Abstract
Abstract Unexpected drug interactions have led to the withdrawal of many drugs, raising concern about the gap between what is known at the time of approval and the risk of serious effects in the longer term, particularly in high-risk populations generally excluded from drug development. This is because the majority of drug interaction studies are done using in vitro methods, or in healthy young volunteers who may not reflect the complexity of patients, and the settings in which the drug will be used in clinical practice. Pre-marketing interaction studies should therefore be designed to make information easily accessible and clinically transferable. They should be adequate in terms of sample size, population, comorbidity, phenotyping and/or genotyping, end-points and outcome measures, and conducted in conditions of dose, route and timing of co-administration that reproduce the proposed therapeutic indications of the new drug. Although young volunteers have the advantage of minimizing some confounding effects introduced by diseases or polypharmacy, patients drawn from populations for whom the drug is intended would be more relevant and accurate, providing the studies are feasible and safe.
| Original language | English |
|---|---|
| Pages (from-to) | 217-221 |
| Number of pages | 5 |
| Journal | European Journal of Internal Medicine |
| Volume | 24 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Apr 2013 |
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Keywords
- Clinical practice need
- Drug-interactions
- Pre-marketing information
ASJC Scopus subject areas
- Internal Medicine
Cite this
How pre-marketing data can be used for predicting the weight of drug interactions in clinical practice. / Caccia, Silvio; Pasina, Luca; Nobili, Alessandro.
In: European Journal of Internal Medicine, Vol. 24, No. 3, 04.2013, p. 217-221.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - How pre-marketing data can be used for predicting the weight of drug interactions in clinical practice
AU - Caccia, Silvio
AU - Pasina, Luca
AU - Nobili, Alessandro
PY - 2013/4
Y1 - 2013/4
N2 - Abstract Unexpected drug interactions have led to the withdrawal of many drugs, raising concern about the gap between what is known at the time of approval and the risk of serious effects in the longer term, particularly in high-risk populations generally excluded from drug development. This is because the majority of drug interaction studies are done using in vitro methods, or in healthy young volunteers who may not reflect the complexity of patients, and the settings in which the drug will be used in clinical practice. Pre-marketing interaction studies should therefore be designed to make information easily accessible and clinically transferable. They should be adequate in terms of sample size, population, comorbidity, phenotyping and/or genotyping, end-points and outcome measures, and conducted in conditions of dose, route and timing of co-administration that reproduce the proposed therapeutic indications of the new drug. Although young volunteers have the advantage of minimizing some confounding effects introduced by diseases or polypharmacy, patients drawn from populations for whom the drug is intended would be more relevant and accurate, providing the studies are feasible and safe.
AB - Abstract Unexpected drug interactions have led to the withdrawal of many drugs, raising concern about the gap between what is known at the time of approval and the risk of serious effects in the longer term, particularly in high-risk populations generally excluded from drug development. This is because the majority of drug interaction studies are done using in vitro methods, or in healthy young volunteers who may not reflect the complexity of patients, and the settings in which the drug will be used in clinical practice. Pre-marketing interaction studies should therefore be designed to make information easily accessible and clinically transferable. They should be adequate in terms of sample size, population, comorbidity, phenotyping and/or genotyping, end-points and outcome measures, and conducted in conditions of dose, route and timing of co-administration that reproduce the proposed therapeutic indications of the new drug. Although young volunteers have the advantage of minimizing some confounding effects introduced by diseases or polypharmacy, patients drawn from populations for whom the drug is intended would be more relevant and accurate, providing the studies are feasible and safe.
KW - Clinical practice need
KW - Drug-interactions
KW - Pre-marketing information
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U2 - 10.1016/j.ejim.2012.12.006
DO - 10.1016/j.ejim.2012.12.006
M3 - Article
C2 - 23279878
AN - SCOPUS:84875217006
VL - 24
SP - 217
EP - 221
JO - European Journal of Internal Medicine
JF - European Journal of Internal Medicine
SN - 0953-6205
IS - 3
ER -