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Items: 1 to 20 of 100

1.

Statistical considerations and impact of the FDA draft guidance for assessing adhesion with transdermal delivery systems and topical patches for ANDAs.

Sun W, Grosser S, Kim C, Raney SG.

J Biopharm Stat. 2019;29(5):952-970. doi: 10.1080/10543406.2019.1657440. Epub 2019 Sep 8.

PMID:
31495266
2.

Pharmaceutical impurities: regulatory perspective for Abbreviated New Drug Applications.

Basak AK, Raw AS, Al Hakim AH, Furness S, Samaan NI, Gill DS, Patel HB, Powers RF, Yu L.

Adv Drug Deliv Rev. 2007 Jan 10;59(1):64-72. Epub 2006 Nov 15. Review.

PMID:
17196703
3.

Ratio of means vs. difference of means as measures of superiority, noninferiority, and average bioequivalence.

Sun W, Grosser S, Tsong Y.

J Biopharm Stat. 2017;27(2):338-355. doi: 10.1080/10543406.2016.1265536. Epub 2016 Dec 6.

PMID:
27922340
4.

Validation of a fentanyl transdermal adhesion scoring tool for use in clinical practice.

Bista SR, Hardy J, Tapuni A, Fu J, Gibbons K, Good P, Norris R, Haywood A.

J Pain Symptom Manage. 2015 May;49(5):934-8. doi: 10.1016/j.jpainsymman.2014.09.017. Epub 2014 Dec 15.

PMID:
25523888
5.

Sumatriptan transdermal system can be correctly assembled and applied during migraine attacks.

Meadows KP, Pierce M, O'Neill C, Foster S, Jennings C.

Headache. 2014 May;54(5):850-60. doi: 10.1111/head.12352. Epub 2014 Apr 7.

PMID:
24708392
6.

Percutaneous penetration of drugs applied in transdermal delivery systems: an in vivo based approach for evaluating computer generated penetration models.

Keurentjes AJ, Maibach HI.

Regul Toxicol Pharmacol. 2019 Nov;108:104428. doi: 10.1016/j.yrtph.2019.104428. Epub 2019 Jul 18.

PMID:
31326435
7.

On the Road to Development of an in Vitro Permeation Test (IVPT) Model to Compare Heat Effects on Transdermal Delivery Systems: Exploratory Studies with Nicotine and Fentanyl.

Shin SH, Ghosh P, Newman B, Hammell DC, Raney SG, Hassan HE, Stinchcomb AL.

Pharm Res. 2017 Sep;34(9):1817-1830. doi: 10.1007/s11095-017-2189-0. Epub 2017 Jun 12.

PMID:
28608140
8.

A new transdermal delivery system for pilocarpine in glaucoma treatment.

Dinslage S, Diestelhorst M, Hille T, Otto K.

Ger J Ophthalmol. 1996 Sep;5(5):275-80.

PMID:
8911949
9.

Pharmacokinetics of a new testosterone transdermal delivery system, TDS-testosterone in healthy males.

Chik Z, Johnston A, Tucker AT, Chew SL, Michaels L, Alam CA.

Br J Clin Pharmacol. 2006 Mar;61(3):275-9.

10.
11.

Population and individual bioequivalence: lessons from real data and simulation studies.

Zariffa NM, Patterson SD.

J Clin Pharmacol. 2001 Aug;41(8):811-22.

PMID:
11504268
12.

Assessing the ratio of means as a causal estimand in clinical endpoint bioequivalence studies in the presence of intercurrent events.

Lou Y, Jones MP, Sun W.

Stat Med. 2019 Oct 17. doi: 10.1002/sim.8367. [Epub ahead of print]

PMID:
31621943
14.

Pharmacokinetics of formulated tenoxicam transdermal delivery systems.

Kim T, Kang E, Chun I, Gwak H.

J Pharm Pharmacol. 2008 Jan;60(1):135-8.

PMID:
18088513
15.
16.

More about the basic assumptions of t-test: normality and sample size.

Kim TK, Park JH.

Korean J Anesthesiol. 2019 Aug;72(4):331-335. doi: 10.4097/kja.d.18.00292. Epub 2019 Apr 1.

17.

A more powerful test based on ratio distribution for retention noninferiority hypothesis.

Deng L, Chen G.

J Biopharm Stat. 2013 Mar 11;23(2):346-60. doi: 10.1080/10543406.2011.616968.

PMID:
23437943
18.

Review of Acute Treatment of Migraine Trial Results With the New FDA Endpoints: Design Implications for Future Trials.

Hindiyeh NA, Kellerman DJ, Schmidt PC.

Headache. 2019 May;59(5):819-824. doi: 10.1111/head.13511. Epub 2019 Apr 6. Erratum in: Headache. 2019 Sep;59(8):1427.

19.

Pharmacokinetics of continuous once-a-week combination 17β-Estradiol/Low- or high-dose levonorgestrel transdermal delivery systems in postmenopausal women.

Karara AH, Harrison LI, Melikian AP, Poola N, Morrison D, Bourg D, Bourg L, Zurth C.

J Clin Pharmacol. 2014 May;54(5):520-7. doi: 10.1002/jcph.238. Epub 2014 Jan 29.

PMID:
24474034
20.

In-vitro release and transdermal fluxes of a highly lipophilic drug and of enhancers from matrix TDS.

Funke AP, Günther C, Müller RH, Lipp R.

J Control Release. 2002 Jul 18;82(1):63-70.

PMID:
12106977

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