Transcription of Q&A - nihs.go.jp
1 Q&A Q-1 (A) pH Q-2 (A) in vitro in vivo in vitro A pH 1 B B C 85
2 C C 30 85 D 30 85 % D Q-3 FDA SUPAC-IR, SUPAC-MR * * SUPAC-IR: Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation, November, 1995.
3 SUPAC-MR: Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation, September 1997. (A) [ ] SUPAC 2 10 % [ ] (1) Biopharmaceutics classification system BCS * SUPAC BCS BCS SUPAC in vivo-in vitro In vivo-in vitro BCS B * Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System, August 2000, FDA.
4 (2) SUPAC (3) SUPAC GMP 3 Q-4 (A) Q-5 (A) Q-6 (A)
5 Q-7 (A) Q-8 55 5 30 (A) 4 Q-9 (A) Q-10 10 mg 20 mg 10 mg 20 mg (A) 20mg 10mg Q-11 20 mg 10 mg (A) Q-12 (A)
6 Q&A Q-15 Q-13 (A) 5 15 85 % Q A Q44 Q-14 (A) Q-15 (A) 15 85 Appendix C Q-16 (A) Q-17 (A) Q-18 (A)
7 6 in vitro Q-19 (A) 25% Q-20 (A) Q-21 (A) * *21 CFR (c) Q-22 (A) Q-23 7 (A)
8 D in vitro Q-24 (A) Q-25 Q-25 (A) HPMC 2 8 Q-26 E (A) Q-27 2 (A)
9 PH AEA E Q-28 (A) Q-29 (A) Q-30 (A) 9 Q-31 (A) S0 W0, D0 S W D S/S0 ((W/D /(W0/D0)))
10 2/3 h0 h/h0 w0 d0 w d (w/d /(w0/d0)) ((W/D /(W0/D0))2/3 h/h0 (w/w0) (W0/W)2/3 Q-32 (A))
