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Challenges with Clinical Endpoints—Bioequivalence

A Brief Walk Through the History of Topical Bioequivalence

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Topical Drug Bioavailability, Bioequivalence, and Penetration

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Abstract

Demonstration of bioequivalence can be helpful in a variety of situations, including regulatory assessment of generic drug formulations and determining equivalent drug dosing. Finding a universally standard method of measuring topical bioequivalence has eluded dermatology to date. This paper offers the reader selected examples of advances and creative insights into clinical endpoints and attempts at topical bioequivalence, giving a historical understanding of the current state of bioequivalence with a view towards the future.

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References

  1. Commissioner O of the Consumer Updates—Kefauver-Harris Amendments Revolutionized Drug Development. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm322856.htm. Accessed 16 Jan 2014.

  2. Commissioner O of the Overviews on FDA history—FDA and clinical drug trials: a short history. http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm304485.htm. Accessed 17 Feb 2014.

  3. Yacobi A, Shah VP, Bashaw ED, et al. Current challenges in bioequivalence, quality, and novel assessment technologies for topical products. Pharm Res. 2014. doi:10.1007/s11095-013-1259-1.

    Google Scholar 

  4. McKenzie AW. Percutaneous absorption of steroids. Arch Dermatol. 1962;86(5):611–14. doi:10.1001/archderm.1962.01590110047006.

    Article  Google Scholar 

  5. Cook CH, Centner RL, Michaels SE. An acne grading method using photographic standards. Arch Dermatol. 1979;115(5):571–5.

    Article  CAS  PubMed  Google Scholar 

  6. Chiang A, Hafeez F, Maibach HI. Skin lesion metrics: role of photography in acne. J Dermatol Treat. 2014;25(2):100–5. doi:10.3109/09546634.2013.813010.

    Article  Google Scholar 

  7. Price VH, Menefee E, Sanchez M, Ruane P, Kaufman KD. Changes in hair weight and hair count in men with androgenetic alopecia after treatment with finasteride, 1 mg, daily. J Am Acad Dermatol. 2002;46(4):517–23.

    Article  PubMed  Google Scholar 

  8. Olsen EA, Whiting DA, Savin R, et al. Global photographic assessment of men aged 18 to 60 years with male pattern hair loss receiving finasteride 1 mg or placebo. J Am Acad Dermatol. 2012;67(3):379–86. doi:10.1016/j.jaad.2011.10.027.

    Article  PubMed  Google Scholar 

  9. Sulzberger MB, Shaw HC, Kanof A. Evaluation of measures for use against common fungous infections of the skin: screening tests by means of paired comparisons on human subjects. US Nav M Bull. 1945;45:237–48.

    Google Scholar 

  10. Katz M, Shaikh Z, Maibac HI. Scholtz–Dumas psoriasis small plaque bioassay. J Dermatol Treat. 2000;11(1):15–9. doi:10.1080/095466300750163717.

    Google Scholar 

  11. Armitage P. Sequential medical trials. Wiley; 1975, 2nd edition, John Wiley & Sons Inc, New York City, NY.

    Google Scholar 

  12. Beecher HK. The powerful placebo. J Am Med Assoc. 1955;159(17):1602–6.

    Article  CAS  PubMed  Google Scholar 

  13. Strafella AP, Ko JH, Monchi O. Therapeutic application of transcranial magnetic stimulation in Parkinson’s disease: the contribution of expectation. Neuroimage. 2006;31(4):1666–72. doi:10.1016/j.neuroimage.2006.02.005.

    Article  PubMed Central  PubMed  Google Scholar 

  14. Chiou WL. Low intrinsic drug activity and dominant vehicle (placebo) effect in the topical treatment of acne vulgaris. Int J Clin Pharmacol Ther. 2012;50(6):434–37.

    Article  CAS  PubMed  Google Scholar 

  15. Lamel SA, Myer KA, Younes N, Zhou JA, Maibach H, Maibach HI. Placebo response in relation to clinical trial design: a systematic review and meta-analysis of randomized controlled trials for determining biologic efficacy in psoriasis treatment. Arch Dermatol Res. 2012;304(9):707–17. doi:10.1007/s00403-012-1266-9.

    Article  CAS  PubMed  Google Scholar 

  16. Knaak JP, Timchalk C, Tornero-Velez R, Ngo MA, Maibach HI. 15 factors of percutaneous penetration of pesticides. In: Parameters for pesticide QSAR and PBPK/PD models for human risk assessment, vol. 1099. ACS Symposium Series. American Chemical Society, Oxford Press, Oxford, Great Britain; 2012:67–86. ccessed 5 March 2014.

    Google Scholar 

  17. Garland MJ, Migalska K, Tuan-Mahmood TM, et al. Influence of skin model on in vitro performance of drug-loaded soluble microneedle arrays. Int J Pharm. 2012;434(1–2):80–9. doi:10.1016/j.ijpharm.2012.05.069.

    Article  CAS  PubMed  Google Scholar 

  18. Levin J, Maibach H. Interindividual variation in transdermal and oral drug deliveries. J Pharm Sci. 2012;101(11):4293–307. doi:10.1002/jps.23270.

    Article  CAS  PubMed  Google Scholar 

  19. Schneeweiss S, Gagne JJ, Glynn RJ, Ruhl M, Rassen JA. Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development. Clin Pharmacol Ther. 2011;90(6):777–90. doi:10.1038/clpt.2011.235.

    Article  CAS  PubMed  Google Scholar 

  20. Shaw DW, Maibach HI. Clinical relevance of tixocortol pivalate-positive patch tests and questionable bioequivalence of different hydrocortisone preparations. Contact Dermatitis. 2013;68(6):369–75. doi:10.1111/cod.12066.

    Article  CAS  PubMed  Google Scholar 

  21. Stoughton RB. The vasoconstrictor assay in bioequivalence testing: practical concerns and recent developments. Int J Dermatol. 1992;31(Suppl. 1):26–8.

    Article  PubMed  Google Scholar 

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Author information

Authors and Affiliations

  1. Department of Dermatology, University of California-San Francisco, 94143, San Francisco, CA, USA

    Garrett Coman & Nicholas Blickenstaff

  2. School of Medicine, University of Utah, Salt Lake City, Utah, USA

    Garrett Coman & Nicholas Blickenstaff

  3. Department of Dermatology, School of Medicine, University of California, San Francisco, CA, USA

    Howard I. Maibach MD

Authors
  1. Garrett Coman
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  2. Nicholas Blickenstaff
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  3. Howard I. Maibach MD
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Corresponding author

Correspondence to Garrett Coman .

Editor information

Editors and Affiliations

  1. Pharmaceutical Consultant, North Potomac, Maryland, USA

    Vinod P. Shah

  2. University of California, San Francisco School of Medicine, Department of Dermatology, San Francisco, California, USA

    Howard I. Maibach

  3. The Defence Science and Technology Laboratory, Biomedical Sciences Department, Salisbury, United Kingdom

    John Jenner

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Coman, G., Blickenstaff, N., Maibach, H. (2014). Challenges with Clinical Endpoints—Bioequivalence. In: Shah, V., Maibach, H., Jenner, J. (eds) Topical Drug Bioavailability, Bioequivalence, and Penetration. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1289-6_20

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