Bioequivalence Requirements in Japan : Background Concepts Hiroyasu Ogata, Ph.D. Professor Emeritus, Meiji Pharmaceutical University Director, Japan Society of Generic Medicines The 15th Annual IGPA Conference 2012, Kyoto, 12.5-7 (2012) Session 6 Bioequivalence 1
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Bioequivalence Requirements in Japan : Background Concepts
Hiroyasu Ogata, Ph.D.
Professor Emeritus, Meiji Pharmaceutical University
Director, Japan Society of Generic Medicines
The 15th Annual IGPA Conference 2012, Kyoto, 12.5-7 (2012)
Session 6 Bioequivalence
1
History of bioequivalence guideline in Japan
Brief overview of bioequivalence studies for products
administered orally in Japan
Participating subjects
Selection of subjects
Number of subjects
Dissolution tests(bio-waiver)
Conclusion
Outlines
2
History of bioequivalence guideline in Japan
Brief overview of bioequivalence studies for products
administered orally in Japan
Participating subjects
Selection of subjects
Number of subjects
Dissolution tests(bio-waiver)
Conclusion
Outlines
3
History of bioequivalence guideline in Japan
Year Subjects Bioequivalence
range Statistics Dissolution
test(bio-waiver)
1974 dog, rabbit ー hypothesis test
1980 humans (dog)
80-120%: normal distribution
hypothesis test + power analysis(Δ = 0.2,1-β >0.8)
1997 humans(patients)
80-125%:log normal distribution
90% confidence interval
2001 humans(patients)
80-125%:log normal distribution
90% confidence interval
similarity, equivalence
2012 humans(patients)
80-125%:log normal distribution
90% confidence interval
similarity, equivalence
4
Guideline for Bioequivalence Studies of Generic Products
(2012/02/29)
Guideline for Bioequivalence Studies of Generic Products for
Different Strengths of Oral Solid Dosage Forms (2012/02/29)
Guideline for Bioequivalence Studies for Formulation Changes
of Oral Solid Dosage Forms (2012/02/29)
Guideline for Bioequivalence Studies for Different Oral Solid
Dosage Forms (2012/02/29)
Bioequivalence Studies of Generic Products for Ethical
Combination Drug Products (2012/02/29)
Bioequivalence Studies for Different Strengths of Ethical
Combination Drug Products and Formulation Changes of
Ethical Combination Drug Products (2012/02/29)
Current Guidelines for Bioequivalence Studies of
Generic Products
Oral solid dosage forms
5
http://www.nihs.go.jp/drug/DrugDiv-E.html
Guideline for Bioequivalence Studies of Generic Topical
Dermatological Drug Products (2006/11/24)
Guideline for Bioequivalence Studies for Different
Topical Dermatological Dosage Forms (2006/11/24)
Guideline for Bioequivalence Studies for Formulation
Changes of Topical Dermatological Drug Products
(2010/11/01)
Current Guidelines for Bioequivalence Studies of
Generic Products
Topical dermatological drug products
6
History of bioequivalence guideline in Japan
Brief overview of bioequivalence studies for products
administered orally in Japan
Participating subjects
Selection of subjects
Number of subjects
Dissolution tests(bio-waiver)
Conclusion
Outlines
7
8 8
◆healthy adult volunteers
◆2x2 cross-over design
◆administered under fasting conditions
◆unchanged active ingredient or a major active metabolite
◆Cmax, AUC
◆acceptance range for each parameter is 0.80 to 1.25
when expressed as the ratio of the parameter’s means
for the test product and reference one
◆90% confidence interval of difference in the average
values of logarithmic parameters to be assessed
between test and reference products is within the
acceptable range of log(0.80) - log(1.25)
Brief overview of bioequivalence studies for
products administered orally in Japan
History of bioequivalence guideline in Japan
Brief overview of bioequivalence studies for products
administered orally in Japan
Participating subjects
Selection of subjects
Number of subjects
Dissolution tests(bio-waiver)
Conclusion
Outlines
9
H.Ogata, N.Aoyagi, N.Kaniwa, M.Koibuchi, T.Shibazaki, A.Ejima, S.Tsuji and