Pharmacokinetic equivalence of a levothyroxine sodium soft capsule manufactured using the new Food and Drug Administration potency guidelines in healthy volunteers under fasting conditions

Therapeutic Drug Monitoring

Volumn 33, Issue 3, 2011, Pages 355-361

  Colucci, Philippe ^a,b   D'Angelo, Pina ^b   Mautone, Giuseppe ^c   Scarsi, Claudia ^c   Ducharme, Murray P ^a,b  

^a UNIVERSITÉ DE MONTRÉAL   (Canada)

^b Cetero Research   (United States)

^c Institut Biochimique SA   (Switzerland)

Author keywords

FDA; Levothyroxine; Pharmacokinetic equivalence; Proportionality; Tirosint

Indexed keywords

LEVOTHYROXINE SODIUM;

ABDOMINAL PAIN; ADULT; AREA UNDER THE CURVE; ARTICLE; ATRIOVENTRICULAR BLOCK; BACKACHE; BIOEQUIVALENCE; BLOOD PRESSURE; BODY TEMPERATURE; BRADYCARDIA; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIET RESTRICTION; DIZZINESS; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG CAPSULE; DRUG FORMULATION; DRUG HALF LIFE; DRUG MANUFACTURE; DRUG POTENCY; DRUG TOLERABILITY; FATIGUE; FEMALE; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEART PALPITATION; HEART RATE; HUMAN; HUMAN EXPERIMENT; JITTERY; MALE; MAXIMUM PLASMA CONCENTRATION; MYALGIA; NAUSEA; NORMAL HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINUS BRADYCARDIA; SYSTOLIC BLOOD PRESSURE; TABLET FORMULATION; THORAX PAIN; TIME TO MAXIMUM PLASMA CONCENTRATION; VAGINA BLEEDING; VOLUNTEER;

ADULT; CAPSULES; CHEMISTRY, PHARMACEUTICAL; CROSS-OVER STUDIES; DOSAGE FORMS; FASTING; FEMALE; HUMANS; MALE; TABLETS; THERAPEUTIC EQUIVALENCY; THYROXINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80051801908     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e318217b69f     Document Type: Article

References (15)

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