Use in Specific Populations (§ 201.57(a)(13))
Information under the Use in Specific Populations heading includes a concise summary
of any clinically important differences in response or recommendations for use of the
drug in specific populations (e.g., differences between adult and pediatric responses, need
for specific monitoring in patients with hepatic impairment, need for dosing adjustments
in patients with renal impairment). Typically, information under this heading includes
limitations or precautions for specific populations or established differences in response.
Absence of the clinical study data in pediatric and geriatric population could sometimes cause problems in product label or in the drug approval process. During the drug development process, it is prudent to consider the inclusion/exclusion of patient population in terms of the age limit. In the study protocol, the inclusion criteria pertinent to the age limits (upper and lower limits) should be carefully considered. In the statistical analysis, when data for pediatric and/or geriatric population is available, subgroup analysis should always be performed.
In regulatory environment, the classification of the pediatric and geriatric population are defined as:
Pediatric population: according to ICH guidance E11 "Clinical Investigation of Medicinal Products in the Pediatric Population", the pediatric population contains several sub-cateogires:
- preterm newborn infants
- term newborn infants (0 to 27 days)
- infants and toddlers (28 days to 23 months)
- children (2 to 11 years)
- adolescents (12 to 16-18 years (dependent on region))
for Drugs and Biological Products", the age classification is a little bit different. I am assuming that the ICH guidance E11 should be the correct reference.
Geriatric population is defined as persons 65 years of age and older. There is no upper limit of age defined. The Food and Drug Administration has regulations governing the content and format of labelling for human prescription drug products, including biological products, to include information pertinent to the appropriate use of drugs in the elderly and to facilitate access to this information by establishing a “Geriatric use” subsection in the labelling.
- Regulatory requirements for the development of medicinal products for pediatric use by Dr. Tom Sam
- FDA good review process "Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information"
- FDA's Pediatric Drug Development
- Pediatric Trials: a Worldview