Regulatory demands on data quality for the environmental risk assessment of pharmaceuticals.
The evaluation of the quality of data and their use within the review of environmental risk assessment of human as well as veterinary pharmaceuticals is described from a regulatory point of view. A definition and differentiation in three categories for the reliability of data are given. Existing criteria relating to international testing standards for categorising reliability are adopted for their use within the environmental risk assessment of pharmaceuticals. A systematic documentation of evaluating reliability for literature data as well as for experimental studies (effect and environmental fate studies) is proposed. The data quality criteria are defined in order to increase the transparency of the evaluation process in Germany and thus the quality of the environmental risk assessment of pharmaceuticals.
Küster
A
A
Federal Environment Agency, Pharmaceuticals, Washing and Cleansing Agents, Wörlitzer Platz 1, 06813 Dessau, Germany. anette.kuester@uba.de
Bachmann
J
J
Brandt
U
U
Ebert
I
I
Hickmann
S
S
Klein-Goedicke
J
J
Maack
G
G
Schmitz
S
S
Thumm
E
E
Rechenberg
B
B
D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions; D004781:Environmental Exposure / Q000009:adverse effects / Q000331:legislation & jurisprudence*; D004784:Environmental Monitoring / Q000331:legislation & jurisprudence* / Q000379:methods; D005858:Germany; D017408:Guidelines as Topic; D006801:Humans; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods; D019155:Veterinary Drugs / Q000633:toxicity*
D019155:Veterinary Drugs