Search Results - "Shimojo, Kohei"
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Direct Hydroxylation and Amination of Arenes via Deprotonative Cupration
Published in Journal of the American Chemical Society (27-07-2016)“…Deprotonative directed ortho cupration of aromatic/heteroaromatic C–H bond and subsequent oxidation with t-BuOOH furnished functionalized phenols in high…”
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The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities
Published in Journal of pharmacy & pharmaceutical sciences (21-03-2024)“…Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently…”
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A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme
Published in Journal of pharmacy & pharmaceutical sciences (08-10-2022)“…The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is…”
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A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme
Published in Journal of pharmacy & pharmaceutical sciences (2021)“…The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System…”
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