Search Results - "Leighton, J K"

Qualification of cardiac troponins for nonclinical use: A regulatory perspective by Hausner, E.A., Hicks, K.A., Leighton, J.K., Szarfman, A., Thompson, A.M., Harlow, P.

“…•Discussion of first successful use of published research for biomarker qualification.•The cardiac troponins submission and proposed context of use are…”
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Fasting decreases apolipoprotein B mRNA editing and the secretion of small molecular weight apoB by rat hepatocytes: evidence that the total amount of apoB secreted is regulated post-transcriptionally by Leighton, J K, Joyner, J, Zamarripa, J, Deines, M, Davis, R A

“…Two different molecular weight forms of apoB are produced from a common initial transcript via editing of a Gln codon (CAA) to a stop codon (UAA), leading to a…”
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Steroidogenic cytochrome P450 enzyme messenger ribonucleic acids and follicular fluid steroids in individual follicles during preovulatory maturation in the pig by Guthrie, H.D. (USDA, ARS, Beltsville Agricultural Research Center, Beltsville, MD.), Barber, J.A, Leighton, J.K, Hammond, J.M

“…Changes in follicular concentrations of steroidogenic cytochrome P450 enzyme mRNAs were determined during preovulatory maturation. RNA was isolated from 59…”
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Center for Veterinary Medicine's perspective on the beef hormone case by Leighton, J K

“…Steroidal sex hormones and synthetic derivatives are used in the US to enhance growth in food-producing animals. The European Economic Community has banned use…”
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Nonclinical Aspects of Biopharmaceutical Development: Discussion of Case Studies at a PhRMA-FDA Workshop by Buckley, L. A., Benson, K., Davis-Bruno, K., Dempster, M., Finch, G. L., Harlow, P., Haggerty, H.G., Hart, T., Kinter, L., Leighton, J. K., McNulty, J., Roskos, L., Saber, H., Stauber, A., Tabrizi, M.

“…Robust assessments of the nonclinical safety profile of biopharmaceuticals are best developed on a scientifically justified, case-by-case basis, with…”
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Activation of the silent endogenous cholesterol-7-alpha-hydroxylase gene in rat hepatoma cells: a new complementation group having resistance to 25-hydroxycholesterol by LEIGHTON, J. K, DUELAND, S, STRAKA, M. S, TRAWICK, J, DAVIS, R. A

“…Article Usage Stats Services MCB Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley…”
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Nucleotide sequence of the rat low density lipoprotein receptor cDNA by LEE, L. Y, MOHLER, W. A, TANAKA, R. D, SCHAFER, B. L, FREUDENBERGER, J. S, BYRNE-CONNOLLY, N, EAGER, K. B, MOSLEY, S. T, LEIGHTON, J. K, THRIFT, R. N, DAVIS, R. A

“…A 4.7 kb cDNA clone ( lambda rLDL2-1a) coding for the rat low density lipoprotein (LDL) receptor was isolated from a lambda gt-11 rat liver cDNA library. The…”
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Differential induction and tissue-specific expression of closely related members of the phenobarbital-inducible rabbit cytochrome P-450 gene family by Leighton, J K, Kemper, B

“…We have examined the tissue-specific expression of three rabbit genes that are closely related members of a subfamily of the phenobarbital-inducible cytochrome…”
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Increased Translatable mRNA and Decreased Lipogenesis Are Responsible for the Augmented Secretion of Lipid-deficient Apolipoprotein E by Hepatocytes from Fasted Rats by Davis, R A, Dluz, S M, Leighton, J K, Brengaze, V A

“…We examined the mechanism through which fasting selectively increases the secretion of apoE while it decreases the secretion of all lipoprotein lipids (Davis,…”
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Expression of cytochrome P450 1A1, an estrogen hydroxylase, in ovarian granulosa cells is developmentally regulated by Leighton, John K., Canning, Sandra, Guthrie, H.D., Hammond, James M.

“…In this paper we report the analysis of porcine ovarian granulosa cells for the expression of several known hepatic estrogen hydroxylase RNAs. Of the P450s…”
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Expression of the IGF system in primary and immortalized porcine ovarian granulosa cells by Leighton, J K, Grimes, R W, Canning, S, Hammond, J M

“…We have established a novel granulosa cell line derived from porcine ovarian follicles (4-6 mm in diameter). This cell line, MDG2.1, was obtained by…”
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An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection by Saber, Haleh, Del Valle, Pedro, Ricks, Tiffany K., Leighton, John K.

“…We retrospectively examined the nonclinical studies conducted with 17 CD3 bispecific constructs in support of first-in-human (FIH) trials in oncology. We also…”
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Steroidogenic Cytochrome P450 Enzyme Messenger Ribonucleic Acids and Follicular Fluid Steroids in Individual Follicles during Preovulatory Maturation in the Pig1 by Guthrie, H. D., Barber, J. A., Leighton, J. K., Hammond, J. M.

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An FDA oncology analysis of immune activating products and first-in-human dose selection by Saber, Haleh, Gudi, Ramadevi, Manning, Michael, Wearne, Emily, Leighton, John K.

“…As sub-therapeutic doses are not medically justifiable in patients with cancer, we retrospectively analyzed data on immune activating products, to assess…”
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IGF-binding proteins are differentially regulated in an ovarian granulosa cell line by Leighton, J K, Grimes, R W, Canning, S F, Hammond, J M

“…We have recently established an immortalized granulosa cell line as a model system to investigate ovarian function, with particular emphasis on the…”
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Isolation and sequence analysis of three cloned cDNAs for rabbit liver proteins that are related to rabbit cytochrome P-450 (form 2), the major phenobarbital-inducible form by Leighton, John K, DeBrunner-Vossbrinck, Bettina A, Kemper, Byron

“…We have isolated from rabbit liver three cDNA clones of 1400-1800 base pairs that hybridize selectively to RNA from animals treated with phenobarbital. The…”
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Characterization of rabbit cytochrome P450IIC4 cDNA and induction by phenobarbital of related hepatic mRNA levels by Zhao, J, Leighton, J K, Kemper, B

“…We have cloned cDNA containing a partial sequence of a rabbit cytochrome P-450 (designated cytochrome P450IIC4) cDNA that is a member of the cytochrome P450IIC…”
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Approval Summary: Azacitidine for Treatment of Myelodysplastic Syndrome Subtypes by KAMINSKAS, Edvardas, FARRELL, Ann, WANG, Yong-Cheng, PAZDUR, Richard, ABRAHAM, Sophia, BAIRD, Amy, HSIEH, Li-Shan, LEE, Shwu-Luan, LEIGHTON, John K, PATEL, Hasmukh, RAHMAN, Atiqur, SRIDHARA, Rajeshwara

“…Purpose: This article summarizes data submitted to the U.S. Food and Drug Administration for marketing approval of azacitidine as injectable suspension…”
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Application of Emerging Technologies in Toxicology and Safety Assessment: Regulatory Perspectives by Leighton, John K.

“…Emerging technologies applied in the regulatory field encompass a group of technologies that are used in addition to or in replacement of the standard…”
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Pharmacogenomic data submissions to the FDA: non-clinical case studies by Leighton, John K, DeGeorge, Joseph, Jacobson-Kram, David, MacGregor, James, Mendrick, Donna, Worobec, Alexandra

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