Hello Christie,
rare side effects are determined by using cohort or case-control studies.
Naranjo is a method to assess the probability an adverse event is correlated to
the drug, but it is used for single cases.
RCT are not ideal for rare side effects as population is limited.
Hope this help. Let me know if you need more information.
best
Felice Musicco
hospital pharmacist
www.ifo.it Rome, Italy
>----Messaggio originale----
>Da: [log in to unmask]
>Data: 09/09/2011 0.08
>A: <[log in to unmask]>
>Ogg: naranjo probability scale
>
>How are a drug's side effects best determined? RCTs would be ideal, but what
about rare but significant side effects that might not turn up in pre-approval
trials? Is the naranjo adverse drug reactions probability scale a valid
method?
>
>I'm interested specifically in side effects from statins.
>
>As always, I appreciate the help and collective wisdom of this group.
>
>cheers,
>Christie
>
>
>Christie Aschwanden
>Email: [log in to unmask]
>Website: www.christieaschwanden.com
>Blog: www.lastwordonnothing.com/category/christie/
>Twitter: cragcrest
>
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