Microdosing studyマイクロドーズ臨床試験Exploratory clinical study探索的臨床試験Cassette dosing studyカセットドーズ臨床試験
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LEXICON
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G1/G2 RuleG1/G2ルールMarch 9, 2018
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New PMP Criteria新薬創出加算の新要件March 9, 2018
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Cost-Based Method原価計算方式July 27, 2017
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Sakigake Designation Scheme先駆け審査指定制度August 17, 2016
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Special expansion re-pricing (Huge-seller re-pricing)特例拡大再算定（巨額再算定）March 4, 2016
While Japan has now granted its first emergency approval to Shionogi’s COVID-19 pill Xocova (ensitrelvir), the drug failed to win a unanimous vote by advisory panels, with skepticism lingering over its actual efficacy. To prep for the next emergency, which…
As the year 2022 draws to a close, what are managers thinking at the world’s leading pharmaceutical companies and medical device companies? We surveyed 86 managers at these companies to find out what’s on their minds.For many managers, a common…
A Japanese reimbursement policy panel on November 16 saw a continued scuffle between members representing healthcare providers and payers over…
Deloitte Tohmatsu Consulting proposed three drug pricing schemes designed to trigger the consolidation of generic makers on October 27, offering…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…