ADMET & DMPK

ADMET & DMPK

Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan

Yazarlar: Asami Ono, Naoya Matsumura, Takahiro Kimoto, Yoshiyuki Akiyama, Satoko Funaki, Naomi Tamura, Shun Hayashi, Yukiko Kojima, Masahiro Fushimi, Hiroshi Sudaki, Risa Aihara, Yuka Haruna, Maiko Jiko, Masaru Iwasaki, Takuya Fujita, Kiyohiko Sugano

Cilt 7 , Sayı 3 , 2019 , Sayfalar 183-195

Konular:-

DOI:10.5599/admet.704

Anahtar Kelimeler:Shake-flask solubility,Equilibrium solubility,Poorly water-soluble drugs

Özet: The purpose of the present study was to harmonize the protocol of equilibrium solubility measurements for poorly water-soluble drugs to lower inter-laboratory variance. The “mandatory” and “recommended” procedures for the shake-flask method were harmonized based on the knowledge and experiences of each company and information from the literature. The solubility of model drugs was measured by the harmonized protocol (HP) and the non-harmonized proprietary protocol of each company (nonHP). Albendazole, griseofulvin, dipyridamole, and glibenclamide were used as model drugs. When using the nonHP, the solubility values showed large inter-laboratory variance. In contrast, inter-laboratory variance was markedly reduced when using the HP.

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@article{2019, title={Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan}, volume={7}, number={183–195}, publisher={ADMET & DMPK}, author={Asami Ono, Naoya Matsumura, Takahiro Kimoto, Yoshiyuki Akiyama, Satoko Funaki, Naomi Tamura, Shun Hayashi, Yukiko Kojima, Masahiro Fushimi, Hiroshi Sudaki, Risa Aihara, Yuka Haruna, Maiko Jiko, Masaru Iwasaki, Takuya Fujita, Kiyohiko Sugano}, year={2019} }
APA
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Asami Ono, Naoya Matsumura, Takahiro Kimoto, Yoshiyuki Akiyama, Satoko Funaki, Naomi Tamura, Shun Hayashi, Yukiko Kojima, Masahiro Fushimi, Hiroshi Sudaki, Risa Aihara, Yuka Haruna, Maiko Jiko, Masaru Iwasaki, Takuya Fujita, Kiyohiko Sugano. (2019). Harmonizing solubility measurement to lower inter-laboratory variance – progress of consortium of biopharmaceutical tools (CoBiTo) in Japan (Vol. 7). Vol. 7. ADMET & DMPK.
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Asami Ono, Naoya Matsumura, Takahiro Kimoto, Yoshiyuki Akiyama, Satoko Funaki, Naomi Tamura, Shun Hayashi, Yukiko Kojima, Masahiro Fushimi, Hiroshi Sudaki, Risa Aihara, Yuka Haruna, Maiko Jiko, Masaru Iwasaki, Takuya Fujita, Kiyohiko Sugano. Harmonizing Solubility Measurement to Lower Inter-Laboratory Variance – Progress of Consortium of Biopharmaceutical Tools (CoBiTo) in Japan. no. 183–195, ADMET & DMPK, 2019.
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