Sampling times and genotyping concerns in bioequivalence evaluation of branded and generic formulations

Zhao, Xiaoying; Xu, Huimin; Zhou, Quan

doi:10.2147/tcrm.s54607

Cited by 3 publications

(2 citation statements)

References 16 publications

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“…The most common reason for supporting local generics reported by both physicians and patients in this study, was cost. Other studies have also found that price differences influence physician prescribing of generics [ 34 , 35 ].…”

Section: Discussionmentioning

confidence: 99%

Views and perceptions about locally manufactured medicines in Ethiopia: a qualitative study of physicians, patients and regulatory authorities

Alemayehu

Mitchell

Nikles

et al. 2018

BMC Health Serv Res

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BackgroundBecause of their cost, the use of locally produced, bioequivalent, generic drugs is universally recommended. In Ethiopia. while the government is committed to raising the market share and use of locally produced drugs, the process is hampered by the lack of a bioequivalence testing centre to strengthen the regulatory environment and deliver quality-assured local medicines. The purpose of this study is to assess the views and perceptions of key regulatory stakeholders, physicians and patients about locally produced generic medicines.MethodsA descriptive qualitative study, using focus group discussions and key informant interviews, was conducted. Five key informant interviews (two senior regulatory authority members and 3 institutional review board members) as well as 4 focus group discussions (2 with physicians and 2 with patients) were held. Data were analysed using an inductive, thematic process.ResultsFour major themes emerged: awareness of lack of bioequivalence profiles associated with local medicines, perceptions about the quality and effectiveness of local medicines, quality and efficacy of imported medicines from developing countries and quality and efficacy of cheaper medicines. All institutional review board members were aware of bioequivalence issues. However, many physicians lacked detailed knowledge about bioequivalence, its clinical relevance and the lack of bioequivalence data for local medicines. All institutional review board members, physicians and male patients, but not female patients, were concerned about the quality and effectiveness of local medicines. Female patients were more confident about the locally produced drugs. In addition, some physicians and patients were not confident about the quality and effectiveness of cheaper drugs and drugs imported from developing countries. Government officials believed that local drugs are reliable.ConclusionThe success of promoting the use of inexpensive local medicines and changing the perception of the community depends not only on increasing the domestic market share held by local companies, but also on the capacity of the regulatory environment and companies to produce quality assured medicines and to overcome misconceptions. Among other initiatives, establishing an accredited bioequivalence centre in the country needs to be addressed urgently.

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Section: Discussionmentioning

confidence: 99%

Views and perceptions about locally manufactured medicines in Ethiopia: a qualitative study of physicians, patients and regulatory authorities

Alemayehu

Mitchell

Nikles

et al. 2018

BMC Health Serv Res

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show abstract

“… 8 – 11 We reported that incidence rate of CYP2C19 poor metabolizers in Chinese populations is far higher than that in Caucasians (25% versus 2%–5%) and it is very necessary to perform genotyping of CYP2C19 prior to initiation of clopidogrel treatment in Chinese subjects. 12 The new clinical algorithm comprising CYP2C19 pharmacogenetics and drug interactions developed by Saab et al is very practical and beneficial in optimizing clopidogrel treatment. 1 Their study along with our perspectives may bring a more detailed guide in personalized antiplatelet therapy.…”

Section: Use Of Oral Suspensionmentioning

confidence: 99%

The use of oral suspension and rationally prescribing alternatives may be supplemental to the implementation of clopidogrel new algorithm comprising CYP2C19 pharmacogenetics and drug interactions

Chen

Zhou

2016

TCRM

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Is Promethazine 6.25 mg Intravenous Dose Really Ideal to Treat Postoperative Nausea and Vomiting?

Zhu

Chen

Zhou

2015

Journal of PeriAnesthesia Nursing

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Sampling times and genotyping concerns in bioequivalence evaluation of branded and generic formulations

Cited by 3 publications

References 16 publications

Views and perceptions about locally manufactured medicines in Ethiopia: a qualitative study of physicians, patients and regulatory authorities

Views and perceptions about locally manufactured medicines in Ethiopia: a qualitative study of physicians, patients and regulatory authorities

The use of oral suspension and rationally prescribing alternatives may be supplemental to the implementation of clopidogrel new algorithm comprising CYP2C19 pharmacogenetics and drug interactions

Is Promethazine 6.25 mg Intravenous Dose Really Ideal to Treat Postoperative Nausea and Vomiting?

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