jag009 ★★★ NJ, 2018-09-07 22:31 (2055 d 14:50 ago) Posting: # 19251 Views: 2,161 |
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Hi, Question. To support SUPAC (post approval manufacturing site change) filing for ER products, do we need to perform multimedia dissolution testings? Thanks John |
Helmut ★★★ Vienna, Austria, 2018-09-09 16:04 (2053 d 21:17 ago) @ jag009 Posting: # 19253 Views: 1,792 |
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Hi John, ❝ To support SUPAC (post approval manufacturing site change) filing for ER products, do we need to perform multimedia dissolution testings? Generally not. That’s a Level 3 Change. See the guidance V. C. 2. b. Dissolution documentation: In addition to application/compendial release requirements, a multipoint dissolution profile should be obtained using application/compendial test conditions for the changed drug product and the biobatch or marketed batch (unchanged drug product). Adequate sampling should be performed, for example at 1, 2, and 4 hours and every two hours thereafter until either 80% of the drug from the drug product is released or an asymptote is reached. But don’t forget V. C. 2. c. Bioequivalence documentation:A single-dose bioequivalence study. The bioequivalence study may be waived in the presence of an established in vitro/in vivo correlation. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
jag009 ★★★ NJ, 2018-09-10 20:38 (2052 d 16:44 ago) @ Helmut Posting: # 19256 Views: 1,738 |
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Thank Helmut! |