言葉の定義－－－同等性・同質性に---をコピペ

自分たちがいつも意識しているのは、comparability。

Sameness [identical]（同一性） => バイオ医薬品では適用不可

Similarity Similarity（同等性/同質性）=>バイオシミラ のー比較に適用

Comparability（同等性/同質性）

=>ICH-Q5Eで同一製造者における軽微変更での比較に適用

（ただし、日本のガイドラインはICH-Q5Eの概念を延長）

In practice, the terms biosimilarity (similarity), bioequivalence (equivalence), and comparability (consistency) are used interchangeably in pharmaceutical research and development. For comparison between drug products, some criteria for assessment of bioequivalence (e.g. drug absorption profiles comparison), similarity (e.g. dissolution profiles comparison), and comparability or consistency (e.g. comparison between product protein structures and function) are available in either regulatory guidelines/guidances or literature.