Immunogenicity and Immune Complex Disease in Preclinical Safety Studies von Vahle, John L.

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Inspiration and Exasperation: The Challenges of Inhaled Biologics von Hall, Peter, Vahle, John L., Colman, Karyn

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Role of Anatomic Pathology in Skeletal Evaluations: Applying INHAND Diagnostic Criteria von Vahle, John L.

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The Dog as a Second Species for Toxicology Testing Provides Value to Drug Development von Bower, Nancy, Achanzar, William E., Boulifard, Virginie, Brinck, Peter R., Kittel, Birgit, Vahle, John L.

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Bone Neoplasms in F344 Rats Given Teriparatide [rhPTH(1-34)] Are Dependent on Duration of Treatment and Dose von Vahle, John L., Long, Gerald G., Sandusky, George, Westmore, Michael, Ma, Yanfei Linda, Sato, Masahiko

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Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxic... von McDorman, Kevin S., Bennet, Bindu M., Colman, Karyn, Fikes, James D., Keirstead, Natalie D., Lanning (retired), Lynda, Munch, Barbara, Romeike, Annette, Schafer, Kenneth A., Schorsch, Frédéric, Thibodeau, Michael S., Thomas, Heath C., Troth, Sean, Vahle, John L., Geoly, Frank J.

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ICH S1 prospective evaluation study and weight of evidence assessments: commentary from industry representatives von Vahle, John L, Dybowski, Joe, Graziano, Michael, Hisada, Shigeru, Lebron, Jose, Nolte, Thomas, Steigerwalt, Ronald, Tsubota, Kenjiro, Sistare, Frank D

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Skeletal Changes in Rats Given Daily Subcutaneous Injections of Recombinant Human Parathyroid Hormone (1-34) for 2 Years and Relevance to Human Safety von Vahle, John L., Sato, Masahiko, Long, Gerald G., Young, Jamie K., Francis, Paul C., Engelhardt, Jeffery A., Westmore, Michael S., Ma, Yanfei Linda, Nold, James B.

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Use of toxicogenomics in drug safety evaluation: Current status and an industry perspective von Vahle, John L., Anderson, Ulf, Blomme, Eric A.G., Hoflack, Jean-Christophe, Stiehl, Daniel P.

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Chronic Toxicity and Carcinogenicity Studies of the Long-Acting GLP-1 Receptor Agonist Dulaglutide in Rodents von Byrd, Richard A, Sorden, Steven D, Ryan, Thomas, Pienkowski, Thomas, LaRock, Richard, Quander, Ricardo, Wijsman, John A, Smith, Holly W, Blackbourne, Jamie L, Rosol, Thomas J, Long, Gerald G, Martin, Jennifer A, Vahle, John L

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Pancreatic Effects of a Bruton’s Tyrosine Kinase Small-molecule Inhibitor in Rats Are Strain-dependent von Bhaskaran, Manoj, Cornwell, Paul D., Sorden, Steven D., Elwell, Michael R., Russell, Natalie R., Pritt, Michael L., Vahle, John L.

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Chronic Toxicology Studies of Basal Insulin Peglispro in Rats and Dogs: A Novel, PEGylated Insulin Lispro Analog with a Prolonged Duration of Action von Byrd, Richard A., Blackbourne, Jamie L., Knadler, Mary Pat, Schultze, Albert E., Vahle, John L.

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Lack of Bone Neoplasms and Persistence of Bone Efficacy in Cynomolgus Macaques After Long‐Term Treatment With Teriparatide [rhPTH(1‐34)] von Vahle, John L, Zuehlke, Ulrich, Schmidt, Allen, Westmore, Michael, Chen, Peiqi, Sato, Masahiko

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An Investigative Study of Pancreatic Exocrine Biomarkers, Histology, and Histomorphometry in Male Zucker Diabetic Fatty (ZDF) Rats Given Dulaglutide by Subcutaneous Injection Twice... von Usborne, Amy, Byrd, Richard A., Meehan, James, Blackbourne, Jamie L., Sullivan, John, Poitout-Belissent, Florence, Prefontaine, Annick, Martin, Jennifer A., Vahle, John L.

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Effects of Dulaglutide on Thyroid C Cells and Serum Calcitonin in Male Monkeys von Vahle, John L, Byrd, Richard A, Blackbourne, Jamie L, Martin, Jennifer A, Sorden, Steven D, Ryan, Thomas, Pienkowski, Thomas, Wijsman, John A, Smith, Holly W, Rosol, Thomas J

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Nonclinical pharmacology and toxicology of the first biosimilar insulin glargine drug product (BASAGLAR®/ABASAGLAR®) approved in the European Union von Byrd, Richard A., Owens, Rebecca A., Blackbourne, Jamie L., Coutant, David E., Farmen, Mark W., Michael, M. Dodson, Moyers, Julie S., Schultze, A. Eric, Sievert, Michael K., Tripathi, Niraj K., Vahle, John L.

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Carcinogenicity Assessments: The Debate Continues von Vahle, John L.

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Teriparatide [PTH(1–34)] Strengthens the Proximal Femur of Ovariectomized Nonhuman Primates Despite Increasing Porosity von Sato, Masahiko, Westmore, Michael, Ma, Yanfei L, Schmidt, Allen, Zeng, Qing Q, Glass, Emmett V, Vahle, John, Brommage, Robert, Jerome, Christopher P, Turner, Charles H

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Best Practices for Clinical Pathology Testing in Carcinogenicity Studies von Young, Jamie K., Hall, Robert L., O’Brien, Peter, Strauss, Volker, Vahle, John L.

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International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) progress to date and future plans von Keenan, Charlotte M., Baker, Julia F., Bradley, Alys E., Goodman, Dawn G., Harada, Takanori, Herbert, Ronald, Kaufmann, Wolfgang, Kellner, Rupert, Mahler, Beth, Meseck, Emily, Nolte, Thomas, Rittinghausen, Susanne, Vahle, John, Yoshizawa, Katsuhiko

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