Description
It is important to ensure that clinical testing programs are carried out according to harmonized guidelines based on agreed ethical and scientific principles so that the international development of valuable innovative drugs is achieved with maximum efficiency. Harmonization in relation to medicines for geriatric populations is an important issue because the total population of the elderly will increase significantly in the coming years in Europe, Japan and the USA. The use of drugs in this population requires special consideration due to the frequent occurrence of underlying diseases, concomitant drug therapy and the consequent risk of drug interaction.
Scope & Applicability
Product Classes
3Separate studies recommended for psychoactive drugs with important CNS effects
development program for drug and biological products
Scope of the guidance
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
1initial PK study can be a pilot trial conducted under steady-state conditions
Identified Hazards
Hazards
1Risk associated with concomitant drug therapy in the elderly
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)
- E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Status: Final)
- S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (Status: Final)
- S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (Status: Final)