Williams RL - 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: williams rl. Clin Pharmacokinet. 1997 Jul;33(1):1-6. doi: 10.2165/00003088-199733010-00001. Clin Pharmacokinet. 1997. PMID: 9250419 No abstract available.

2

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.

3

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.

4

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

Williams RL, Patnaik RN, Chen ML. Williams RL, et al. 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.

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

6

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

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

Equivalence approaches.

Williams RL, Chen ML, Hauck WW. Williams RL, et al. Clin Pharmacol Ther. 2002 Sep;72(3):229-37. doi: 10.1067/mcp.2002.126705. Clin Pharmacol Ther. 2002. PMID: 12235443 Review. No abstract available.

9

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. Int J Clin Pharmacol Ther. 1996 Dec;34(12):535-41. Int J Clin Pharmacol Ther. 1996. PMID: 8996848

10

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

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