In vitro methods for evaluating the in vivo effectiveness...

Details In vitro methods for evaluating the in vivo effectiveness... In vitro methods for evaluating the in vivo effectiveness...

2007-04-03

2007-04-03

Richter, Johann (Department: 1616)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

C424S464000, C424S489000, C424S455000, C424S451000, C424S466000

Reexamination Certificate

active

10323736

ABSTRACT:
Disclosed are in vitro methods for evaluating the in vivo redispersibility of dosage forms of poorly water-soluble active agents. The methods utilize media representative of in vivo human physiological conditions.

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Guidance for Industry, Levothyroxine sodium Tablets-In vivo pharmacokinetic and Bioavailability Studies and in vitro dissolution testing, U.S. Department of Health and Human Services, Food and Drug administration, Dec. 2000.

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