Combining radio telemetry and automated blood sampling: A novel approach for integrative pharmacology and toxicology studies

Journal of Pharmacological and Toxicological Methods

Volumn 62, Issue 1, 2010, Pages 30-39

  Kamendi, Harriet W ^a   Brott, David A ^a   Chen, Yafei ^a   Litwin, Dennis C ^a   Lengel, David J ^a   Fonck, Carlos ^a   Bui, Khanh H ^a   Gorko, Mary Ann ^a   Bialecki, Russell A ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

Automated blood sampling; Cardiovascular; Electroencephalogram; Integrative; Pharmacodynamic; Pharmacokinetic; Pharmacology; Radio telemetry; Renal; Safety pharmacology; Stress; Toxicology

Indexed keywords

BACLOFEN; SODIUM CHLORIDE; STRESS HORMONE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; AUTOMATION; BLOOD PRESSURE; BLOOD SAMPLING; BODY TEMPERATURE; BODY WEIGHT; CARDIOVASCULAR EFFECT; CARDIOVASCULAR RESPONSE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; ELECTROENCEPHALOGRAM; FEASIBILITY STUDY; HEART RATE; HYPERTENSION; KIDNEY FUNCTION; MAXIMUM PLASMA CONCENTRATION; MEAN ARTERIAL PRESSURE; NONHUMAN; PHARMACODYNAMICS; RAT; TELEMETRY; WEIGHT REDUCTION;

ANIMALS; AUTOMATION; BACLOFEN; BLOOD PRESSURE; BLOOD SPECIMEN COLLECTION; BODY TEMPERATURE; ELECTRODES, IMPLANTED; ELECTROENCEPHALOGRAPHY; FEMALE; HEART RATE; HORMONES; KIDNEY; MALE; MUSCLE RELAXANTS, CENTRAL; RATS; RATS, WISTAR; TELEMETRY; URINE;

ANIMALIA; RATTUS;

EID: 77956174942     PISSN: 10568719     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vascn.2010.04.014     Document Type: Article

References (21)

1. Anon Guidance for industry: Safety studies for biotechnological products. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) 1997.
2. Anon Guidance for industry: Safety pharmacology studies for human pharmaceuticals. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) 2001.
3. Anon Final report on the pilot joint EMEA/FDA VXDS experience on qualification of nephrotoxicity biomarkers. European Medicines Agency. Pre-authorization evaluation of medicines for human use. Committee for Human Medicinal Products 2008.
4. Anon Guidance for industry: Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) 2009.
5. Balcombe J.P., Barnard N.D., Sandusky C. Laboratory routines cause animal stress. Contemporary Topics in Laboratory Animal Science 2004, 43:42-51.
6. Capdevila S., Giral M., Ruiz de la Torre J.L., Russell R.J., Kramer K. Acclimatization of rats after ground transportation to a new animal facility. Laboratory Animals 2007, 41:255-261.
7. Chahl L.A., Walker S.B. The effect of baclofen on the cardiovascular system of the rat. British Journal of Pharmacology 1980, 69:631-637.
8. Damon E.G., Eidson A.F., Hobbs C.H., Hahn F.F. Effect of acclimation to caging on nephrotoxic response of rats to uranium. Laboratory Animal Science 1986, 36(1):24-27.
9. Gartner K., Buttner D., Dohler K., Friedel R., Lindena J., Trautschold I. Stress response of rats to handling and experimental procedures. Laboratory Animals 1980, 14:267-274.
10. Institute of Laboratory Animal Research (ILAR) Commission on Life Sciences, National Research Council. Guide for the care and use of laboratory animals 1996, National Academy Press, Washington DC.
11. Litwin, D. C., Lengel, D. J., Kamendi, H. W., Bialecki, R. A. An integrative pharmacological approach to radiotelemetry and blood sampling in pharmaceutical drug discovery and safety assessment. IEEE Engineering in Medicine and Biology Society (in press).
12. Loeb, W. F. and Quimby, F. W. (1999). The clinical chemistry of laboratory animals (2nd edition). Taylor and Francis, Philadelphia, PA.
13. Matamoros R.A., Levine B.S. Stress response and drug metabolism in mice. Fundamental and Applied Toxicology 1996, 30:255-263.
14. Persson B., Henning M. Cardiovascular effects of baclofen in the rat. Journal of Pharmacy and Pharmacology 1979, 31:799-800.
15. Seggie J.A., Brown G.M. Stress response patterns of plasma corticosterone, prolactin, and growth hormone in the rat, following handling or exposure to novel environment. Canadian Journal of Physiology and Pharmacology 1975, 53:629-637.
16. Sharp J.L., Zammit T.G., Azar T.A., Lawson D.M. Stress-like responses to common procedures in male rats housed alone or with other rats. Contemporary Topics in Laboratory Animal Science 2002, 41:8-14.
17. Steinfels G.F., Young G.A., Khazan N. Diurnal variations in REM and NREM sleep EEG power spectra in the rat. Brain Research 1980, 181(2):425-432.
18. Sun J., Schnackenberg L.K., Beger R.D. Studies of acetaminophen and metabolites in urine and their correlations with toxicity using metabolomics. Drug Metabolism Letters 2009, 3:130-136.
19. Swallow J., Anderson D., Buckwell A.C., Harris T., Hawkins P., Kirkwood J., Lomas M., Meacham S., Peters A., Prescott M., Owen S., Quest R., Sutcliffe R., Thompson K. Guidance on the transport of laboratory animals. Laboratory Animals 2005, 39:1-39.
20. Vahl T.P., Ulrich-Lai Y.M., Ostrander M.M., Dolgas C.M., Elfers E.E., Seeley R.J., D'Alessio D.A., Herman J.P. Comparative analysis of ACTH and corticosterone sampling methods in rats. American Journal of Physiology. Endocrinology Metabolism 2005, 289:E823-E828.
21. van Ruiven R., Meijer G., Wiersma A., Baumans V., van Zutphen L., Ritskes-Hoitinga J. The influence of transportation stress on selected nutritional parameters to establish the necessary minimum period for adaptation in rat feeding studies. Laboratory Animals 1998, 32:446-456.