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Items: 1 to 20 of 873

1.

Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.

Hussaarts L, Mühlebach S, Shah VP, McNeil S, Borchard G, Flühmann B, Weinstein V, Neervannan S, Griffiths E, Jiang W, Wolff-Holz E, Crommelin DJA, de Vlieger JSB.

Ann N Y Acad Sci. 2017 Apr 26. doi: 10.1111/nyas.13347. [Epub ahead of print]

PMID:
28445611
2.

Two decades of glatiramer acetate: From initial discovery to the current development of generics.

Weinstock-Guttman B, Nair KV, Glajch JL, Ganguly TC, Kantor D.

J Neurol Sci. 2017 May 15;376:255-259. doi: 10.1016/j.jns.2017.03.030. Epub 2017 Mar 21. Review.

3.

Provider and Patient Determinants of Generic Levothyroxine Prescribing: An Electronic Health Records-Based Study.

Romanelli RJ, Nimbal V, Dutcher SK, Pu X, Segal JB.

Ann Pharmacother. 2017 Apr 1:1060028017705393. doi: 10.1177/1060028017705393. [Epub ahead of print]

PMID:
28425295
4.

In Vitro Evaluation of Nasogastric Tube Delivery Performance of Esomeprazole Magnesium Delayed-Release Capsules.

Hoover A, Sun D, Wen H, Jiang W, Cui M, Jiang X, Keire D, Guo C.

J Pharm Sci. 2017 Apr 15. pii: S0022-3549(17)30240-X. doi: 10.1016/j.xphs.2017.04.008. [Epub ahead of print]

PMID:
28416417
5.

Ensuring Access to Injectable Generic Drugs - The Case of Intravesical BCG for Bladder Cancer.

Davies BJ, Hwang TJ, Kesselheim AS.

N Engl J Med. 2017 Apr 13;376(15):1401-1403. doi: 10.1056/NEJMp1615697. No abstract available.

PMID:
28402764
6.

Drug shortages in Israel: regulatory perspectives, challenges and solutions.

Schwartzberg E, Ainbinder D, Vishkauzan A, Gamzu R.

Isr J Health Policy Res. 2017 Apr 3;6:17. doi: 10.1186/s13584-017-0140-9. eCollection 2017.

7.

Development of in vitro-in vivo correlation of parenteral naltrexone loaded polymeric microspheres.

Andhariya JV, Shen J, Choi S, Wang Y, Zou Y, Burgess DJ.

J Control Release. 2017 Apr 4;255:27-35. doi: 10.1016/j.jconrel.2017.03.396. [Epub ahead of print]

PMID:
28385676
8.

Do patients trust the FDA?: a survey assessing how patients view the generic drug approval process.

Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Campbell EG.

Pharmacoepidemiol Drug Saf. 2017 Mar 31. doi: 10.1002/pds.4205. [Epub ahead of print]

PMID:
28370652
9.

Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature.

Beijers L, Jeronimus BF, Turner EH, de Jonge P, Roest AM.

BMJ Open. 2017 Mar 29;7(3):e012886. doi: 10.1136/bmjopen-2016-012886.

10.

Physiologically Based Pharmacokinetic and Absorption Modeling for Osmotic Pump Products.

Ni Z, Talattof A, Fan J, Tsakalozou E, Sharan S, Sun D, Wen H, Zhao L, Zhang X.

AAPS J. 2017 Mar 29. doi: 10.1208/s12248-017-0075-7. [Epub ahead of print]

PMID:
28357656
11.

Mechanisms of in vivo release of triamcinolone acetonide from PLGA microspheres.

Doty AC, Weinstein DG, Hirota K, Olsen KF, Ackermann R, Wang Y, Choi S, Schwendeman SP.

J Control Release. 2017 Mar 22;256:19-25. doi: 10.1016/j.jconrel.2017.03.031. [Epub ahead of print]

PMID:
28342981
12.

Pharmaceuticals and Medical Devices: FDA Oversight.

White RS; Thomson Reuters Accelus..

Issue Brief Health Policy Track Serv. 2016 Dec 27;2016:1-74. No abstract available.

PMID:
28252887
13.

Pharmaceuticals and Medical Devices: Cost Savings.

Steiner DJ; Thomson Reuters Accelus..

Issue Brief Health Policy Track Serv. 2016 Dec 27;2016:1-31. No abstract available.

PMID:
28252884
14.

A Citizen's Pathway Gone Astray - Delaying Competition from Generic Drugs.

Feldman R, Wang C.

N Engl J Med. 2017 Apr 20;376(16):1499-1501. doi: 10.1056/NEJMp1700202. Epub 2017 Mar 1. No abstract available.

PMID:
28248550
15.

Demonstration of Biological and Immunological Equivalence of a Generic Glatiramer Acetate.

D Alessandro JD, Garofalo K, Zhao G, Honan C, Duffner J, Capila I, Fier I, Kaundinya G, Kantor D, Ganguly T.

CNS Neurol Disord Drug Targets. 2017 Feb 23. doi: 10.2174/1871527316666170223162747. [Epub ahead of print]

PMID:
28240190
16.

In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context.

Lennernäs H, Lindahl A, Van Peer A, Ollier C, Flanagan T, Lionberger R, Nordmark A, Yamashita S, Yu L, Amidon GL, Fischer V, Sjögren E, Zane P, McAllister M, Abrahamsson B.

Mol Pharm. 2017 Apr 3;14(4):1307-1314. doi: 10.1021/acs.molpharmaceut.6b00824. Epub 2017 Mar 1.

PMID:
28195732
17.

Extrapolation and Interchangeability of Infliximab and Adalimumab in Inflammatory Bowel Disease.

Chang S, Hanauer S.

Curr Treat Options Gastroenterol. 2017 Mar;15(1):53-70. doi: 10.1007/s11938-017-0122-6. Review.

PMID:
28164249
18.

Performance of Redox Active and Chelatable Iron Assays to Determine Labile Iron Release From Intravenous Iron Formulations.

Pai AB, Meyer DE, Bales BC, Cotero VE, Pai MP, Zheng N, Jiang W.

Clin Transl Sci. 2017 May;10(3):194-200. doi: 10.1111/cts.12443. Epub 2017 Feb 3.

PMID:
28160427
19.

Accelerated in vitro release testing method for naltrexone loaded PLGA microspheres.

Andhariya JV, Choi S, Wang Y, Zou Y, Burgess DJ, Shen J.

Int J Pharm. 2017 Mar 30;520(1-2):79-85. doi: 10.1016/j.ijpharm.2017.01.050. Epub 2017 Jan 30.

PMID:
28153651
20.

Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials.

Zheng N, Sun DD, Zou P, Jiang W.

AAPS J. 2017 May;19(3):619-631. doi: 10.1208/s12248-017-0044-1. Epub 2017 Jan 23.

PMID:
28116676

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