C of A [GxP / QC / QA]
Dear Ohlbe
I guess the (reference) drug was purchased from the local market, right? So the originator analysed the product (batch) in order to release it. Every physician prescribing this product has to rely on this procedural step and by this on the quality. Since this is a registrated and marketed product I can see no ethical concern as long as the product is not manipulated before administration.
Kind regards
Dan
❝ Giving subjects a drug which has not been analysed or properly identified is of concern.
I guess the (reference) drug was purchased from the local market, right? So the originator analysed the product (batch) in order to release it. Every physician prescribing this product has to rely on this procedural step and by this on the quality. Since this is a registrated and marketed product I can see no ethical concern as long as the product is not manipulated before administration.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan