Similar articles for PMID: 30414386

Year	Number of Results
1993	5
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2001	3
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2021	25
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2024	0

1

Generating Model Integrated Evidence for Generic Drug Development and Assessment.

Zhao L, Kim MJ, Zhang L, Lionberger R. Zhao L, et al. Clin Pharmacol Ther. 2019 Feb;105(2):338-349. doi: 10.1002/cpt.1282. Epub 2019 Jan 20. Clin Pharmacol Ther. 2019. PMID: 30414386

2

Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop.

Fang L, Kim MJ, Li Z, Wang Y, DiLiberti CE, Au J, Hooker A, Ducharme MP, Lionberger R, Zhao L. Fang L, et al. Clin Pharmacol Ther. 2018 Jul;104(1):27-30. doi: 10.1002/cpt.1065. Epub 2018 Mar 30. Clin Pharmacol Ther. 2018. PMID: 29603191

3

United States Food and Drug Administration requirements for approval of generic drug products.

Meyer MC. Meyer MC. J Clin Psychiatry. 2001;62 Suppl 5:4-9; discussion 23-4. J Clin Psychiatry. 2001. PMID: 11305846 Review.

4

Dissolution testing for generic drugs: an FDA perspective.

Anand O, Yu LX, Conner DP, Davit BM. Anand O, et al. AAPS J. 2011 Sep;13(3):328-35. doi: 10.1208/s12248-011-9272-y. Epub 2011 Apr 9. AAPS J. 2011. PMID: 21479700 Free PMC article.

5

Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.

Kesselheim AS, Polinski JM, Fulchino LA, Isaman DL, Gagne JJ. Kesselheim AS, et al. Drugs. 2015 Apr;75(6):633-50. doi: 10.1007/s40265-015-0382-1. Drugs. 2015. PMID: 25822610 Review.

6

Applications of In Vitro-In Vivo Correlations in Generic Drug Development: Case Studies.

Kaur P, Jiang X, Duan J, Stier E. Kaur P, et al. AAPS J. 2015 Jul;17(4):1035-9. doi: 10.1208/s12248-015-9765-1. Epub 2015 Apr 22. AAPS J. 2015. PMID: 25896303 Free PMC article.

7

Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union.

Kuribayashi R, Yamaguchi T, Sako H, Takishita T, Takagi K. Kuribayashi R, et al. Clin Pharmacokinet. 2017 Mar;56(3):225-233. doi: 10.1007/s40262-016-0438-8. Clin Pharmacokinet. 2017. PMID: 27461251 Review.

8

Lawsuits anticipated on generic biologicals front.

Fox JL. Fox JL. Nat Biotechnol. 2003 Jul;21(7):721-2. doi: 10.1038/nbt0703-721. Nat Biotechnol. 2003. PMID: 12833078 No abstract available.

9

Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan.

Kuribayashi R, Takishita T, Mikami K. Kuribayashi R, et al. J Pharm Sci. 2016 Aug;105(8):2270-7. doi: 10.1016/j.xphs.2016.05.026. Epub 2016 Jun 30. J Pharm Sci. 2016. PMID: 27372551

10

In U.S., biosimilars still await FDA decision.

Finkelstein JB. Finkelstein JB. J Natl Cancer Inst. 2006 Apr 5;98(7):435. doi: 10.1093/jnci/djj146. J Natl Cancer Inst. 2006. PMID: 16595775 No abstract available.

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