Forces influencing generic drug development in the United States: a narrative review

Lee, Chia Ying; Chen, Xiaohan; Romanelli, Robert J.; Segal, Jodi B

doi:10.1186/s40545-016-0079-1

Cited by 16 publications

(11 citation statements)

References 9 publications

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“…Overall study showed that there is a lack of awareness, knowledge towards generic medicines amongst the Sulaimani population. This conclusion is in line with the research conducted by Thomas and Vitry 29 for the Malaysian and significantly different than de Lira et al 6 for the Brazilian and Kulikovska et al 19 for the Latvian consumers where they confirmed that the studied population has sufficient knowledge towards generic medicines.…”

Section: Discussionsupporting

confidence: 86%

Use of generic medicines in the Middle East: Knowledge, perceptions and experiences of the Sulaimani population, KRI, Iraq

Uctu

2021

Journal of Generic Medicines

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The aim of this study is to assess the level of knowledge, perception, and experiences of the Sulaimani population in KRI, Iraq. A descriptive and cross-sectional survey was performed with 389 participants (283 male, 106 female) in the city of Sulaimani. The main method of collecting data was done through a questionnaire which was made up of two sections; firstly assessing the demographic characteristics of the sample population, and secondly assessing their knowledge towards generic medicines and their perceptions of generic medicine usage and purchasing intention. The Cronbach’s alpha coefficient was 0.726 which is considered as an acceptable value to measure internal consistency of the sampled population. As a result, this study showed that the sampled population did not have sufficient knowledge about generic medicines and would therefore also not be considering replacing branded medicines with the generics. This is mostly related to poor awareness of generic medicines and lack of publicity or awareness campaigns surrounding generic medicines. This study recommends that authorities invest in publicizing the use of generics and implement public awareness campaigns.

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Section: Discussionsupporting

confidence: 86%

Use of generic medicines in the Middle East: Knowledge, perceptions and experiences of the Sulaimani population, KRI, Iraq

Uctu

2021

Journal of Generic Medicines

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“…Regulatory agencies have adopted an abbreviated approval process for generic drugs (Sravika et al, 2017). Demonstration of bioequivalence (BE) is required for approval of generic drugs, instead of repeating clinical trials on safety and efficacy (Lee et al, 2016). As a result of this abbreviated approval process, generic drugs can be supplied at lower cost.…”

Section: Introductionmentioning

confidence: 99%

“…• When blood samples are used, the comparative evaluation parameters include AUC t and C max in a single dose study, and AUC τ and C ss,max in a multiple-dose study. [Article 17 (Lee et al, 2016)] • When log transformation and statistical evaluation on comparative parameters of the reference and test product except T max are performed, the 90% confidence intervals for the difference in mean values between the test and reference should be within log 0.8 to log 1.25. [Article 17 (Howard et al, 2018)]…”

Section: Introductionmentioning

confidence: 99%

“…• Blood collection shall be conducted with sufficient time period of more than 3 times the elimination half-life or AUC 0-t to reach at least 80% of AUC ∞ . [Article 15 (Lee et al, 2016)] • The number of subjects shall be based on an appropriate sample size calculation and may be added or subtracted depending on types and characteristics of active ingredients. The number, in principle, shall be at least 12 or more.…”

Section: Introductionmentioning

confidence: 99%

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Current Bioequivalence Study Designs in South Korea: A Comprehensive Analysis of Bioequivalence Study Reports Between 2013 and 2019

Huh

Kim²,

Lee³

et al. 2021

Front. Pharmacol.

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Demonstration of bioequivalence (BE) is mandatory while developing generic drugs. The scientific concept of BE applies equally to different regulatory agencies. However, the application of the concept may differ for each agency, which can affect the design of BE studies. To evaluate the study practices in terms of the BE concept in South Korea, we retrospectively analyzed BE study reports available from Ministry of Food and Drug Safety between 2013 and 2019. Statistical estimation of the pharmacokinetic parameters, including peak concentration and area under the concentration–time curve to the last measurable concentration, as well as study design, number of subjects in a study, study duration, fasting status, and formulation of specific drugs were obtained. The drugs were classified per World Health Organization Anatomical Therapeutic Chemical Classification and Biopharmaceutics Classification System. Post-hoc intrasubject coefficient of variation and corresponding sample sizes were calculated from the 90% confidence intervals of pharmacokinetic parameters. A total of 143 generic drugs in 588 BE studies were analyzed. The largest number of studies were performed in the area of Cardiovascular system (172 studies), followed by Nervous system (143 studies) and Alimentary tract and metabolism (92 studies). Overall, BE studies in South Korea were conducted in accordance with the global guideline despite the differences in details. BE studies were focused on the several therapeutic areas and conducted in a similar manner. The number of subjects was generally larger than that estimated with 90% power.

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“…Several strategies or systematic approaches are needed in the form of actions or programs, in order to achieve the objectives of the policy. Some examples include knowledge of the system, policy determinants or political situations that can influence policy, networks that can overcome problems that may arise during the implementation of a policy and the availability of long-term workers who have had a lot of experience with a subsystem (WHO, 2006; Buse et al , 2012; Weible et al , 2012; Lee et al , 2016).…”

Section: Resultsmentioning

confidence: 99%

A predictive policy model to forecast outcomes of drug development in developing countries

Siagian

Besral²,

Achadi³

et al. 2019

IJHG

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Purpose The World Health Organization has pointed out that the majority of developing countries currently rely on imported drugs, in spite of the fact that there is potential for them to produce their own drugs. The purpose of this paper is to present a framework as an innovation policy model that can strategically predict the outcome of drug development investment in developing countries. Design/methodology/approach In order to explore a model relevant to the policy-making process, the literature was systematically reviewed with a focus on the impact of policy changes on drug development in developing countries. Findings An innovation policy model consists of the relational influences of contextual variables of pharma capabilities, innovation incentives and political factors affecting drug development in developing countries, derived from a dissenting policy-making perspective. This was built to test two hypotheses of a positive relationship between the above variables; and a perspectives gap between the pharmaceutical companies and the policymakers. These hypotheses address issues related to the lack of drug development in developing countries. Research limitations/implications This paper presents a conceptual framework for the evaluation and provides examples of its use, but it is currently at a relatively early stage of research. Further work is currently underway and will later be presented to the same journal. Social implications Domestic drug development in developing countries needs to be feasible in order to ensure drug security. This predictive policy model provides a comprehensive approach to health policy reforms to examine innovation strategies. Originality/value This model includes measures to explore whether pharma capabilities, innovation incentives and/or political factors have an effect on domestic drug development in developing countries. It bridges the policy implementation’s operational process between pharmaceutical companies and policymakers.

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Forces influencing generic drug development in the United States: a narrative review

Cited by 16 publications

References 9 publications

Use of generic medicines in the Middle East: Knowledge, perceptions and experiences of the Sulaimani population, KRI, Iraq

Use of generic medicines in the Middle East: Knowledge, perceptions and experiences of the Sulaimani population, KRI, Iraq

Current Bioequivalence Study Designs in South Korea: A Comprehensive Analysis of Bioequivalence Study Reports Between 2013 and 2019

A predictive policy model to forecast outcomes of drug development in developing countries

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