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1 0 0 0 OA 核酸医薬品の現状と品質管理に関わるレギュラトリーサイエンス上の課題

著者: 藤坂朱紀伊藤浩介小比賀聡
出版者: 一般社団法人レギュラトリーサイエンス学会
雑誌: レギュラトリーサイエンス学会誌 (ISSN:21857113)
巻号頁・発行日: vol.7, no.2, pp.113-120, 2017 (Released:2017-05-31)
参考文献数: 32
被引用文献数: 1

核酸医薬品は, 低分子医薬品や抗体医薬に次ぐ新たなカテゴリーの医薬品として, 近年大きな注目を集めている. 実際に承認された核酸医薬品はこれまでのところ世界的にも5品目と少ないものの, 国内外における核酸医薬品の臨床試験は現在百数十件にも達しており, その勢いは今後も衰えることはないであろう. しかし, 現在のところ核酸医薬品を主たる対象としたガイドラインは存在していないため, 核酸医薬品開発に関わる品質, 非臨床安全性, 臨床的特徴を整理し検討しておくことは核酸医薬品の研究開発を進めるうえで重要である. 本稿では, 核酸医薬品の開発の現状を概説するとともに, 核酸医薬品に関わるレギュラトリーサイエンス上の課題点について, 特に品質管理の立場から, 合成・精製, および分析上の課題, 化学修飾に基づく課題, 高次構造の管理などのいくつかのポイントについて議論する.

2021-11-13 06:28:27
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1 0 0 0 OA ヘブル語聖書における「笛」「フルート」の釈義的考察

著者: 竹内茂夫
出版者: 一般社団法人日本オリエント学会
雑誌: オリエント (ISSN:00305219)
巻号頁・発行日: vol.52, no.1, pp.105-118, 2009-09-30 (Released:2014-03-31)
参考文献数: 37

This paper aims to re-examine three Hebrew words in the Hebrew Bible which are usually translated as “flute” or “pipe”. First, ‘ûgāb (attested four times in the Hebrew Bible and once in 11QPsa/11Q5), could in fact refer to a chordophone rather than to an aerophone, since in the Septuagint it is rendered as κιθαρα “lyre, harp” on one occasion, whilst it occurs twice as οργανον “tool” and a further two time as ψαλμος “song (sung to the harp), psalm” In addition, words clearly referring to chordophones such as kinnôr “lyre” or minnîm “stringed instruments” are always found paired with ‘ûgāb. Secondly, nəḥîlôt (attested once) occurs as ’el-hannəḥîlôt with the preposition ’el- “to (ward)” and the definite article haC-. Is is said that its meaning is “difficult” or “uncertain”. Even so, it has been translated as “flute” from the supposed Hebrew root ḥ-l-l like ḥālîl or as “inheritance” from the n-ḥ-l found in the Septuagint. Although the meaning of nəḥîlôt itself remains open to question, ’el-hannəḥîlôt as a whole may refer to the incipit of an unknown tune. Thirdly, ḥālîl (attested five times) is translated as αυλος “double-pipe” in the Septuagint. This meaning is quite plausible as there are archaeological evidence of existence of the double-pipe in the Syria-Palestine area. It is not unlikely that the fairly modest number of attestations of words referring to ‘flute’ or ‘pipe’, (less than 10 in the Hebrew Bible) is due to the fact that such words are easily associated with erotic or intoxicating objects, rather than with musical instruments such as these were known in Egypt and Greece.