Sitter på urtråkig läkemdelstillverkningskonferens så jag passar på att svara på stabilitetsfrågan.
1. När ett nytt lm utvecklas är det jättebråttom och man försöker få med så mycket och långa stabilitetsdata som det bara går. Hur det skall ske regleras av ett dokument som heter ICH Q1(A-F).
2. När man fått ut sin produkt på marknaden måste man ha ett stabilitetsprogram under produktens livstid. Finns också reglerat på samma ställe.
Det man testar är att lm håller sig inom sin produktspecifikation under den angivna hållbarhetstiden, t ex inte bryts ned mer än 5% från nominell dos (om det är den spridning som tillåts i produktspecen.)
3. Om man skall förlänga sin hållbarhetstid måste man skicka in en variation till myndigheterna. Det kräver ganska mycket dokumentation och ökar såklart rsiken att hamna utanför spec och tvingas återkalla produkter. Om man ändå säljer och tjänar pengar krävs det nog ett ganska bra ekonomiskt skäl till en sådan ändring.
Kontentan är att de flesta lm, om de förvarats på det sätt de skall, troligen kan användas långt efter det att bäst-före-datumet går ut. Det som troligast händer är att det bara finns lite mindre aktiv substans i dem än det står på etiketten.
Kan de bli giftiga? Troligen inte. Om de utsätts för en felaktig miljö (hög värme eller någon gas eller något sådant, kan det hända att en substans reagerar eller bryts ned till en annan substans, men vilken det skulle bli och vilka effekter en sådan skulle få på kroppen är nästan omöjligt att förutsäga. Det kan man bara spekulera i. Det finns några vandringslegender, men det är tveksamt om de är sanna.)
Det var lite snabbt. Någon annan kanske vet mer 🙂
/Magnus
Kanske skall tillägga att jag inte rekommenderar någon att strunta i bäst-före-datum 😉 Man måste ha bra koll på terapeutiska fönster, nedbrytningshastighet osv för att ta risken. Insulin, t.ex skall man inte gambla med. Det bryts ned snabbt och konsekvenserna av att ta lågpotent insulin kan vara fatala …
/Magnus
Hejsan!
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Jag har länge velat bli läkare och har sökt samtliga utbildningar i Sverige (och PIL) till våren. Skulle inte ni kunna prata lite om hur det var att studera till läkare på er tid?
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Sitter på urtråkig läkemdelstillverkningskonferens så jag passar på att svara på stabilitetsfrågan.
1. När ett nytt lm utvecklas är det jättebråttom och man försöker få med så mycket och långa stabilitetsdata som det bara går. Hur det skall ske regleras av ett dokument som heter ICH Q1(A-F).
2. När man fått ut sin produkt på marknaden måste man ha ett stabilitetsprogram under produktens livstid. Finns också reglerat på samma ställe.
Det man testar är att lm håller sig inom sin produktspecifikation under den angivna hållbarhetstiden, t ex inte bryts ned mer än 5% från nominell dos (om det är den spridning som tillåts i produktspecen.)
3. Om man skall förlänga sin hållbarhetstid måste man skicka in en variation till myndigheterna. Det kräver ganska mycket dokumentation och ökar såklart rsiken att hamna utanför spec och tvingas återkalla produkter. Om man ändå säljer och tjänar pengar krävs det nog ett ganska bra ekonomiskt skäl till en sådan ändring.
Kontentan är att de flesta lm, om de förvarats på det sätt de skall, troligen kan användas långt efter det att bäst-före-datumet går ut. Det som troligast händer är att det bara finns lite mindre aktiv substans i dem än det står på etiketten.
Kan de bli giftiga? Troligen inte. Om de utsätts för en felaktig miljö (hög värme eller någon gas eller något sådant, kan det hända att en substans reagerar eller bryts ned till en annan substans, men vilken det skulle bli och vilka effekter en sådan skulle få på kroppen är nästan omöjligt att förutsäga. Det kan man bara spekulera i. Det finns några vandringslegender, men det är tveksamt om de är sanna.)
Det var lite snabbt. Någon annan kanske vet mer 🙂
/Magnus
Tusen tack Magnus för kanonbra svar. Vi kommer troligen återkoppla några av dem i nästa avsnitt!
/Christian
Kanske skall tillägga att jag inte rekommenderar någon att strunta i bäst-före-datum 😉 Man måste ha bra koll på terapeutiska fönster, nedbrytningshastighet osv för att ta risken. Insulin, t.ex skall man inte gambla med. Det bryts ned snabbt och konsekvenserna av att ta lågpotent insulin kan vara fatala …
/Magnus
Hejsan!
Började lystna på er podcast igår, och har redan plöjt igenom runt tio avsnitt. Jättebra och intressant podcast!
Jag har länge velat bli läkare och har sökt samtliga utbildningar i Sverige (och PIL) till våren. Skulle inte ni kunna prata lite om hur det var att studera till läkare på er tid?
Ciao
kul att du gillar. jo, bra tema. Tillbakablick kanske det får bli:)
/Christian
Fick tips om er podcast via en kollega, väldigt kul att lyssna på er måste jag säga. 🙂
Kul att du gillar! Vad jobbar du själv med?!
Jag studerar till rtgssk men jobbar extra på röntgen som uska.
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