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Items: 16

1.

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride.

Plöger GF, Abrahamsson B, Cristofoletti R, Groot DW, Langguth P, Mehta MU, Parr A, Polli JE, Shah VP, Tajiri T, Dressman JB.

J Pharm Sci. 2018 Jul;107(7):1761-1772. doi: 10.1016/j.xphs.2018.03.009. Epub 2018 Mar 20. Review.

PMID:
29571740
2.

Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.

Mehta MU, Uppoor RS, Conner DP, Seo P, Vaidyanathan J, Volpe DA, Stier E, Chilukuri D, Dorantes A, Ghosh T, Mandula H, Raines K, Dhanormchitphong P, Woodcock J, Yu LX.

Mol Pharm. 2017 Dec 4;14(12):4334-4338. doi: 10.1021/acs.molpharmaceut.7b00687. Epub 2017 Nov 7.

PMID:
29076742
3.

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.

Hofsäss MA, Souza J, Silva-Barcellos NM, Bellavinha KR, Abrahamsson B, Cristofoletti R, Groot DW, Parr A, Langguth P, Polli JE, Shah VP, Tajiri T, Mehta MU, Dressman JB.

J Pharm Sci. 2017 Dec;106(12):3421-3430. doi: 10.1016/j.xphs.2017.08.007. Epub 2017 Aug 24.

PMID:
28842299
4.

Exposure-response analyses of blood pressure and heart rate changes for methylphenidate in healthy adults.

Li L, Wang Y, Uppoor RS, Mehta MU, Farchione T, Mathis MV, Zhu H.

J Pharmacokinet Pharmacodyn. 2017 Jun;44(3):245-262. doi: 10.1007/s10928-017-9513-5. Epub 2017 Feb 18.

PMID:
28214989
5.

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin.

Goodarzi N, Barazesh Morgani A, Abrahamsson B, Cristofoletti R, Groot DW, Langguth P, Mehta MU, Polli JE, Shah VP, Dressman JB.

J Pharm Sci. 2016 Apr;105(4):1362-9. doi: 10.1016/j.xphs.2016.01.017. Epub 2016 Mar 5.

PMID:
26952879
6.

An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: review of recent cases in psychiatry drugs.

Younis IR, Rogers H, Zhang H, Zhu H, Uppoor RS, Mehta MU.

J Clin Pharmacol. 2013 Oct;53(10):1005-9. doi: 10.1002/jcph.118. Epub 2013 Jul 10. Review.

PMID:
23842865
7.

Statistics on BCS classification of generic drug products approved between 2000 and 2011 in the USA.

Nair AK, Anand O, Chun N, Conner DP, Mehta MU, Nhu DT, Polli JE, Yu LX, Davit BM.

AAPS J. 2012 Dec;14(4):664-6. doi: 10.1208/s12248-012-9384-z. Epub 2012 Jun 21.

8.

The use of imaging in the early development of neuropharmacological drugs: a survey of approved NDAs.

Uppoor RS, Mummaneni P, Cooper E, Pien HH, Sorensen AG, Collins J, Mehta MU, Yasuda SU.

Clin Pharmacol Ther. 2008 Jul;84(1):69-74. doi: 10.1038/sj.clpt.6100422. Epub 2007 Nov 21.

PMID:
18563070
9.

Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.

Bhattaram VA, Booth BP, Ramchandani RP, Beasley BN, Wang Y, Tandon V, Duan JZ, Baweja RK, Marroum PJ, Uppoor RS, Rahman NA, Sahajwalla CG, Powell JR, Mehta MU, Gobburu JV.

AAPS J. 2005 Oct 7;7(3):E503-12. Review.

10.

The effect of food on the relative bioavailability of rapidly dissolving immediate-release solid oral products containing highly soluble drugs.

Yu LX, Straughn AB, Faustino PJ, Yang Y, Parekh A, Ciavarella AB, Asafu-Adjaye E, Mehta MU, Conner DP, Lesko LJ, Hussain AS.

Mol Pharm. 2004 Sep-Oct;1(5):357-62.

PMID:
16026005
11.

Biopharmaceutics classification system: the scientific basis for biowaiver extensions.

Yu LX, Amidon GL, Polli JE, Zhao H, Mehta MU, Conner DP, Shah VP, Lesko LJ, Chen ML, Lee VH, Hussain AS.

Pharm Res. 2002 Jul;19(7):921-5.

12.

Approaches to the development and marketing approval of drugs that prevent cancer.

Kelloff GJ, Johnson JR, Crowell JA, Boone CW, DeGeorge JJ, Steele VE, Mehta MU, Temeck JW, Schmidt WJ, Burke G, et al.

Cancer Epidemiol Biomarkers Prev. 1995 Jan-Feb;4(1):1-10. Review.

13.

Guidance for development of chemopreventive agents.

Kelloff GJ, Johnson JR, Crowell JA, Boone CW, DeGeorge JJ, Steele VE, Mehta MU, Temeck JW, Schmidt WJ, Burke G, et al.

J Cell Biochem Suppl. 1994;20:25-31. No abstract available.

PMID:
7616748
14.

Pharmacokinetic evaluation of drug interactions with anti-HIV drugs, II: Effect of 2',3'-dideoxyinosine (ddI) on zidovudine kinetics in monkeys.

Gallo JM, Finco TS, Swagler AR, Mehta MU, Viswanathan CT, Qian M.

AIDS Res Hum Retroviruses. 1992 Feb;8(2):277-83.

PMID:
1540413
15.

Effect of bile on cyclosporin absorption in liver transplant patients.

Mehta MU, Venkataramanan R, Burckart GJ, Ptachcinski RJ, Delamos B, Stachak S, Van Thiel DH, Iwatsuki S, Starzl TE.

Br J Clin Pharmacol. 1988 May;25(5):579-84.

16.

Antipyrine kinetics in liver disease and liver transplantation.

Mehta MU, Venkataramanan R, Burckart GJ, Ptachcinski RJ, Yang SL, Gray JA, Van Thiel DH, Starzl TE.

Clin Pharmacol Ther. 1986 Apr;39(4):372-7.

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