Bioequivalence studies for three formulations of a recombinant human growth hormone: Challenges and lessons learned

Growth Hormone and IGF Research

Volumn 20, Issue 5, 2010, Pages 367-371

  Dao, Le ^a   Jacobs, Joan ^a   Kuebler, Peter ^a   Bakker, Bert ^a   Lippe, Barbara ^a  

^a GENENTECH INC   (United States)

Author keywords

Bioequivalence; Human growth hormone; Nutropin AQ; Pharmacokinetics; RhGH

Indexed keywords

HUMAN GROWTH HORMONE;

ADULT; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM COMPARISON; DRUG FATALITY; DRUG FORMULATION; DRUG HALF LIFE; DRUG WITHDRAWAL; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; METHODOLOGY; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REFERENCE VALUE; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; VITAL SIGN;

ADOLESCENT; ADULT; BIOLOGICAL AVAILABILITY; HUMAN GROWTH HORMONE; HUMANS; MALE; MIDDLE AGED; RECOMBINANT PROTEINS; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 77957122123     PISSN: 10966374     EISSN: 15322238     Source Type: Journal    
DOI: 10.1016/j.ghir.2010.07.002     Document Type: Article

References (9)

1. Wilson T.A., Rose S.R., Cohen P., et al. Update of guidelines for the use of growth hormone in children: the Lawson Wilkins Drug and Therapeutics Committee. J Pediatr. 2003, 143:415-421.
2. Molitch M.E., Clemmons D.R., Malozowski S., Merriam G.R., Shalet S.M., Vance M.L. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society Clinical Practice Guideline. J. Clin. Endocrinol. Metab. 2006, 91:1621-1634.
3. Jacobsen L.V., Roland P., Christensen M.S., Knudsen K.M. Bioequivalence between ready-to-use recombinant human growth hormone (rhGH) in liquid formulation and rhGH for reconstitution. Growth Horm. IGF Res. 2000, 10:93-98.
4. Laursen T., Susgaard S., Jensen F.S., Jorgensen J.O.L., Christiansen J.S. Absorption kinetics of two highly concentrated preparations of growth hormone: 12IU/mL compared to 56IU/mL. Pharmacol. Toxicol. 1994, 74:54-57.
5. Guidance for Industry: Statistical Approaches to Establishing Bioequivalence January 2001, U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf.
6. Jorgensen J.O.L. Human growth hormone therapy: pharmacological and clinical aspects. Endocr. Rev. 1991, 12:189-207.
7. Laursen T. Clinical pharmacological aspects of growth hormone administration [review]. Growth Horm. IGF Res. 2004, 14:16-44.
8. Strauss K., Hannet I., McGonigle J., et al. Ultrashort (5mm) insulin needles: trial results and clinical recommendations. Pract Diabetes Int. 1999, 16:218-221.
9. Tubiana-Rufi N., Belarbi N., Du Pasquier-Fediaevsky L., et al. Short needles (8mm) reduce the risk of intramuscular injections in children with type 1 diabetes. Diab. Care 1999, 22:1621-1625.