Cite

1. G. Levy, What are narrow therapeutic index drugs? Clin. Pharmacol. Ther. 63 (1998) 501-505; https://doi.org/10.1016/S0009-9236(98)90100-X10.1016/S0009-9236(98)90100-XSearch in Google Scholar

2. L. X. Yu, Quality and bioequivalence standards for narrow therapeutic index drugs, GPhA 2011 Fall Technical Workshop, Bethesda, Maryland, USA, Oct 1-2, 2012; http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM292676.pdf; last access date March 19, 2017.Search in Google Scholar

3. US Food&Drug Administration, CFR - Code of Federal Regulations, Title 21 - Food and Drugs, Chapter I - Food and Drug Administration, Subchapter D - Drugs for Human Use, Part 320 - Bioavailability and Bioequivalence Requirements, Subpart B - Procedures for Determining the Bioavailability or Bioequivalence of Drug Products, Sec. 320.33 - Criteria and Evidence to Assess Actual or Potential Problems, Department of Health and Human Services, Silver Spring (MD) 2017, Vol. 5; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.33; last acces date March 19, 2017.Search in Google Scholar

4. J. Tamargo, J. L. Heuzey and P. Mabo, Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide, Eur. J. Clin. Pharmacol. 71 (2015) 549-567; https://doi.org/10.1007/s00228-015-1832-010.1007/s00228-015-1832-0441268825870032Search in Google Scholar

5. G. M. Currie, J. M. Wheat and H. Kiat, Pharmacokinetic considerations for digoxin in older people, Open Cardiovasc. Med. J. 5 (2011) 130-135; https://doi.org/10.2174/187419240110501013010.2174/1874192401105010130313494621769303Search in Google Scholar

6. A. Yacobi, E. Masson, D. Moros, D. Ganes, C. Lapointe, Z. Abolfathi, M. LeBel, Y. Golander, D. Doepner, T. Blumberg, Y. Cohen and B. Levitt, Who needs individual bioequivalence studies for narrow therapeutic index drugs? A case for warfarin, J. Clin. Pharmacol. 40 (2000) 826-835; https://doi.org/10.1177/0091270002200955810.1177/0091270002200955810934666Search in Google Scholar

7. M. Bialer, R. H. Levy and E. Perucca, Does carbamazepine have a narrow therapeutic plasma concentration range? Ther. Drug Monit. 20 (1998) 56-59; https://doi.org/10.1097/00007691-199802000-0001010.1097/00007691-199802000-000109485555Search in Google Scholar

8. J. Pesce, M. Rashkin and U. Kotagal, Standards of laboratory practice: theophylline and caffeine monitoring, Clin. Chem. 44 (1998) 1124-1128.Search in Google Scholar

9. J. W. Shin, K. Chu, K. H. Jung, S. T. Lee, J. Moon and S. K. Lee, Switching between phenytoin generics in patients with epilepsy may lead to increased risk of breakthrough seizure: chart analysis and practice recommendations, Int. J. Clin. Pharmacol. Ther. 52 (2014) 1017-1022; https://doi.org/10.5414/CP20215310.5414/CP20215325295717Search in Google Scholar

10. M. S. Paveliu, S. Bengea and F. S. Paveliu, Generic substitution issues: brand-generic substitution, generic-generic substitution, and generic substitution of narrow therapeutic index (NTI)/critical dose drugs, Maedica (Bucharest) 6 (2011) 52-58.Search in Google Scholar

11. Commonwealth of Pennsylvania, Generic Drug Equivalency/Substitution Laws and Regulations, Philadelphia (PA) April 1, 2017; https://apps.health.pa.gov/pdf/ddc/generic34.pdf; last access date June 21, 2017.Search in Google Scholar

12. W. C. Tom and K. Dotson, State regulations on generic substitution, Pharm. Lett. 22 (2006) Document# 220901.Search in Google Scholar

13. M. L. Chen, V. P. Shah, D. J. Crommelin, L. Shargel, D. Bashaw, M. Bhatti, H. Blume, J. Dressman, M. Ducharme, P. Fackler, T. Hyslop, L. Lutter, J. Morais, E. Ormsby, S. Thomas, Y. C. Tsang, R. Velagapudi and L. X. Yu, Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report, AAPS J. 13 (2011) 556-564; https://doi.org/10.1208/s12248-011-9294-510.1208/s12248-011-9294-5323185521845486Search in Google Scholar

14. FDA@Drugs, Coumadin Label (2016); http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf; last access date March 19, 2017.Search in Google Scholar

15. A. R. Sheth, W. W. Brennessel, V. G. Young, F. X. Muller and D. J. Grant, Solid-state properties of warfarin sodium 2-propanol solvate, J. Pharm. Sci. 93 (2004) 2669-2680; https://doi.org/10.1002/jps.2016410.1002/jps.2016415389677Search in Google Scholar

16. United States Pharmacopeia 39 - National Formulary 34, USP Convention, Rockville (MD) 2016.Search in Google Scholar

17. Z. Rahman, M. Korang-Yeboah, A. Siddiqui, A. Mohammad and M. A. Khan, Understanding effect of formulation and manufacturing variables on the critical quality attributes of warfarin sodium product, Int. J. Pharm. 495 (2015) 19-30; https://doi.org/10.1016/j.ijpharm.2015.08.06510.1016/j.ijpharm.2015.08.06526319638Search in Google Scholar

18. A. Nguyenpho, A. B. Ciavarella, A. Siddiqui, Z. Rahman, S. Akhtar, R. Hunt, M. Korang-Yeboah and M. A. Khan, Evaluation of in-use stability of anticoagulant drug products: warfarin sodium, J. Pharm. Sci. 104 (2015) 4232-4240; https://doi.org/10.1002/jps.2465710.1002/jps.2465726501849Search in Google Scholar

19. M. Korang-Yeboah, S. Akhtar, A. Siddiqui, Z. Rahman and M. A. Khan, Application of NIR chemometric methods for quantification of the crystalline fraction of warfarin sodium in drug products, Drug Dev. Ind. Pharm. 13 (2015) 1-11; https://doi.org/10.3109/03639045.2015.105881710.3109/03639045.2015.1058817Search in Google Scholar

20. A. Siddiqui, Z. Rahman, M. Korang-Yeboah and M. A. Khan, Development and validation of X-ray diffraction method for quantitative determination of crystallinity in warfarin sodium products, Int. J. Pharm. 493 (2015) 1-6; https://doi.org/10.1016/j.ijpharm.2015.07.05110.1016/j.ijpharm.2015.07.051Search in Google Scholar

21. Z. Rahman, A. A. Mohammad, S. Akhtar, A. Siddiqui, M. Korang-Yeboah and M. A. Khan, Chemometric model development and comparison of Raman and (13)C solid-state nuclear magnetic resonance-chemometric methods for quantification of crystalline/amorphous warfarin sodium fraction in the formulations, J. Pharm. Sci. 104 (2015) 2550-2558; https://doi.org/10.1002/jps.2452410.1002/jps.24524Search in Google Scholar

22. C. F. Poole and S. K. Poole, Chromatography Today, Elsevier Science, Amsterdam 1991, pp. 133.Search in Google Scholar

23. C. A. Cramers, J. A. Rijiks and P. Bocek, Packed versus capillary columns in gas chromatography, Clin. Chim. Acta 34 (1971) 159-167; https://doi.org/10.1016/0009-8981(71)90169-010.1016/0009-8981(71)90169-0Search in Google Scholar

24. E. Sarban, S. Socaci, M. Tofana, M. Simona and M. Bojita, Advantages of „headspace” technique for GC/MS analysis of essential oils, Farmacia 60 (2012) 249-256.Search in Google Scholar

25. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1), Current Step 4 version, ICH, Geneva, November 2005; https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf; last access March 19, 2017.Search in Google Scholar

26. A. Gupta, A. B. Ciavarella, V. A. Sayeed, M. A. Khan and P. J. Faustino, Development and application of validated HPLC method for the analysis of dissolution samples of gabapentin drug products, J. Pharm. Biomed. Anal. 46 (2008) 181-186; https://doi.org/org/10.1016/j.jpba.2007.08.02310.1016/j.jpba.2007.08.02317935923Search in Google Scholar

27. D. Awotwe-Otoo, C. Agarabi, P. J. Faustino, M. J. Habib, S. Lee, M. A. Khan, and R. B. Shah, Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate, J. Pharm. Biomed. Anal. 62 (2012) 61-67; https://doi.org/10.1016/j.jpba.2012.01.00210.1016/j.jpba.2012.01.00222316620Search in Google Scholar

28. FDA, CDER, Reviewer Guidance - Validation of Chromatographic Methods, Rockville (MD) 1994; https://www.fda.gov/downloads/Drugs/Guidances/UCM134409.pdf; last access date March 19, 2017.Search in Google Scholar

eISSN:
1846-9558
Language:
English
Publication timeframe:
4 times per year
Journal Subjects:
Pharmacy, other