AREA UNDER THE CURVE;
ARTICLE;
BIOEQUIVALENCE;
CLINICAL TRIAL;
CONFIDENCE INTERVAL;
DRUG BLOOD LEVEL;
DRUG DOSE REGIMEN;
DRUG EFFICACY;
DRUG INDUSTRY;
DRUG POTENCY;
DRUG SAFETY;
FOOD AND DRUG ADMINISTRATION;
HEALTH PRACTITIONER;
HUMAN;
PRACTICE GUIDELINE;
PUBLIC HEALTH;
ALGORITHM;
BIOAVAILABILITY;
BLOOD;
CHEMISTRY;
COMPARATIVE STUDY;
CROSSOVER PROCEDURE;
DOSE RESPONSE;
DRUG EFFECT;
EPIDEMIOLOGY;
HYPOTHYROIDISM;
METHODOLOGY;
PHARMACEUTICS;
PHARMACOKINETICS;
REVIEW;
SECRETION;
STANDARD;
THYROID GLAND;
UNITED STATES;
ALGORITHMS;
AREA UNDER CURVE;
BIAS (EPIDEMIOLOGY);
BIOLOGICAL AVAILABILITY;
BIOLOGICAL MARKERS;
BIOPHARMACEUTICS;
CHEMISTRY, PHARMACEUTICAL;
CONFOUNDING FACTORS (EPIDEMIOLOGY);
CROSS-OVER STUDIES;
DOSE-RESPONSE RELATIONSHIP, DRUG;
DRUGS, GENERIC;
GUIDELINES;
HUMANS;
HYPOTHYROIDISM;
REFERENCE STANDARDS;
THERAPEUTIC EQUIVALENCY;
THYROID GLAND;
THYROTROPIN;
THYROXINE;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
Food and Drug Administration, Center for Drug Evaluation and Research. Rockville, MD: February
Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing. Rockville, MD: February 2001.
Food and Drug Administration. FDA Advisory Committee for Pharmaceutical Science Briefing Document From Abbott Laboratories. Rockville, MD; May 12-13, 2003. Available at: Accessed March 23
Food and Drug Administration. FDA Advisory Committee for Pharmaceutical Science. Briefing Document From Abbott Laboratories. Rockville, MD; May 12-13, 2003. Available at: http://www.fda.gov/ohrms/dockets/ac/03/briefing/ 3926B1_02_A-Abbot%20.htm. Accessed March 23, 2005.
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6
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Levothyroxine Sodium Tablets
Mylan Laboratories, Inc. Canonsburg, PA: Mylan Laboratories, Inc
FDA Advisory Committee for Pharmaceutical Science. Record of Proceedings
Food and Drug Administration. March 13, 2003. Available at: PharmaceuticalScience. Accessed March 23
Food and Drug Administration. FDA Advisory Committee for Pharmaceutical Science. Record of Proceedings. March 13, 2003. Available at: http://www.fda.gov/ohrms/dockets/ac/cder03.html# PharmaceuticalScience. Accessed March 23, 2005.
(2005)
8
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Citizen's Petition. Abbott Laboratories. August 25, 2003.
Food and Drug Administration. FDA Response to Abbott Petition, Citizen's Petition #2003P-0126/CP1 Document PDN 1. June 29
Food and Drug Administration. FDA Response to Abbott Petition, Citizen's Petition #2003P-0126/CP1, Document PDN 1. June 29, 2004.
(2004)
10
0023867084
Fine adjustment of thyroxine replacement dosage: Comparison of the thyrotrophin releasing hormone test using a sensitive thyrotrophin assay with measurement of free thyroid hormones and clinical assessment
Carr D, McLeod DT, Parry G, Thornes HM. Fine adjustment of thyroxine replacement dosage: comparison of the thyrotrophin releasing hormone test using a sensitive thyrotrophin assay with measurement of free thyroid hormones and clinical assessment. J Clin Endocrinol. 1988;28:325-333.
Food and Drug Administration. Title 21. Available at: Accessed: March 23 CFR 320.33
Food and Drug Administration. Code of Federal Regulations. Title 21, Volume 5: CFR 320.33. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?fr=320.24. Accessed: March 23, 2005.
Health Canada. Expert Advisory Committee on Bioavailability. Record of Proceedings. April 16, 2003. Available at Accessed March 23
Health Canada. Expert Advisory Committee on Bioavailability. Record of Proceedings. April 16, 2003. Available at http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/2003-04-16_e.html. Accessed March 23, 2005.
(2005)
* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.