New levothyroxine formulation meeting 95–105% specification over the whole shelf-life: results from two pharmacokinetic trials

Current Medical Research and Opinion

Volumn 33, Issue 2, 2017, Pages 169-174

  Gottwald Hostalek, Ulrike ^a   Uhl, Wolfgang ^b   Wolna, Peter ^a   Kahaly, George J ^c  

^a MERCK KGAA   (Germany)

^b Former employee of Merck KGa   (Germany)

^c UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

Author keywords

Bioequivalence; dosage form proportionality; levothyroxine; pharmacokinetic trials; specification

Indexed keywords

LEVOTHYROXINE; LEVOTHYROXINE SODIUM; THYROTROPIN; THYROXINE; TABLET;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG DOSE COMPARISON; DRUG FORMULATION; DRUG MARKETING; DRUG POTENCY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FREE LIOTHYRONINE INDEX; FREE THYROXINE INDEX; HEADACHE; HUMAN; HUMAN EXPERIMENT; INCIDENCE; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SHELF LIFE; THYROXINE BLOOD LEVEL; VOMITING; BLOOD; CROSSOVER PROCEDURE; MEDICINAL CHEMISTRY; TABLET; THERAPEUTIC EQUIVALENCE;

ADULT; AREA UNDER CURVE; CHEMISTRY, PHARMACEUTICAL; CROSS-OVER STUDIES; FEMALE; HUMANS; MALE; TABLETS; THERAPEUTIC EQUIVALENCY; THYROXINE;

EID: 84992162475     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1080/03007995.2016.1246434     Document Type: Article

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