必殺仕事人 （株式投資激闘編）の掲示板
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>>1361
FDA will accept two to four paired meeting requests quarterly each year through June 15, 2022, with an initial focus on dose selection, clinical trial simulation and predictive or mechanistic safety evaluation.
The agency held a joint workshop in February with the International Society of Pharmacometrics to discuss MIDD for oncology products, as models can support dosing decisions and help companies make faster, better decisions about which products and combinations to take forward. FDA officials championed MIDD as a means to determine the optimal use of new products when scant clinical data leave unanswered questions.
One way companies and FDA are using MIDD is to model the phenomena that explain how tumor sizes and rates of growth change over time. This modeling of tumor kinetics gives more information about how tumors respond to treatments than RECIST criteria. As a result, these models can allow companies and regulators to draw more conclusions from their data. -
>>1361
マーケティングに精通した臨床プロマネ経験者と、、、
臨床薬理・薬物動態のBackgroundのあるTranslational research、Initiation経験者、、、
薬事（Ragulatory science）のわかる試験統計家Statistician、、、
３人で起業するか？？？
ｗｗｗ
kaz*ヒト投与可能で一斉摘発ｗ
開発の初期段階から非臨床データや臨床データを統合的にあてはめて最適解を求めていくアプローチであるMID3
それの試験的評価がFDAでもう始まったそうなｗｗｗ
日本のベンチャーでここまで対応出来そうなのところはないので、これのベンチャー起こしたらイケんじゃね？
FDA launches model-informed drug development pilot
FDA began a model-informed drug development (MIDD) pilot program to facilitate the development and application of exposure-based, biological and statistical models derived from preclinical and clinical data sources.
The agency committed to a series of workshops to enhance the use of MIDD under PDUFA VI, which was included as part of the FDA Reauthorization Act of 2017 (see BioCentury Extra, Aug. 18, 2017).
The pilot aims to provide an opportunity for drug developers and FDA to discuss MIDD approaches to drug development and regulatory evaluation, as well as advice about how particular MIDD approaches can be used in a specific development program.