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RegisterAdverse event [GxP / QC / QA]
Dear Bhavesh
According to ICH GCP Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
May be as u said the abnormality in the lab investigations is not because of the drug concentration we shall treat it as an adverse event only.
There are so many reasons for the change in the lab investigations other than the drug effect. It may be due to changes in the dietary habits etc.,
From the available literature of the past studies we can predict the possible side effects. If the abnormalities in the lab investigations are observed in the past studies we can say it is due to drug otherwise we need to investigate the cause of the abnormalities.
Thanks®ards
KK
According to ICH GCP Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
May be as u said the abnormality in the lab investigations is not because of the drug concentration we shall treat it as an adverse event only.
There are so many reasons for the change in the lab investigations other than the drug effect. It may be due to changes in the dietary habits etc.,
From the available literature of the past studies we can predict the possible side effects. If the abnormalities in the lab investigations are observed in the past studies we can say it is due to drug otherwise we need to investigate the cause of the abnormalities.
Thanks®ards
KK
Complete thread:
- Adverse event Bhavesh 2009-08-14 05:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Adverse eventkiranActimus 2009-08-14 10:14
- Adverse event Bhavesh 2009-08-17 07:41
- Adverse event kiranActimus 2009-08-17 09:02
- Adverse event taresh41 2009-08-17 13:13
- Adverse event Bhavesh 2009-08-17 07:41
- Adverse eventkiranActimus 2009-08-14 10:14
Ing. Helmut Schütz