Aug 17, 2010 08:08
13 yrs ago
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Japanese term

新薬収載希望者による市場規模予測

Japanese to English Medical Medical (general) 薬価算定
「新医薬品の薬価算定について」という書類の中に書かれているのですが、翻訳案がありましたら、よろしくお願いします。
見出しの一つなので、できるだけ簡潔な表現をご提案いただけたら幸いです。

Proposed translations

32 mins
Selected

market size prediction upon new drug prescription applicants

The generic drug share of prescription drug volume has increased by ... Total generic drug market share has increased as well in the years since ... depending upon the circumstance, (1) the 30-month stay of ANDA --- drug price is determined based on market size.
Example sentence:

This process requires an ANDA (Abbreviated new drug applications) filing ... the class of drug; historic, current and potential market size; ... prescription to over-the-counter status and details the resulting market ... new Rx-to-OTC drug switches strat

For standard new drug applications, the median approval time was 22 months in FY1993.

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4 KudoZ points awarded for this answer. Comment: "Many thanks, Soonthon and everyone. All answers, references and explanation provided are extremely helpful."
17 hrs

The maker's prediction of market size for a prospective new NHI drug price listing

This is the kind of Japanese that is really difficult to turn into elegant English, and I would probably rewrite this completely in translating a longer text. The important point is that 新薬収載 refers to an NHI drug price listing, since this is where the prediction of market size is relevant (for pricing). This comes after approval of the new drug application (新薬承認申請, which is concerned with safety, efficacy etc).
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19 hrs

drug market size forecast prepared by the Marketing Authorization Holders

新医薬品(薬事法(昭和35年法律第145号)第14条の4第1項に掲
げる医薬品をいう。以下同じ。)の薬価基準への収載手続きは、新医薬品の
収載を希望する製造販売業者(以下「新薬収載希望者」という。)が、別紙
様式1又は2に定める薬価基準収載希望書を提出することにより行われるも
のであること。
http://www.mhlw.go.jp/shingi/2010/02/dl/s0212-4j.pdf
http://yakuji.exblog.jp/6977077/
http://www.fpmaj.gr.jp/jisyu/documents/nye224_000.pdf
http://www.cde.org.tw/uploadfile/forums/970811/4.pdf
http://www.wam.go.jp/wamappl/bb11GS20.nsf/0/f8e5c7187f774bdb...$FILE/shiryou1_2.pdf
http://masaki.muto.net/lecture/20100423a.pdf
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