Search Results - "Vahle, John L"

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

“…Industry representatives on the ICH S1B(R1) Expert Working Group (EWG) worked closely with colleagues from the Drug Regulatory Authorities to develop an…”
Get full text

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

“…A long-term study was conducted in female F344 rats to determine the relative importance of dose, treatment duration, and age at initiation of treatment on the…”
Get full text

Skeletal Changes in Rats Given Daily Subcutaneous Injections of Recombinant Human Parathyroid Hormone (1-34) for 2 Years and Relevance to Human Safety by 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.

“…Fischer 344 rats (60/sex/group) were given daily subcutaneou s injections of recombinant human parathyroi d hormone (PTH)(1-34) for 2 years at doses of 0, 5,…”
Get full text

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

“…This article summarizes a continuing education presentation on immunogenicity that was part of a continuing education course entitled, “Clinical Pathology of…”
Get full text

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

“…The delivery of biotherapeutic molecules (antibodies, proteins, peptides) and nucleic acids via the respiratory route has presented challenges for regulatory…”
Get full text

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

“…In animal studies, light microscopic examination remains an important tool in the detection and characterization of effects on the skeleton. In the case of…”
Get full text

Proceedings of the 2009 National Toxicology Program Satellite Symposium by Bach, Ute, Hailey, James R., Hill, Georgette D., Kaufmann, Wolfgang, Latimer, Kenneth S., Malarkey, David E., Maronpot, Robert M., Miller, Rodney A., Moore, Rebecca R., Morrison, James P., Nolte, Thomas, Rinke, Matthias, Rittinghausen, Susanne, Suttie, Andrew W., Travlos, Gregory S., Vahle, John L., Willson, Gabrielle A., Elmore, Susan A.

“…The National Toxicology Program (NTP) Satellite Symposium is a one-day meeting that is held in conjunction with the annual Society of Toxicologic Pathology…”
Get full text

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

“…The objective of the pharmaceutical industry is to develop new drugs that are safe for human use. In many cases, the accepted approach codified in guidance…”
Get full text

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 Toxicology Studies by 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.

“…In December 2021, the United States Food and Drug Administration (FDA) issued the final guidance for industry titled Pathology Peer Review in Nonclinical…”
Get full text

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

“…Basal insulin peglispro (BIL) consists of insulin lispro with a 20-kDa polyethylene glycol (PEG) moiety covalently attached to lysine B28. Because chronic…”
Get full text

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

“…Inhibitors of Bruton’s tyrosine kinase (BTK) are under development as potential therapies for various autoimmune diseases. In repeat-dose toxicity studies,…”
Get full text

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

“…Toxicogenomics held great promise as an approach to enable early detection of toxicities induced by xenobiotics; however, there remain questions regarding the…”
Get full text

Chronic Toxicity and Carcinogenicity Studies of the Long-Acting GLP-1 Receptor Agonist Dulaglutide in Rodents by 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

“…The tumorigenic potential of dulaglutide was evaluated in rats and transgenic mice. Rats were injected sc twice weekly for 93 weeks with dulaglutide 0, 0.05,…”
Get full text

An Investigative Study of Pancreatic Exocrine Biomarkers, Histology, and Histomorphometry in Male Zucker Diabetic Fatty (ZDF) Rats Given Dulaglutide by Subcutaneous Injection Twice Weekly for 13 Weeks by Usborne, Amy, Byrd, Richard A., Meehan, James, Blackbourne, Jamie L., Sullivan, John, Poitout-Belissent, Florence, Prefontaine, Annick, Martin, Jennifer A., Vahle, John L.

“…Glucagon-like peptide-1 (GLP-1) receptor agonist therapy has been implicated as a possible risk factor for acute pancreatitis in patients with type 2 diabetes…”
Get full text

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

“…In rats, teriparatide [rhPTH(1‐34)] causes marked increases in bone mass and osteosarcoma. In primates, teriparatide causes lesser increases in bone mass, and…”
Get full text

Effects of Dulaglutide on Thyroid C Cells and Serum Calcitonin in Male Monkeys by 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

“…Glucagon-like peptide-1 (GLP-1) receptor agonists, used for the treatment of type 2 diabetes, have caused hyperplasia/neoplasia of thyroid C cells in rodent…”
Get full text

Nonclinical pharmacology and toxicology of the first biosimilar insulin glargine drug product (BASAGLAR®/ABASAGLAR®) approved in the European Union by 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.

“…Basaglar®/Abasaglar® (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar…”
Get full text

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

Get full text

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

“…The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity…”
Get full text

Effects of the GLP-1 Receptor Agonist Dulaglutide on the Structure of the Exocrine Pancreas of Cynomolgus Monkeys by Vahle, John L., Byrd, Richard A., Blackbourne, Jamie L., Martin, Jennifer A., Sorden, Steven D., Ryan, Thomas, Pienkowski, Thomas, Rosol, Thomas J., Snyder, Paul W., Klöppel, Günter

“…Clinical and nonclinical studies have implicated glucagon-like peptide-1 (GLP-1) receptor agonist therapy as a risk factor for acute pancreatitis in patients…”
Get full text