A review of consideration of ethnic factors during drug approval process
Corresponding Author(s) : SudershanGoud Gokari
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 6 No. 1 (2018): 2018 Volume 6- Issue -1
Abstract
Purpose
To determine feasibility of drug registration for the selected drugs at USFDA based on the ICH E5 guideline.
Methods
Methodology involves two steps, they are 1. Determination of ethnic sensitivity of the selected drugs based on factors such as pharmacokinetics (PK), pharmacodynamic (PD), therapeutic range, and metabolism etc., given in appendix D of ICH E5 guidelines. 2. Determination of the need for the bridging studies after determining ethnic sensitivity of the selected drugs based on the ICH E5 guidelines.
Results
After the extensive analysis of the selected drugs, ethnic factors found to have profound effect across all classes of drugs like Analgesics and Anti-Inflammatory Agents, Central Nervous System Agents, Antihypertensive Drugs, Anticoagulants, Metabolism and Endocrine Agents, Immunomodulators, Anticancer Agents, Gastrointestinal Agents, Antiparasitic Agents and Genitourinary Agents.
Conclusion
Some drugs may be ethnically insensitive and some other drugs may be ethnically sensitive among the selected drugs based on the ICH E5 guideline.
Drugs which are ethnically insensitive may be approved by USFDA (United States Food and Drug Administration) without need of bridging studies where as drugs which are ethnically sensitive and they need bridging studies before they can be approved.
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Di Masi JA HR, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 22(2), 2003, 151-85.
[2]. ICH E5 (R1): Ethnic Factors in the Acceptability of Foreign Clinical Data, 1998.
[3]. Betahistine, Nicorandil, Celiprolol, Sulpiride and Tenoxicam [database on the Internet]. IMS Health Incorporated. 9, 2011.
[4]. Chapter 1 Role of bioanalysis in pharmaceutical drug development. In: David AW, editor. Progress in Pharmaceutical and Biomedical Analysis: Elsevier; 2003, 1-10.
[5]. Bjornsson TD WJ, Donahue SR, Harper D, Karim A, Khouri MS, Murphy WR, Roman K, Schneck D, Sonnichsen DS, Stalker DJ, Wise SD, Dombey S, Loew C. A review and assessment of potential sources of ethnic differences in drug responsiveness. J Clin Pharmacol. 43(9), 2003, 943-67.
[6]. Burroughs VJ MR, Levy RA. Racial and ethnic differences in response to medicines: towards individualized pharmaceutical treatment. J Natl Med Assoc. 94(10), 2002, 1-26.
[7]. Yasuda SU ZL, Huang SM. The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies. Clin Pharmacol Ther. 84(3), 2008, 417-23.
[8]. Arbiser JL KS, van Leeuwen R, Hurwitz SJ, Selig M, Dickersin GR, Flint A, Byers HR, Chen LB. Clioquinol-zinc chelate: a candidate causative agent of subacute myelo-optic neuropathy. Mol Med. 4(10), 1998, 665-70.
[9]. Correia MA. Drug Biotransformation. In: G.Katzung B, editor. Basic & Clinical Pharmacology. 11 ed. New Delhi: Tata Mc Graw Hill Education Private Limited; 2009, 65.
[10]. Molzon JA, Giaquinto A, Lindstrom L, Tominaga T, Ward M, Doerr P, et al. The Value and Benefits of the International Conference on Harmonisation to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health. Clin Pharmacol Ther. 89(4), 2011, 503-12.
[11]. Goto M, Hamasaki T. Practical issues and observations on the use of foreign clinical data in drug development. Journal of biopharmaceutical statistics 12(3), 2002, 369-84.
[12]. Huang SM, Temple R. Is This the Drug or Dose for You? Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice. Clin Pharmacol Ther. 84(3), 2008, 287-94.
[13]. Algorithm for Evaluation of Bridging Studies in Taiwan. Available from: URL: http://www.cde.org.tw/Data/CDEDoc/Documents/Algorithm%20for%20Evaluation%20of%20Bridging%20Studies%20in%20Taiwan.pdf, 2011.
[14]. Uyama Y, Shibata T, Nagai N, Hanaoka H, Toyoshima S, Mori K. Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan. Clin Pharmacol Ther. 2005; 78(2):102-13.
[15]. Chow J-pLS-C. Bridging Studies in Clinical Development. Journal of Biopharmaceutical Statistics. 12(3), 2002, 359s-67.
References
[2]. ICH E5 (R1): Ethnic Factors in the Acceptability of Foreign Clinical Data, 1998.
[3]. Betahistine, Nicorandil, Celiprolol, Sulpiride and Tenoxicam [database on the Internet]. IMS Health Incorporated. 9, 2011.
[4]. Chapter 1 Role of bioanalysis in pharmaceutical drug development. In: David AW, editor. Progress in Pharmaceutical and Biomedical Analysis: Elsevier; 2003, 1-10.
[5]. Bjornsson TD WJ, Donahue SR, Harper D, Karim A, Khouri MS, Murphy WR, Roman K, Schneck D, Sonnichsen DS, Stalker DJ, Wise SD, Dombey S, Loew C. A review and assessment of potential sources of ethnic differences in drug responsiveness. J Clin Pharmacol. 43(9), 2003, 943-67.
[6]. Burroughs VJ MR, Levy RA. Racial and ethnic differences in response to medicines: towards individualized pharmaceutical treatment. J Natl Med Assoc. 94(10), 2002, 1-26.
[7]. Yasuda SU ZL, Huang SM. The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies. Clin Pharmacol Ther. 84(3), 2008, 417-23.
[8]. Arbiser JL KS, van Leeuwen R, Hurwitz SJ, Selig M, Dickersin GR, Flint A, Byers HR, Chen LB. Clioquinol-zinc chelate: a candidate causative agent of subacute myelo-optic neuropathy. Mol Med. 4(10), 1998, 665-70.
[9]. Correia MA. Drug Biotransformation. In: G.Katzung B, editor. Basic & Clinical Pharmacology. 11 ed. New Delhi: Tata Mc Graw Hill Education Private Limited; 2009, 65.
[10]. Molzon JA, Giaquinto A, Lindstrom L, Tominaga T, Ward M, Doerr P, et al. The Value and Benefits of the International Conference on Harmonisation to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health. Clin Pharmacol Ther. 89(4), 2011, 503-12.
[11]. Goto M, Hamasaki T. Practical issues and observations on the use of foreign clinical data in drug development. Journal of biopharmaceutical statistics 12(3), 2002, 369-84.
[12]. Huang SM, Temple R. Is This the Drug or Dose for You? Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice. Clin Pharmacol Ther. 84(3), 2008, 287-94.
[13]. Algorithm for Evaluation of Bridging Studies in Taiwan. Available from: URL: http://www.cde.org.tw/Data/CDEDoc/Documents/Algorithm%20for%20Evaluation%20of%20Bridging%20Studies%20in%20Taiwan.pdf, 2011.
[14]. Uyama Y, Shibata T, Nagai N, Hanaoka H, Toyoshima S, Mori K. Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan. Clin Pharmacol Ther. 2005; 78(2):102-13.
[15]. Chow J-pLS-C. Bridging Studies in Clinical Development. Journal of Biopharmaceutical Statistics. 12(3), 2002, 359s-67.