Comparative pharmacokinetic profiles of a novel isotretinoin formulation (isotretinoin-Lidose) and the innovator isotretinoin formulation: A randomized, 4-treatment, crossover study

Journal of the American Academy of Dermatology

Volumn 69, Issue 5, 2013, Pages 762-767

  Webster, Guy F ^a   Leyden, James J ^b   Gross, Jason A ^c  

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c Cipher Pharmaceutical Inc   (Canada)

Author keywords

acne; area under the curve; bioavailability; fasting; fed; isotretinoin; maximum measured plasma concentration over sampling time period; systemic exposure; time of maximum measured plasma concentration

Indexed keywords

ABSORICA; ISOTRETINOIN; UNCLASSIFIED DRUG;

ADULT; ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG INDUCED HEADACHE; FEMALE; HUMAN; LIPID DIET; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE;

ACNE; AREA UNDER PLASMA CONCENTRATION VERSUS TIME CURVE FROM TIME ZERO (0 HOUR) TO TIME OF LAST MEASURABLE PLASMA CONCENTRATION, CALCULATED BY LINEAR TRAPEZOIDAL METHOD; AREA UNDER PLASMA CONCENTRATION VERUS TIME CURVE FROM TIME ZERO (0 HOUR) TO INFINITY (AUCI CALCULATED AS SUM OF AUCT + MEASURED PLASMA CONCENTRATION AT TIME OF LAST MEASURABLE PLASMA CONCENTRATION/APPARENT FIRST ORDER ELIMINATION RATE CONSTANT); AREA UNDER THE CURVE; AUCI; AUCT; BA; BE; BIOAVAILABILITY; BIOEQUIVALENT; CMAX; FASTING; FDA; FED; FOOD AND DRUG ADMINISTRATION; ISOTRETINOIN; MAXIMUM MEASURED PLASMA CONCENTRATION OVER SAMPLING TIME PERIOD; SYSTEMIC EXPOSURE; TIME OF MAXIMUM MEASURED PLASMA CONCENTRATION; TMAX;

ADULT; CROSS-OVER STUDIES; DERMATOLOGIC AGENTS; FEMALE; HUMANS; ISOTRETINOIN; MALE; MIDDLE AGED; PHARMACEUTICAL PREPARATIONS; SINGLE-BLIND METHOD; YOUNG ADULT;

EID: 84885632505     PISSN: 01909622     EISSN: 10976787     Source Type: Journal    
DOI: 10.1016/j.jaad.2013.05.036     Document Type: Article

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