Lesko LJ - Search Results

1

Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics. FDA Individual Bioequivalence Working Group.

Patnaik RN, Lesko LJ, Chen ML, Williams RL. Patnaik RN, et al. Among authors: lesko lj. Clin Pharmacokinet. 1997 Jul;33(1):1-6. doi: 10.2165/00003088-199733010-00001. Clin Pharmacokinet. 1997. PMID: 9250419 No abstract available.

2

Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? FDA Biopharmaceutics Coordinating Committee.

Williams RL, Adams W, Chen ML, Hare D, Hussain A, Lesko L, Patnaik R, Shah V. Williams RL, et al. Eur J Drug Metab Pharmacokinet. 2000 Jan-Mar;25(1):7-12. doi: 10.1007/BF03190049. Eur J Drug Metab Pharmacokinet. 2000. PMID: 11032082 No abstract available.

3

Measures of exposure versus measures of rate and extent of absorption.

Chen ML, Lesko L, Williams RL. Chen ML, et al. Clin Pharmacokinet. 2001;40(8):565-72. doi: 10.2165/00003088-200140080-00001. Clin Pharmacokinet. 2001. PMID: 11523723 Review.

4

Bioavailability and bioequivalence: an FDA regulatory overview.

Chen ML, Shah V, Patnaik R, Adams W, Hussain A, Conner D, Mehta M, Malinowski H, Lazor J, Huang SM, Hare D, Lesko L, Sporn D, Williams R. Chen ML, et al. Pharm Res. 2001 Dec;18(12):1645-50. doi: 10.1023/a:1013319408893. Pharm Res. 2001. PMID: 11785681 Review.

5

Pharmacokinetic analysis of bioequivalence trials: implications for sex-related issues in clinical pharmacology and biopharmaceutics.

Chen ML, Lee SC, Ng MJ, Schuirmann DJ, Lesko LJ, Williams RL. Chen ML, et al. Among authors: lesko lj. Clin Pharmacol Ther. 2000 Nov;68(5):510-21. doi: 10.1067/mcp.2000.111184. Clin Pharmacol Ther. 2000. PMID: 11103754

6

Individual bioequivalence revisited.

Chen ML, Lesko LJ. Chen ML, et al. Among authors: lesko lj. Clin Pharmacokinet. 2001;40(10):701-6. doi: 10.2165/00003088-200140100-00001. Clin Pharmacokinet. 2001. PMID: 11707058 Review.

7

Bioequivalence assessment of generic drugs: an American point of view.

Patnaik R, Lesko LJ, Chan K, Williams RL. Patnaik R, et al. Among authors: lesko lj. Eur J Drug Metab Pharmacokinet. 1996 Apr-Jun;21(2):159-64. doi: 10.1007/BF03190265. Eur J Drug Metab Pharmacokinet. 1996. PMID: 8839690 Review. No abstract available.

8

Evaluation of bioequivalence of highly variable drugs using clinical trial simulations. II: Comparison of single and multiple-dose trials using AUC and Cmax.

el-Tahtawy AA, Tozer TN, Harrison F, Lesko L, Williams R. el-Tahtawy AA, et al. Pharm Res. 1998 Jan;15(1):98-104. doi: 10.1023/a:1011961006297. Pharm Res. 1998. PMID: 9487554

9

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. Sun H, et al. Clin Pharmacokinet. 1999 Jul;37(1):41-58. doi: 10.2165/00003088-199937010-00003. Clin Pharmacokinet. 1999. PMID: 10451782 Review.

10

Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling.

Singh GJ, Adams WP, Lesko LJ, Shah VP, Molzon JA, Williams RL, Pershing LK. Singh GJ, et al. Among authors: lesko lj. Clin Pharmacol Ther. 1999 Oct;66(4):346-57. doi: 10.1053/cp.1999.v66.a101209. Clin Pharmacol Ther. 1999. PMID: 10546918

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