FDA: Hydrocortisone [Regulatives / Guidelines]

posted by Mahesh M – India, 2015-09-15 10:03 (3438 d 20:59 ago) – Posting: # 15397
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In draft guidance of Hydrocortisone mentioned “A 4 mg dose of dexamethasone should be administered 10 hours prior to drug administration as a pre-treatment to lower endogenous hydrocortisone levels.“ But in guidance not mentioned regarding base line correction or pre dose samples.

Is it required to take pre dose samples for base line correction of hydrocortisone?

Please share your thoughts on it.
Thanks and regards
Mahesh


Edit: Subject line changed and guidance linked. [Helmut]

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