceutical R and D, 920 Route 202, PRD 2723, Raritan, NJ 08869, USA
    J Clin Pharmacol 49:336-50. 2009
    ....
  5. doi request reprint Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-monthly, long-acting formulation of an atypical antipsychotic
    Mahesh N Samtani
    Clinical Pharmacology, Advanced PK PD Modeling and Simulation, Johnson and Johnson Pharmaceutical Research and Development, LLC, 920 Route 202, PRD 2723, Raritan, NJ 08869, USA
    Clin Pharmacokinet 48:585-600. 2009
    ..To characterize the population pharmacokinetics of paliperidone after intramuscular administration of its long-acting palmitate ester at various doses and at two different injection sites (deltoid and gluteal muscle)...
  6. doi request reprint Dosing and switching strategies for paliperidone palmitate: based on population pharmacokinetic modelling and clinical trial data
    Mahesh N Samtani
    Johnson Johnson Pharmaceutical Research Development, L L C, Raritan, NJ, USA
    CNS Drugs 25:829-45. 2011
    ..Population PK modelling presented in this review has helped provide practical guidance for administering this novel LAI antipsychotic...
  7. doi request reprint A novel subject synchronization clinical trial design for Alzheimer's disease
    Timothy Schultz
    Janssen Pharmaceutical Companies of Johnson and Johnson, Raritan, NJ 08869, USA
    J Alzheimers Dis 31:507-16. 2012
    ....
  8. pmc The ADAS-Cog revisited: novel composite scales based on ADAS-Cog to improve efficiency in MCI and early AD trials
    Nandini Raghavan
    Janssen Pharmaceutical Companies of Johnson and Johnson, Raritan, NJ, USA
    Alzheimers Dement 9:S21-31. 2013
    ..A wealth of data exists in ADAS-Cog from both historical trials and contemporary longitudinal natural history studies that can provide insights about parts of the scale that may be better suited for MCI and early AD trials...
  9. pmc A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia
    Danielle Coppola
    Janssen Research and Development, LLC, Raritan, New Jersey, USA
    BMC Psychiatry 12:26. 2012
    ..This study evaluates safety and tolerability, as well as pharmacokinetics, of the highest marketed dose of PP (150 mg eq. [234 mg]) in stable patients with schizophrenia over a 1-year period...
  10. pmc Pharmacokinetic-pharmacodynamic-model-guided doripenem dosing in critically ill patients
    Mahesh N Samtani
    Clinical Pharmacology, Advanced PK PD Modeling and Simulation, Johnson and Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ 08560, USA
    Antimicrob Agents Chemother 54:2360-4. 2010
    ..Results of pharmacokinetics/pharmacodynamics (PK/PD) modeling can guide dose optimization, thereby potentially increasing the clinical efficacy of doripenem against serious Gram-negative bacterial infections...
  11. pmc Expansion of guidance for the day 8 initiation dose of paliperidone palmitate to avoid a missed dose
    Mahesh N Samtani
    Janssen Research and Development, LLC, NJ, USA
    Neuropsychiatr Dis Treat 9:721-30. 2013
    ..Recently, expansion of the day 8 dosing window from ±2 to ±4 days has been approved in the United States based on results obtained from the model-based simulations and review of safety data presented here...
  12. pmc Pharmacodynamic profiling of ceftobiprole for treatment of complicated skin and skin structure infections
    Holly Kimko
    Johnson and Johnson Pharmaceutical Research and Development, LLC, 920 Route 202 South, Raritan, NJ 08869, USA
    Antimicrob Agents Chemother 53:3371-4. 2009
    ..A ceftobiprole regimen of 500 mg every 8 h as a 2-h infusion has a high probability of achieving a target of >or=30 or >or=50% T>MIC for patients with cSSSI due to gram-positive and gram-negative pathogens...
  13. doi request reprint Mixed-effects beta regression for modeling continuous bounded outcome scores using NONMEM when data are not on the boundaries
    Xu Steven Xu
    Model Based Drug Development, Janssen Research and Development, 920 Route 202, Raritan, NJ, USA
    J Pharmacokinet Pharmacodyn 40:537-44. 2013
    ..In addition, the NONMEM run time for the mixed beta regression models appeared to be much shorter compared to SAS, i.e., 1-2 versus 20-40 s for the model and data used in the manuscript. ..
  14. pmc Management of antipsychotic treatment discontinuation and interruptions using model-based simulations
    Mahesh N Samtani
    Janssen Research and Development, Raritan, NJ, USA
    Clin Pharmacol 4:25-40. 2012
    ..These pharmacokinetic model-based simulations analyze predicted antipsychotic plasma concentrations in nonadherence and treatment interruption scenarios and with treatment reinitiation...
  15. pmc Doripenem dosing recommendations for critically ill patients receiving continuous renal replacement therapy
    Mahesh N Samtani
    Clinical Pharmacology, Janssen Research and Development, L L C, 920 Route 202, Raritan, NJ 08869, USA
    ISRN Pharmacol 2012:782656. 2012
    ..This work was conducted to fulfill a health authority request and resulted in the addition of dosing recommendations to the Doribax Summary of Product Characteristics...
  16. pmc Population pharmacokinetics of doripenem based on data from phase 1 studies with healthy volunteers and phase 2 and 3 studies with critically ill patients
    Partha Nandy
    Clinical Pharmacology, Advanced PK PD Modeling and Simulation, Johnson and Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ 08560, USA
    Antimicrob Agents Chemother 54:2354-9. 2010
    ....