Chen ML - Search Results

1

Novel bioequivalence approach for narrow therapeutic index drugs.

Yu LX, Jiang W, Zhang X, Lionberger R, Makhlouf F, Schuirmann DJ, Muldowney L, Chen ML, Davit B, Conner D, Woodcock J. Yu LX, et al. Among authors: chen ml. Clin Pharmacol Ther. 2015 Mar;97(3):286-91. doi: 10.1002/cpt.28. Epub 2014 Dec 15. Clin Pharmacol Ther. 2015. PMID: 25669762

2

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. Clin Pharmacol Ther. 2000 Nov;68(5):510-21. doi: 10.1067/mcp.2000.111184. Clin Pharmacol Ther. 2000. PMID: 11103754

3

Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence. FDA Individual Bioequivalence Working Group.

Hauck WW, Chen ML, Hyslop T, Patnaik R, Schuirmann D, Williams R. Hauck WW, et al. Among authors: chen ml. Int J Clin Pharmacol Ther. 1996 Dec;34(12):535-41. Int J Clin Pharmacol Ther. 1996. PMID: 8996848

4

An individual bioequivalence criterion: regulatory considerations.

Chen ML, Patnaik R, Hauck WW, Schuirmann DJ, Hyslop T, Williams R. Chen ML, et al. Stat Med. 2000 Oct 30;19(20):2821-42. doi: 10.1002/1097-0258(20001030)19:20<2821::aid-sim548>3.0.co;2-l. Stat Med. 2000. PMID: 11033578

5

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.

6

Individual bioequivalence revisited.

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

7

Limits of 80%-125% for AUC and 70%-143% for Cmax. What is the impact on bioequivalence studies?

Hauck WW, Parekh A, Lesko LJ, Chen ML, Williams RL. Hauck WW, et al. Among authors: chen ml. Int J Clin Pharmacol Ther. 2001 Aug;39(8):350-5. doi: 10.5414/cpp39350. Int J Clin Pharmacol Ther. 2001. PMID: 11515710

8

The basis for individual bioequivalence. FDA Population and Individual Bioequivalence Working Group.

Williams RL, Patnaik RN, Chen ML. Williams RL, et al. Among authors: chen ml. Eur J Drug Metab Pharmacokinet. 2000 Jan-Mar;25(1):13-7. doi: 10.1007/BF03190050. Eur J Drug Metab Pharmacokinet. 2000. PMID: 11032083 No abstract available.

9

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.

10

Individual bioequivalence--a regulatory update.

Chen ML. Chen ML. J Biopharm Stat. 1997 Mar;7(1):5-11. doi: 10.1080/10543409708835162. J Biopharm Stat. 1997. PMID: 9056581 Review. No abstract available.

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