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

• Main Authors: Asami Ono (Author), Naoya Matsumura (Author), Takahiro Kimoto (Author), Yoshiyuki Akiyama (Author), Satoko Funaki (Author), Naomi Tamura (Author), Shun Hayashi (Author), Yukiko Kojima (Author), Masahiro Fushimi (Author), Hiroshi Sudaki (Author), Risa Aihara (Author), Yuka Haruna (Author), Maiko Jiko (Author), Masaru Iwasaki (Author), Takuya Fujita (Author), Kiyohiko Sugano (Author)
• Format: Book
• Published: International Association of Physical Chemists (IAPC), 2019-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...