Same Drug, Different Dosing: Differences in Dosing for Drugs Approved in the United States, Europe, and Japan

Malinowski, H.; Westelinck, Agnes; Sato, Junko; Ong, Ting Eng

doi:10.1177/0091270008319794

Cited by 69 publications

(74 citation statements)

References 5 publications

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“…The lower maximum daily doses in Japan than those in the US, as observed in the present and other studies (10,11), is another hindrance to the development of neurological drugs in Japan. Although we found no statistically significant effect of the maximum doses on the lag and review time in the present study, differences in doses between the two regions often result in difficulties in extrapolating data from one region to the other.…”

Section: Discussionsupporting

confidence: 65%

“…Although we found no statistically significant effect of the maximum doses on the lag and review time in the present study, differences in doses between the two regions often result in difficulties in extrapolating data from one region to the other. Although the difference in doses (10,11) could affect clinical development time in Japan, no study provides direct evidence for such effect. First, we could not precisely identify the development time, since the starting date of clinical development is confidential.…”

Section: Discussionmentioning

confidence: 99%

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Delays in Neurological Drug Development in Japan

Shimazawa

Ikeda

2011

Intern. Med.

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Objective The lag in the approval and development of neurological drugs between Japan and other countries has been a major issue for patients with neurological diseases. The objective of this study was to analyze the factors contributing to the delay in the launching of neurological drugs in Japan. Methods We analyzed data from Japan and the US for the approval of 36 standard neurological drugs and examined the potential factors that may cause the delay of their launch. Results Of the 36 standard neurological drugs, all of which were approved in the US, only 21 were introduced in Japan from June 1999 to April 2010, whereas the other 15, whose indications were Alzheimer disease, epilepsy, migraine, multiple sclerosis, and Parkinson disease, remained unapproved. The US led Japan in the number of introductions (20 versus 1), with introductions in Japan occurring at a median of 87 months after introductions in the US. Japan's review time of new drug applications (23 months) could not explain this lag. In 15 of the 21 approved drugs, the application data package included overseas data. The mean review time of these 15 drugs was significantly shorter than that of the other 6 drugs without overseas data. The maximum daily doses of 7 of the drugs were higher in the US than in Japan. Conclusion These results show that there is still a large gap between Japan and the US with regard to access to standard neurological drugs, despite several important reforms in the Japanese drug approval system.

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Section: Discussionsupporting

confidence: 65%

Section: Discussionmentioning

confidence: 99%

Delays in Neurological Drug Development in Japan

Shimazawa

Ikeda

2011

Intern. Med.

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“…Common examples in this respect would be the difference between medical practices in Japan and those in the United States and Europe. Studies have shown that there are differences in drug dosing between the United States, Europe, and Japan [81,82,83]. For 32% of drugs approved between 2001 and 2007, the maximum recommended dose in the United States was at least twice as high as in Japan [83].…”

Section: Differences In Medical Practicementioning

confidence: 99%

The Importance of Ethnicity Definitions and Pharmacogenomics in Ethnobridging

et al. 2013

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“…The FDA has 30 days to respond to the IND and may request additional information or clarifications, or request the sponsor to address any concerns; the sponsor must address these issues adequately before the trial can start. If the sponsor does not receive a response from the FDA within 30 days of receipt of the IND, the sponsor can start the human clinical study (for differences in the drug approval process and drug dosing between FDA, European Medicines Agency [EMEA; Europe] and Product Development and Management Association [PDMA; Japan] see [6][7][8] ).…”

Section: Dovepressmentioning

confidence: 99%

Pharmacological modeling and biostatistical analysis of a new drug

Ananthakrishnan¹,

Gona²

2010

OAJCT

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Clinical research and clinical trials of experimental drugs to treat human diseases have gained greater importance in recent years. Phase I-IV clinical trials offer patients the opportunity to gain access to a new, more efficacious and safer medication to alleviate or cure their disease. There are potential side effects of every new drug; however, such trials and studies are crucial for drug development and testing in humans. The US Food and Drug Administration (FDA) regulated process of evaluating a new drug for treating a particular disease in humans is long, rigorous, and includes the stages starting from preclinical research through the entire human clinical trials process. This review synthesizes results from the above stages and describes the entire mechanism of the clinical study of a new drug for human disease. It emphasizes the associated mathematical modeling and statistical analyses, and bridges pharmacological modeling and biostatistics in clinical research and also provides a basic theoretical overview to biomedical experimentalists. The modern trend in clinical research involves a unified approach among several biomedical subspecialties and it is hoped that even more integrated studies of new drugs will continue to be carried out, leading to novel drugs that are highly effective in curing the associated condition.

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Same Drug, Different Dosing: Differences in Dosing for Drugs Approved in the United States, Europe, and Japan

Cited by 69 publications

References 5 publications

Delays in Neurological Drug Development in Japan

Delays in Neurological Drug Development in Japan

The Importance of Ethnicity Definitions and Pharmacogenomics in Ethnobridging

Pharmacological modeling and biostatistical analysis of a new drug

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