Search Results - "Derzi, Mazin"

Microphysiological systems in early stage drug development: Perspectives on current applications and future impact by Kopec, Anna K., Yokokawa, Ryuji, Khan, Nasir, Horii, Ikuo, Finley, James E., Bono, Christine P., Donovan, Carol, Roy, Jessica, Harney, Julie, Burdick, Andrew D., Jessen, Bart, Lu, Shuyan, Collinge, Mark, Sadeghian, Ramin Banan, Derzi, Mazin, Tomlinson, Lindsay, Burkhardt, John E.

“…Microphysiological systems (MPS) are making advances to provide more standardized and predictive physiologically relevant responses to test articles in living…”
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Industry Perspective on Biomarker Development and Qualification by Gerlach, Cory V., Derzi, Mazin, Ramaiah, Shashi K., Vaidya, Vishal S.

“…Pharmaceutical and biotechnology companies routinely use biomarkers to obtain quantitative metrics for drug exposure, efficacy, and safety and to inform…”
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FcγR3A genotype influences the inhibition of activated T cell proliferation by infliximab and adalimumab (HUM1P.313) by Casinghino, Sandra, Cole, Susan, Bono, Christine, Al-Derzi, Mazin

“…Abstract The anti-tumor necrosis factor (TNF) antibodies, infliximab and adalimumab are efficacious in Crohn’s disease (CD) patients but their relevant…”
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Evaluation of Therapeutics for Severely Debilitating or Life‐Threatening Diseases or Conditions: Defining Scope to Enable Global Guidance Development by Liu, Maggie, Fields, F. Owen, Prescott, Judith S., Bello, Akintunde, Bower, Nancy, Darakjy, Salima, Hartke, James, Kadambi, Vivek, Lapadula, Daniel, Stoch, Aubrey, Derzi, Mazin

“…A significant regulatory gap exists to facilitate global development of therapeutics for nononcology severely debilitating or life‐threatening diseases or…”
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Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective by Butler, Lynne D., Guzzie-Peck, Peggy, Hartke, James, Bogdanffy, Matthew S., Will, Yvonne, Diaz, Dolores, Mortimer-Cassen, Elisabeth, Derzi, Mazin, Greene, Nigel, DeGeorge, Joseph J.

“…The transition from nonclinical to First-in-Human (FIH) testing is one of the most challenging steps in drug development. In response to serious outcomes in a…”
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Comparative nonclinical assessments of the biosimilar PF-06410293 and originator adalimumab by Derzi, Mazin, Shoieb, Ahmed M., Ripp, Sharon L., Finch, Gregory L., Lorello, Leslie G., O'Neil, Shawn P., Radi, Zaher, Syed, Jameel, Thompson, Matthew S., Leach, Michael W.

“…Adalimumab, a recombinant fully human monoclonal antibody targeting tumor necrosis factor (TNF), is approved in the United States and Europe to treat various…”
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An Industry Perspective on the 2017 EMA Guideline on First‐in‐Human and Early Clinical Trials by DeGeorge, Joseph, Robertson, Sarah, Butler, Lynne, Derzi, Mazin, Stoch, S. Aubrey, Diaz, Dolores, Hartke, James, Guzzie‐Peck, Peggy, Mortimer‐Cassen, Elisabeth, Bogdanffy, Matthew, Will, Yvonne, Greene, Nigel

“…The European Medicines Agency (EMA) in 2017 issued a revised guideline on nonclinical and clinical aspects of first‐in‐human (FIH) and early clinical trials…”
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Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade® (Infliximab) by Derzi, Mazin, Johnson, Theodore R., Shoieb, Ahmed M., Conlon, Hugh D., Sharpe, Penny, Saati, Andrew, Koob, Sarah, Bolt, Michael W., Lorello, Leslie G., McNally, Jim, Kirchhoff, Carol F., Smolarek, Teresa A., Leach, Michael W.

“…Introduction PF-06438179, a potential biosimilar to Remicade ® (infliximab, Janssen Biotech, Inc.), is a chimeric mouse–human monoclonal antibody targeting…”
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An overview of the preclinical toxicity and potential carcinogenicity of sitaxentan (Thelin®), a potent endothelin receptor antagonist developed for pulmonary arterial hypertension by Owen, Keith, Cross, David M., Derzi, Mazin, Horsley, Elizabeth, Stavros, Fiona L.

“…► Sitaxentan preclinical safety was assessed in mice, rats, and dogs. ► Coagulopathy, increased serum alkaline phosphatase, hepatic hypertrophy and decreased…”
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Mo1221 Comparative Assessments of PF-06438179, a Potential Biosimilar, and Infliximab in a Phase 1 Pharmacokinetic Study by Yin, Donghua, Udata, Chandrasekhar, Hua, Steven, Salts, Stephanie, Meng, Xu, Johnson, Theodore R, Derzi, Mazin, Conlon, Hugh, Kirchhoff, Carol, Rehman, Muhammad

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Corrigendum to ‘‘An overview of the preclinical toxicity and potential carcinogenicity of sitaxentan (Thelin®), a potent endothelin receptor antagonist developed for pulmonary arterial hypertension” [Regul. Toxicol. Pharmacol. 2012, 95–103] by Owen, Keith, Cross, David M., Derzi, Mazin, Horsley, Elizabeth, Stavros, Fiona L.

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Evaluation of sitaxentan (Thelin®) toxicity in juvenile rats and regulatory interactions during the development of a European Medicines Agency pediatric investigation plan by Cross, David M., Derzi, Mazin, Horsley, Elizabeth, Owen, Keith, Stavros, Fiona L.

“…► Sitaxentan toxicity was assessed in juvenile rats. ► Using multiple endpoints, there were no safety concerns specific to juvenile rats. ► Changes identified…”
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An Evaluation of Reproductive and Developmental Toxicity of Sitaxentan (Thelin) in Rats by Cross, David M., Horsley, Elizabeth, Derzi, Mazin, Owen, Keith, Stavros, Fiona L.

“…Sitaxentan sodium (Thelin) is a once daily, orally bioavailable, highly selective endothelin A receptor antagonist. Initially approved for the treatment of…”
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