Patnaik RN - Search Results

1

Bioanalytical method validation--a revisit with a decade of progress.

Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A. Shah VP, et al. Among authors: patnaik rn. Pharm Res. 2000 Dec;17(12):1551-7. doi: 10.1023/a:1007669411738. Pharm Res. 2000. PMID: 11303967 Clinical Trial. No abstract available.

2

Evaluation of orally administered highly variable drugs and drug formulations.

Shah VP, Yacobi A, Barr WH, Benet LZ, Breimer D, Dobrinska MR, Endrenyi L, Fairweather W, Gillespie W, Gonzalez MA, Hooper J, Jackson A, Lesko LJ, Midha KK, Noonan PK, Patnaik R, Williams RL. Shah VP, et al. Pharm Res. 1996 Nov;13(11):1590-4. doi: 10.1023/a:1016468018478. Pharm Res. 1996. PMID: 8956322 Review. No abstract available.

3

Conference report: Bio-International 2005.

Midha KK, Shah VP, Singh GJ, Patnaik R. Midha KK, et al. J Pharm Sci. 2007 Apr;96(4):747-54. doi: 10.1002/jps.20786. J Pharm Sci. 2007. PMID: 17094144

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

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.

6

Bioequivalence of methylphenidate immediate-release tablets using a replicated study design to characterize intrasubject variability.

Meyer MC, Straughn AB, Jarvi EJ, Patrick KS, Pelsor FR, Williams RL, Patnaik R, Chen ML, Shah VP. Meyer MC, et al. Pharm Res. 2000 Apr;17(4):381-4. doi: 10.1023/a:1007560500301. Pharm Res. 2000. PMID: 10870979 Clinical Trial.

7

Subject-by-formulation interaction in bioequivalence: conceptual and statistical issues. FDA Population/Individual Bioequivalence Working Group. Food and Drug Administration.

Hauck WW, Hyslop T, Chen ML, Patnaik R, Williams RL. Hauck WW, et al. Pharm Res. 2000 Apr;17(4):375-80. doi: 10.1023/a:1007508516231. Pharm Res. 2000. PMID: 10870978

8

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

9

Bioequivalence: performance of several measures of rate of absorption.

Bois FY, Tozer TN, Hauck WW, Chen ML, Patnaik R, Williams RL. Bois FY, et al. Pharm Res. 1994 Jul;11(7):966-74. doi: 10.1023/a:1018970901116. Pharm Res. 1994. PMID: 7937556

10

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

Patnaik R, Lesko LJ, Chan K, Williams RL. Patnaik R, et al. 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.

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