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

Kuribayashi, Ryosuke; Takishita, Tomoko; Mikami, Katsuhiro

doi:10.1016/j.xphs.2016.05.026

Cited by 16 publications

(11 citation statements)

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“…These criteria are adopted for the solid oral dosage forms, including NTID, HVD, and modified-release (MR) products. However, if the second standard is used for ER drug products, the criterion for the dissolution test is stricter than for other oral drug products [ 16 , 20 ].…”

Section: Resultsmentioning

confidence: 99%

“…A characteristic feature of the PMDA is to adopt a second standard. If the first standard, where the 90% CI for the GMR should lie within 80–125%, is not met, the PMDA states that the GMR can lie within 90–111% for the AUC t and C max for all solid oral dosage forms, including HVDs, as long as two other criteria (the subject number and dissolution test results) are satisfied [ 16 , 20 ]. When the second standard is employed, the PMDA requires dissolution similarity, except for ER drug products, for which dissolution equivalency is required.…”

Section: Discussionmentioning

confidence: 99%

“… Bioequivalence studies for solid oral dosage forms [ 16 – 21 ]. Bioequivalence guidelines, guidances, or basic principles regarding various dosage forms [ 16 – 20 , 22 – 33 ]. …”

Section: Methodsmentioning

confidence: 99%

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Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada

Kuribayashi

Appleton

2017

Drugs R D

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PurposeGeneric drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce.ObjectiveThe objective of this study was to examine generic drug reviews in Japan and Canada.MethodsWe surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms.ResultsThis survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities.ConclusionsThe results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada

Kuribayashi

Appleton

2017

Drugs R D

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“…Por definição, os estudos de bioequivalência são ensaios clínicos que visam avaliar os parâmetros farmacocinéticos que interferem na biodisponibilidade de um medicamento e comparar os resultados do medicamento teste com o de referência (5,6). A biodisponibilidade pode ser definida como a velocidade e a extensão com que um fármaco é absorvido e alcança seu local de ação, que pode ser avaliada por meio de medidas farmacociné-ticas capazes de determinar a liberação, absorção e eliminação de um fármaco do organismo (7,8) O estudo de bioequivalência tem uma grande importância para avaliação da segurança e eficácia dos medicamentos.…”

Section: Artigo Originalunclassified

Influência Do Gênero Em Estudos De Bioequivalência De Medicamentos

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Lima

Andrade

et al. 2017

Infarma

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Anatomical and physiological differences between the male and female can change the pharmacokinetic process of a drug and thus interfere with its bioavailability, making a particular drug non-bioequivalent when compared in only one gender. The aim of this study was to evaluate the influence of gender on the bioequivalence study of three drug tests in coated tablet form: Methyldopa 500 mg, Diazepam 10 mg and Scopolamine Butylbromide 10 mg. Therefore, the pharmacokinetic parameters that determine the bioequivalence, ASC0-t, ASC0-∞ and Cmax, were recalculated considering the gender separately. The studies of Diazepam and Scopolamine were bioequivalent for both gender but not bioequivalent when considered only women. Methyldopa's bioequivalence study was not bioequivalent for both sex or for the genders separately. Thus, a more careful evaluation is necessary to analyze and define the bioequivalence of medicines, in order to ensure the efficiency and safety of treatments for both genders.Keywords: Bioequivalence; Methyldopa; Diazepam; Scopolamine Butylbromide RESUMO As diferenças anatômicas e fisiológicas entre os gêneros masculino e feminino podem modificar o processo farmacocinético de um fármaco e assim, interferir em sua biodisponibilidade, tornando um determinado medicamento não bioequivalente quando comparado em apenas um gênero. Dito isto, o objetivo deste trabalho foi avaliar a influência do gênero na bioequivalência de três medicamentos testes na forma de comprimido revestido: Metildopa 500 mg, Diazepam 10 mg e Butilbrometo de Escopolamina 10mg. Para tanto, os parâmetros farmacocinéticos que determinam a bioequivalência, ASC 0-t , ASC 0-∞ e Cmáx, foram recalculados considerando os gêneros em separado. Os estudos do Diazepam e Escopolamina foram bioequivalentes para ambos os sexos, mas bioinequivalentes quando considerado apenas o sexo feminino. O estudo de bioequivalência da Metildopa não foi bioequivalente para ambos os sexos e nem para os sexos em separado. Assim, faz se necessário ampliar as discussões sobre a forma de analisar e definir a bioequivalência de medicamentos a fim de garantir a eficiência e segurança dos tratamentos para ambos os sexos.Palavras-chave: bioequivalência; metildopa; diazepam; butilbrometo de escopolamina INTRODUÇÃOO advento dos genéricos no Brasil, inserido pela Política Nacional de Medicamentos representa um marco importante do Ministério da Saúde na área de produtos farmacêuticos. A lei dos medicamentos Genéricos (Lei nº 9.787/99) teve como objetivo principal estimular a concorrência, como forma de aumentar a variedade de ofertas de medicamentos no mercado, a redução de preços e consequentemente a viabilização do acesso destes medicamentos para população (1,2).

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“…The concept of comparability exercise may be applied for the evaluation of certain nanomedicines such as liposome or block copolymer micelle products (Crommelin et al 2015;Ehmann et al 2013). Continuous provision of guidelines and recent improvement of the reviewing process at the new Office of Generic Drugs in PMDA should reduce the bioequivalence-and quality-related problems particularly for the complex generic drugs (Kuribayashi et al 2016;MHLW 2016c). Since many new generic formulations are developed practically at the same time in different countries, sharing information between the regulatory bodies should be a viable way to reduce the required resources.…”

Section: Future Prospectsmentioning

confidence: 99%

Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan

et al. 2016

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The rapidly growing medical expense going with aging population in Japan requires the use of generic products derived from off-patent active pharmaceutical ingredients (APIs) formulations to reduce the financial burden for the national health insurance system, while at the same time avoiding undermining the quality of medical care. This article provides an overview of the regulatory approaches available to confirm the quality of generic products and gain their greater acceptance by patients. Among several approaches taken by the Ministry of Health, Labor, and Welfare (MHLW), designing systems to supply higher quality products, and providing scientific information to patients and healthcare professionals are key elements to promote the voluntary choice of the generic product. The revision of bioequivalence guidelines and the enhancement of good manufacturing practice (GMP) requirements facilitate the rational development and manufacturing control of generic formulations. A program termed Quality Reevaluation of Ethical Drugs was carried out from 1997 to 2012 using dissolution tests to avoid any significant bioINequivalence between originators and generic oral formulations. The evaluation of product quality and the assessment of the literature information by the Expert Committee on Quality of Generic Drug Products have provided a unique science-based and patient-focused approach for the distribution of reliable generic products. Some current and future issues regarding complex generic drugs are also discussed.

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

Cited by 16 publications

References 5 publications

Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada

Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada

Influência Do Gênero Em Estudos De Bioequivalência De Medicamentos

Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan

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