Description
A comprehensive knowledge of the absorption, distribution, metabolism and elimination of a compound is important for the interpretation of pharmacology and toxicology studies. Tissue distribution studies are essential in providing information on distribution and accumulation of the compound and/or metabolites, especially in relation to potential sites of action; this information may be useful for designing toxicology and pharmacology studies and for interpreting the results of these experiments.
Scope & Applicability
Product Classes
1Firms implementing ICH guidances
Stakeholders
1Body that endorsed the S10 guidance
Regulatory Context
Attributes
2Condition during chronic maternal dosing for milk sampling
Comparison between tissue/organ half-life and plasma elimination phase
Related CFR Sections (1)
- 21CFR10.90§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.
(a) Regulations. FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both.Read full regulation →
See Also (8)
- General Considerations for the Clinical Evaluation of Drugs (Status: Final)
- Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry (Status: Final)
- Clinical Evaluation of Antiepileptic Drugs (adults and children) (Status: Final)
- Hypnotic Drugs--Clinical Evaluation (Status: Final)
- GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTS (Status: Final)
- E7 Studies in Support of Special Populations: Geriatrics (Status: Final)
- E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Status: Final)
- S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (Status: Final)