Search Results - "Cavagnaro, Joy A."

Preclinical safety evaluation of biotechnology-derived pharmaceuticals by Cavagnaro, Joy A

“…Although the principles of preclinical safety evaluation are similar between conventional pharmaceuticals and biotechnology-derived pharmaceuticals (biotech…”
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Use of Tissue Cross-reactivity Studies in the Development of Antibody-based Biopharmaceuticals: History, Experience, Methodology, and Future Directions by Leach, Michael W., Halpern, Wendy G., Johnson, Carol W., Rojko, Jennifer L., MacLachlan, Tim K., Chan, Curtis M., Galbreath, Elizabeth J., Ndifor, Anthony M., Blanset, Diann L., Polack, Evelyne, Cavagnaro, Joy A.

“…Tissue cross-reactivity (TCR) studies are screening assays recommended for antibody and antibody-like molecules that contain a complementarity-determining…”
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Practical approaches to dose selection for first-in-human clinical trials with novel biopharmaceuticals by Tibbitts, Jay, Cavagnaro, Joy A., Haller, Christine A., Marafino, Ben, Andrews, Paul A., Sullivan, John T.

“…Recent advances in our understanding of disease biology, biomarkers, new therapeutic targets, and innovative modalities have each fueled a dramatic expansion…”
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Not reinventing the wheel: applying the 3Rs concepts to viral vector gene therapy biodistribution studies by MacLachlan, Timothy K, McIntyre, Maritza, Mitrophanous, Kyriacos, Miskin, James, Jolly, Douglas J, Cavagnaro, Joy A

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'Generic' or 'follow-on' biologics: scientific considerations and safety issues by Green, James D, Tsang, Lincoln, Cavagnaro, Joy A

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Outlook: Preclinical safety evaluation of biotechnology-derived pharmaceuticals by Cavagnaro, Joy A

“…Although the principles of preclinical safety evaluation are similar between conventional pharmaceuticals and biotechnology-derived pharmaceuticals (biotech…”
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Regulatory considerations for oligonucleotide drugs: updated recommendations for pharmacology and toxicology studies by Black, L E, Farrelly, J G, Cavagnaro, J A, Ahn, C H, DeGeorge, J J, Taylor, A S, DeFelice, A F, Jordan, A

“…This article describes pharmacology and toxicity studies for oligonucleotide drugs that are recommended for inclusion in the initial Investigational New Drug…”
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Regulatory considerations for evaluating the pharmacology and toxicology of antisense drugs by Black, L E, Degeorge, J J, Cavagnaro, J A, Jordan, A, Ahn, C H

“…This article focuses on pharmacology and toxicology data that should be included in an Investigational New Drug Application (IND), a request to use an…”
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Summaries of round-table discussions

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Immunotoxicity assessment of biotechnology products: a regulatory point of view by Cavagnaro, Joy A.

“…Regulatory points of view have traditionally been thought of as non-committal or reactionary, but rarely visionary. I am going to take this opportunity and try…”
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Design of biological equivalence programs for therapeutic biotechnology products in clinical development : A perspective by MORDENTI, J, CAVAGNARO, J. A, GREEN, J. D

“…The determination of biological equivalence requires that studies are conducted to establish that two molecules, two formulations, of two dosing regimens, for…”
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Progress and challenges in the preclinical assessment of cytokines by Hayes, T J, Cavagnaro, J A

“…This presentation focuses on the history and status of the preclinical toxicologic assessment of recombinant proteins. Cytokines and growth factors are used as…”
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Regulatory concerns in the current practices of clinical pathology by Cavagnaro, J A

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Reproductive toxicity testing of therapeutic biotechnology agents by Henck, Judith W., Hilbish, Kim G., Serabian, Mercedes A., Cavagnaro, Joy A., Hendrickx, Andrew G., Agnish, Narsingh D., Kung, Ada H. C., Mordenti, Joyce

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Toxicologic evaluations of an immunotoxin, H65-RTA by Kung, A H, Cavagnaro, J A, Makin, A, White, M A, Kong, K N

“…A series of acute and multiple dose toxicology studies were performed to support the clinical dose and to evaluate the systemic toxicity of an immunotoxin,…”
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