Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: pharmacokinetics assessment
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The assessment of the pharmacokinetics of BAY 43-9006 (sorafenib) is based on experimental pharmacokinetic studies in rats, mice and dogs as well as on in vitro studies with biological materials of several species including man.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Principles of method if other than guideline:
assessment on pharmacokinetics

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion