Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing
This guidance is intended to assist sponsors of new drug applications (NDAs) for levothyroxine sodium tablets who wish to conduct in vivo pharmacokinetic and bioavailability studies and in vitro dissolution testing for their products. Information from these studies would generally be submitted in section 6 of an NDA. Sponsors who wish to use approaches other than those recommended in this guidance should discuss their plans with the FDA prior to preparing an NDA.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.