General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products

U.S. Food and Drug Administration. (2022). General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products.

Type

Report

Intellectual base

Grey literature

Year

2022

Link

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-clinical-pharmacology-considerations-pediatric-studies-drugs-including-biological-products

Cited from

statistics_experimental_design

Cited by

1 citation across 1 artifact.

Each citation links to the sentence it supports in the citing article.

Primes

• Transferability Overclaim
  • In clinical medicine it is the trial conducted in adult males used to dose children or pregnant patients, with the inclusion and exclusion criteria vanished from the prescribing label.

    This sourceFrames extrapolation of adult trial findings to pediatric populations, the conditions under which it is and is not warranted, and the data needed before exporting an adult result to children.

Verification

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Registry ID ref:f6d02f946936 · see in the full table