I Mahmood

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Interspecies scaling: predicting oral clearance in humans
    Iftekhar Mahmood
    Division of Pharmaceutical Evaluation 1 HFD 860, Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Rockville, MD 20852, USA
    Am J Ther 9:35-42. 2002
  2. ncbi request reprint A Bayesian approach for the estimation of pharmacokinetic parameters in children
    Iftekhar Mahmood
    Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Woodmont Office Center I, Suite 200N, 1401 Rockville Pike, Rockville, MD 20852, USA
    Am J Ther 10:88-92. 2003
  3. ncbi request reprint Impact of truncated area under the curve on failed bioequivalence studies: a computer simulation analysis
    Iftekhar Mahmood
    Division of Clinical Trial Design and Analysis, Office of Therapeutic Research and Review, Clinical Pharmacology and Toxicology Branch, Food and Drug Administration, Rockville, MD 20852, USA
    Drug Metabol Drug Interact 20:77-83. 2004
  4. ncbi request reprint The correction factors do help in improving the prediction of human clearance from animal data
    Iftekhar Mahmood
    J Pharm Sci 94:940-5; author reply 946-7. 2005
  5. ncbi request reprint Prediction of human drug clearance from animal data: application of the rule of exponents and 'fu Corrected Intercept Method' (FCIM)
    Iftekhar Mahmood
    Clinical Pharmacology and Toxicology Branch HFD 579, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Woodmont Office Center II, Rockville, Maryland 20852, USA
    J Pharm Sci 95:1810-21. 2006
  6. ncbi request reprint Clinical pharmacokinetics and pharmacodynamics of selegiline. An update
    I Mahmood
    Division of Pharmaceutical Evaluation I, Food and Drug Administration, Rockville, Maryland, USA
    Clin Pharmacokinet 33:91-102. 1997
  7. ncbi request reprint Interspecies scaling of biliary excreted drugs: a comparison of several methods
    Iftekhar Mahmood
    Clinical Pharmacology and Toxicology Branch HFD 579, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Woodmont Office Center II, Rockville, Maryland 20852, USA
    J Pharm Sci 94:883-92. 2005
  8. ncbi request reprint Pharmacokinetic and pharmacodynamic considerations in the development of therapeutic proteins
    Iftekhar Mahmood
    Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Clin Pharmacokinet 44:331-47. 2005
  9. pmc Prediction of drug clearance in children from adults: a comparison of several allometric methods
    Iftekhar Mahmood
    Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Br J Clin Pharmacol 61:545-57. 2006
  10. ncbi request reprint Interspecies allometric scaling. Part I: prediction of clearance in large animals
    I Mahmood
    Clinical Pharmacology and Toxicology Branch HFD 579, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Rockville, MD 20852, USA
    J Vet Pharmacol Ther 29:415-23. 2006

Detail Information

Publications37

  1. ncbi request reprint Interspecies scaling: predicting oral clearance in humans
    Iftekhar Mahmood
    Division of Pharmaceutical Evaluation 1 HFD 860, Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Rockville, MD 20852, USA
    Am J Ther 9:35-42. 2002
    ..Data from 32 drugs were analyzed, and it was concluded that the oral clearance of drugs could be best predicted using one of the allometric equations...
  2. ncbi request reprint A Bayesian approach for the estimation of pharmacokinetic parameters in children
    Iftekhar Mahmood
    Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Woodmont Office Center I, Suite 200N, 1401 Rockville Pike, Rockville, MD 20852, USA
    Am J Ther 10:88-92. 2003
    ..The Bayesian method described here can be used to assess pharmacokinetic parameters in children, provided there is a prior knowledge of the pharmacokinetics of a drug in adult population...
  3. ncbi request reprint Impact of truncated area under the curve on failed bioequivalence studies: a computer simulation analysis
    Iftekhar Mahmood
    Division of Clinical Trial Design and Analysis, Office of Therapeutic Research and Review, Clinical Pharmacology and Toxicology Branch, Food and Drug Administration, Rockville, MD 20852, USA
    Drug Metabol Drug Interact 20:77-83. 2004
    ....
  4. ncbi request reprint The correction factors do help in improving the prediction of human clearance from animal data
    Iftekhar Mahmood
    J Pharm Sci 94:940-5; author reply 946-7. 2005
  5. ncbi request reprint Prediction of human drug clearance from animal data: application of the rule of exponents and 'fu Corrected Intercept Method' (FCIM)
    Iftekhar Mahmood
    Clinical Pharmacology and Toxicology Branch HFD 579, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Woodmont Office Center II, Rockville, Maryland 20852, USA
    J Pharm Sci 95:1810-21. 2006
    ..The advantages and disadvantages of these two methods are also discussed...
  6. ncbi request reprint Clinical pharmacokinetics and pharmacodynamics of selegiline. An update
    I Mahmood
    Division of Pharmaceutical Evaluation I, Food and Drug Administration, Rockville, Maryland, USA
    Clin Pharmacokinet 33:91-102. 1997
    ....
  7. ncbi request reprint Interspecies scaling of biliary excreted drugs: a comparison of several methods
    Iftekhar Mahmood
    Clinical Pharmacology and Toxicology Branch HFD 579, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Woodmont Office Center II, Rockville, Maryland 20852, USA
    J Pharm Sci 94:883-92. 2005
    ..The simple allometry and the monkey liver blood flow (MLBF) approaches gave almost similar results. For some drugs the simple allometry predicted clearance better than the MLBF approach and vice versa...
  8. ncbi request reprint Pharmacokinetic and pharmacodynamic considerations in the development of therapeutic proteins
    Iftekhar Mahmood
    Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Clin Pharmacokinet 44:331-47. 2005
    ..The relationship between pharmacokinetics and pharmacodynamics of therapeutic proteins is complex and in most cases is unclear. In many cases the mechanism and site of action are unknown for these compounds...
  9. pmc Prediction of drug clearance in children from adults: a comparison of several allometric methods
    Iftekhar Mahmood
    Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    Br J Clin Pharmacol 61:545-57. 2006
    ..75; and (iii) to propose a new approach (if any) based on the findings of the current evaluation...
  10. ncbi request reprint Interspecies allometric scaling. Part I: prediction of clearance in large animals
    I Mahmood
    Clinical Pharmacology and Toxicology Branch HFD 579, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Rockville, MD 20852, USA
    J Vet Pharmacol Ther 29:415-23. 2006
    ..For this reason, it is important to consider mechanisms for reducing the risk of extrapolation errors that can seriously affect target animal safety, therapeutic response, or the accuracy of withdrawal time predictions...
  11. ncbi request reprint Interspecies scaling of biliary excreted drugs
    Iftekhar Mahmood
    Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics HFD 860, Food and Drug Administration, Rockville, Maryland 20852, USA
    J Pharm Sci 91:1908-14. 2002
    ....
  12. ncbi request reprint Comparison of different reduced sampling approaches for the estimation of pharmacokinetic parameters for long half-life drugs in patients with renal or hepatic impairment
    I Mahmood
    Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Rockville, MD 20852, USA
    Int J Clin Pharmacol Ther 40:53-9. 2002
    ....
  13. ncbi request reprint Interspecies scaling: is a priori knowledge of cytochrome p450 isozymes involved in drug metabolism helpful in prediction of clearance in humans from animal data?
    I Mahmood
    Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Rockville, MD 20852, USA
    Drug Metabol Drug Interact 18:135-47. 2001
    ..There is no trend which indicates that the chances of accurate prediction of clearance for a given drug are comparatively higher or lower when they are metabolized by a particular isozyme...
  14. ncbi request reprint Can absolute oral bioavailability in humans be predicted from animals? A comparison of allometry and different indirect methods
    I Mahmood
    Division of Pharmaceutical Evaluation I HFD 860, Food and Drug Administration, Woodmont Office Center II, Rockville, MD 20852, USA
    Drug Metabol Drug Interact 16:143-55. 2000
    ..In conclusion, although the above-mentioned approaches do not accurately predict absolute bioavailability, a rough estimate of absolute bioavailability is possible using these approaches...
  15. ncbi request reprint Interspecies scaling of maximum tolerated dose of anticancer drugs: relevance to starting dose for phase I clinical trials
    I Mahmood
    Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics, U S Food and Drug Administration, Rockville, MD 20852, USA
    Am J Ther 8:109-16. 2001
    ..One third of the predicted MTD from interspecies scaling can be used as a starting dose in humans. This approach will save time and avoid many unnecessary steps in attaining MTD in humans...
  16. ncbi request reprint The pharmacokinetic principles behind scaling from preclinical results to phase I protocols
    I Mahmood
    Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Rockville, Maryland, USA
    Clin Pharmacokinet 36:1-11. 1999
    ..When a reasonable prediction of CL and Vc is made, t 1/2 beta may be predicted from the equation t 1/2 beta = 0.693 Vc/CL...
  17. ncbi request reprint A comparative study of allometric scaling with plasma concentrations predicted by species-invariant time methods
    I Mahmood
    Office of Clinical Pharmacology and Biopharmaceutics, Division of Pharmaceutical Evaluation I HFD 860, Food and Drug Administration, Rockville, MD 20852, USA
    Biopharm Drug Dispos 20:137-44. 1999
    ..Almost similar results in the pharmacokinetic parameters of the tested drugs were obtained by the allometric approach and by the species invariant time methods...
  18. ncbi request reprint Clinical pharmacokinetics and pharmacodynamics of buspirone, an anxiolytic drug
    I Mahmood
    Division of Pharmaceutical Evaluation I, Food and Drug Administration, Rockville, Maryland, USA
    Clin Pharmacokinet 36:277-87. 1999
    ..Rifampicin (rifampin) decreased the plasma concentrations of buspirone almost 10-fold...
  19. ncbi request reprint Allometric issues in drug development
    I Mahmood
    Office of Clinical Pharmacology and Biopharmaceutics, Division of Pharmaceutical Evaluation I HFD 860, Food and Drug Administration, Woodmont Office Center II, Room 4079, 1451 Rockville Pike, Rockville, Maryland 20852, USA
    J Pharm Sci 88:1101-6. 1999
    ..Overall, though interspecies scaling requires refinement and better understanding, the approach has lot of potential during the drug development process...
  20. ncbi request reprint Interspecies scaling of inhalational anesthetic potency minimum alveolar concentration (MAC): application of a correction factor for the prediction of MAC in humans
    I Mahmood
    Office of Clinical Pharmacology and Biopharmaceutics HFD 860, Division of Pharmaceutical Evaluation I, Food and Drug Administration, Rockville, MD 20852, USA
    Am J Ther 8:237-41. 2001
    ..The results of this study indicate that MAC may not be predicted in humans from animal data using simple allometry; however, applying a correction factor may significantly improve the prediction of MAC in humans from animal data...
  21. ncbi request reprint Interspecies allometric scaling: prediction of clearance in large animal species: part II: mathematical considerations
    M Martinez
    Division of Therapeutic Drugs for Food Animals HFV 130, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 29:425-32. 2006
    ..Ultimately, these considerations are used to generate recommendations regarding the data to be included in the allometric prediction of clearance in large animal species...
  22. doi request reprint Allometric scaling of clearance in dogs
    M Martinez
    Division of Therapeutic Drugs for Food Animals HFV 130, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, USA
    J Vet Pharmacol Ther 32:411-6. 2009
    ....
  23. ncbi request reprint Application of preclinical data to initiate the modified continual reassessment method for maximum tolerated dose-finding trials
    I Mahmood
    Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics (HFD-860, Food and Drug Administration (FDA, Rockville, Maryland, USA
    J Clin Pharmacol 41:19-24. 2001
    ..This approach can save time and avoid many unnecessary steps to attain MTD in humans if it could be applied prospectively...
  24. ncbi request reprint A comparison of two sparse sampling population pharmacokinetic approaches for the estimation of pharmacokinetic parameters in children
    I Mahmood
    Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics HFD 860, Food and Drug Administration, Woodmont Office Center II, Rockville, Pike, MD 20852, USA
    Int J Clin Pharmacol Ther 42:240-5. 2004
    ..The objectives of this study were to assess pharmacokinetic parameters (clearance, volume and half-life) in children using sparse sampling population as well as Bayesian (post hoc) approach...
  25. ncbi request reprint Designing first-in-human dose of coagulation factors: application of pharmacokinetic allometric scaling
    I Mahmood
    Office of Blood Review and Research OBRR, Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
    Haemophilia 20:32-8. 2014
    ..The suggested methods in this study are not only time and cost-effective but also provide rational alternatives to the somewhat arbitrary dose selection process for coagulation factors often used. ..
  26. doi request reprint Allometric extrapolation of factors VII, VIII and IX clearance in children from adults
    I Mahmood
    Office of Blood Review and Research, Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
    J Thromb Haemost 10:1609-13. 2012
    ..Under these circumstances, one would like to extrapolate PK parameters from adults or older children to neonates and infants. Allometric scaling is a method which can be used for PK extrapolation from adults to children...
  27. ncbi request reprint Pharmacokinetic allometric scaling of coagulation factors and tissue-type plasminogen activators
    I Mahmood
    Office of Blood Review and Research OBRR, Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville Pike, MD, USA
    Haemophilia 15:1109-17. 2009
    ..Two-species scaling can also be performed, but the accuracy of predicted parameters is less than three-species scaling...
  28. ncbi request reprint Impact of random and fixed (optimal) sampling approach on the Bayesian estimation of clearance
    I Mahmood
    Division of Clinical Trial Design and Analysis, Clin Pharmacol and Toxicology Branch, Ctr for Biologics Eval and Res, FDA, Rockville, MD 20852, USA
    Int J Clin Pharmacol Ther 41:392-6. 2003
    ..The objective of this study is to evaluate the impact of random and fixed sparse sampling approach on the Bayesian estimation of clearance...
  29. ncbi request reprint Center specificity in the limited sampling model (LSM): can the LSM developed from healthy subjects be extended to disease states?
    I Mahmood
    Division of Clinical Trial Design and Analysis, Clinical Pharmacology and Toxicology Branch, Center for Biologics Evaluation and Research, FDA, Rockville, MD 20852, USA
    Int J Clin Pharmacol Ther 41:517-23. 2003
    ..This characteristic of the LSM can be referred to as "center-specific". In this investigation, the LSM developed from the healthy subjects was used to predict AUC in patients with renal or hepatic impairment...
  30. ncbi request reprint Selegiline transdermal system Somerset
    Iftekhar Mahmood
    Division of Clinical Trial Design and Analysis, Center for Biologics Evaluation and Research, Food and Drug Administration, MD 20852, USA
    Curr Opin Investig Drugs 3:1230-3. 2002
    ..At this time, Somerset had scheduled a meeting with the FDA to review and clarify their comments [456735]. Selegiline will be co-promoted in the US by Watson, under the terms of a previous agreement [275389]...
  31. ncbi request reprint Application of allometric principles for the prediction of pharmacokinetics in human and veterinary drug development
    Iftekhar Mahmood
    Office of Blood Review and Research, Center for Biologic Evaluation and Research, Food and Drug Administration, 1451 Rockville Pike, MD, USA
    Adv Drug Deliv Rev 59:1177-92. 2007
    ..Overall, although interspecies scaling requires continuous refinement and better understanding, the rationale approach of interspecies scaling has a lot of potential during the drug development process...
  32. ncbi request reprint Prediction of drug clearance in children: impact of allometric exponents, body weight, and age
    Iftekhar Mahmood
    From the Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, USA
    Ther Drug Monit 29:271-8. 2007
    ..75 should be replaced by the exponent of the allometric equation developed for that drug...
  33. ncbi request reprint Prediction of clearance in humans from in vitro human liver microsomes and allometric scaling. A comparative study of the two approaches
    Iftekhar Mahmood
    Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Rockville, MD 20852, USA
    Drug Metabol Drug Interact 19:49-64. 2002
    ..On the other hand, the prediction of clearance in humans using allometric scaling combined with the 'rule of exponents' can provide comparatively better prediction of clearance in humans...
  34. ncbi request reprint Selection of the first-time dose in humans: comparison of different approaches based on interspecies scaling of clearance
    Iftekhar Mahmood
    Division of Clinical Trial Design and Analysis, Office of Therapeutic Research and Review, Clinical Pharmacology and Toxicology Branch, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
    J Clin Pharmacol 43:692-7. 2003
    ..This work demonstrates that animal pharmacokinetic data can be used to estimate a suitable human starting dose, provided the data have been obtained from a dose that produces no adverse effects...
  35. ncbi request reprint Comments on "a mathematical description of the functionality of correction factors used in allometry for predicting human drug clearance"
    Iftekhar Mahmood
    Drug Metab Dispos 34:507-9; author reply 510-1. 2006
    ..Even if one does not use the CF, the predicted clearance by the simple allometry will still vary by severalfold, depending on the species used in the scaling...
  36. ncbi request reprint Estimation of absorption rate constant (ka) following oral administration by Wagner-Nelson, Loo-Riegelman, and statistical moments in the presence of a secondary peak
    Iftekhar Mahmood
    Division of Clinical Trial Design and Analysis, Office of Therapeutic Research and Review, Clinical Pharmacology and Toxicology Branch, Food and Drug Administration, Rockville, MD 20852, USA
    Drug Metabol Drug Interact 20:85-100. 2004
    ....
  37. ncbi request reprint Interspecies scaling of protein drugs: prediction of clearance from animals to humans
    Iftekhar Mahmood
    Division of Clinical Trial Design and Analysis, Office of Therapeutic Research and Review, Food and Drug Administration, Woodmont Office Center I, Suite 200N, 1401 Rockville Pike, Rockville, Maryland 20852, USA
    J Pharm Sci 93:177-85. 2004
    ..It was found that more than two species are needed for a reliable prediction of clearance...