Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2guidelines for the clinical evaluation of Antiepileptic Drugs (Adults and Children); The specific class of drugs covered by these clinical evaluation guidelines.; Subject of the clinical evaluation guidance.
Guidelines present acceptable current approaches to the study of investigational drugs in man.; Drugs undergoing clinical trials in man.
Stakeholders
4Comments on the contents of this publication should be addressed to this role.
Assisted the FDA in developing guidelines.
Specific processes found on the GRP website
Recommended for formulation of study design and sample size.
Regulatory Context
Regulatory Activities
6Cancer clinical trials involving dose escalation
Advanced stage of environmental impact assessment for higher risk products
pertain to Phases I through III of the investigation; Extended trials to confirm efficacy and safety in heterogeneous populations; Clinical testing phases for hypnotic drugs.
Early clinical trials focused on safety evaluations of new compounds.
Clinical trials involving patients with incomplete control of seizure disorders.; Studies to demonstrate relative safety and efficacy before extension.
Large scale trials involving ambulatory and institutionalized patients.
Document Types
1Rigidity varies between Phase I, II, and III.
Attributes
3evaluating pubertal development for evaluation of safety
alternative would better ensure the effectiveness of the device
Evidence required during Phase I to show the drug is available at the administered dosage.
Technical Details
Substances
1Commonly used anesthetic class
Testing Methods
7Adjunctive neurological assessment; Neurophysiologic testing for safety signals
Additional ECG assessment for drugs with large QTc prolongation effects
Methods used to present evidence of biological availability during Phase I.
Suggested if prior studies indicate emotional factors may be affected.
Highly recommended for pretest and test drugs to observe interactions.
Usual safety laboratory tests including platelet estimation.
Used to quantify systemic exposure
Processes
1Possibility when investigational drug is given with barbiturates.
Clinical Concepts
6The primary medical condition addressed by the antiepileptic drug therapy.
Subject population requiring additional safeguards in research
Target population for the prevention of PONV in this guidance.
An acute seizure situation that may require modification of the guidelines.; Adequate safety precautions must be taken to prevent and treat this.
A specific seizure type also referred to as grand mal seizures.
Seizure type restricted to the young-age period.
Standards & References
External Standards
1The standard used for the classification of seizures in patient selection.; Used for classification of seizure types in trials.
Specifications
1Documented levels of standard therapy used to select suitable subjects.
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 →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
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)
- 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)
- S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (Status: Final)
- S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (Status: Final)