jag009 ★★★ NJ, 2020-02-20 20:59 (1498 d 02:22 ago) (edited by jag009 on 2020-02-20 23:12) Posting: # 21185 Views: 1,864 |
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Hi, Question: For the development of a fixed dose combination (FDC) product containing two ingredient, is there a need to do pediatric PK study
Thx J |
Dr_Dan ★★ Germany, 2020-03-03 16:53 (1486 d 06:27 ago) @ jag009 Posting: # 21197 Views: 1,075 |
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Hi John In principle there is a need for a PIP for all new drug products except generics so also for fixed dose combination (FDC) products, especially if the individual references' dosages are applicable to adolescent and are commonly used together. I am not talking about PK studies but efficacy(!). The fact that the new FDC will have a new dosing interval does not make any difference. Of course you can apply for a PIP-waiver but what would be the arguments? Why should the new product be kept from children? Just saving time and money will not convince PDCO. — Kind regards and have a nice day Dr_Dan |