Search Results - "WEINBAUER, Gerhard F"

Physiology and Endocrinology of the Ovarian Cycle in Macaques by Weinbauer, Gerhard F., Niehoff, Marc, Niehaus, Michael, Srivastav, Shiela, Fuchs, Antje, Van Esch, Eric, Cline, J. Mark

“…Macaques provide excellent models for preclinical testing and safety assessment of female reproductive toxicants. Currently, cynomolgus monkeys are the…”
Get full text

Developmental and reproductive toxicology studies in nonhuman primates by Chellman, Gary J., Bussiere, Jeanine L., Makori, Norbert, Martin, Pauline L., Ooshima, Yojiro, Weinbauer, Gerhard F.

“…Developmental and reproductive toxicology testing in nonhuman primates (NHPs) has become more common due to the increasing number of biopharmaceuticals in drug…”
Get full text

Comparing rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on systemic dose and developmental effects by Theunissen, Peter T., Beken, Sonia, Beyer, Bruce, Breslin, William J., Cappon, Gregg D., Chen, Connie L., Chmielewski, Gary, de Schaepdrijver, Luc, Enright, Brian, Foreman, Jennifer E., Harrouk, Wafa, Hew, Kok-Wah, Hoberman, Alan M., Y. Hui, Julia, Knudsen, Thomas B., Laffan, Susan B., Makris, Susan L., Martin, Matthew, McNerney, Mary Ellen, Siezen, Christine L., Stanislaus, Dinesh J., Stewart, Jane, Thompson, Kary E., Tornesi, Belen, Van der Laan, Jan Willem, Weinbauer, Gerhard F., Wood, Sandra, Piersma, Aldert H.

“…A database of embryo-fetal developmental toxicity (EFDT) studies of 379 pharmaceutical compounds in rat and rabbit was analyzed for species differences based…”
Get full text

Summary Comparison of Female Reproductive System in Human and the Cynomolgus Monkey (Macaca fascicularis) by Van Esch, Eric, Cline, J. Mark, Buse, Eberhard, Wood, Charles E., de Rijk, Eveline P. C. T., Weinbauer, Gerhard F.

“…Competing Interests: This article was sponsored by Covance Inc. and Schering-Plough. Gerhard F. Weinbauer and Eberhard Buse are employed by Covance Inc…”
Get full text

Selected Background Findings and Interpretation of Common Lesions in the Female Reproductive System in Macaques by Cline, J. Mark, Wood, Charles E., Vidal, Justin D., Tarara, Ross P., Buse, Eberhard, Weinbauer, Gerhard F., de Rijk, Eveline P. C. T., van Esch, Eric

“…The authors describe a selection of normal findings and common naturally occurring lesions in the reproductive system of female macaques, including changes in…”
Get full text

Organization of Seminiferous Epithelium in Primates: Relationship to Spermatogenic Efficiency, Phylogeny, and Mating System by WISTUBA, Joachim, SCHROD, Annette, GREVE, Burkhard, HODGES, J. Keith, ASLAM, Humaira, WEINBAUER, Gerhard F, LUETJENS, C. Marc

“…The succession in time and space of specific germ cell associations, denoted as spermatogenic stages, is a typical feature of mammalian spermatogenesis. The…”
Get full text

Toxicologic Pathology Forum: Opinion on Sexual Maturity and Fertility Assessment in Long-tailed Macaques (Macaca fascicularis) in Nonclinical Safety Studies by Mecklenburg, Lars, Luetjens, C. Marc, Weinbauer, Gerhard F.

“…If nonhuman primates represent the only relevant species for nonclinical safety evaluation of biotechnology-derived products, male and female fertility effects…”
Get full text

Enhanced normograms and pregnancy outcome analysis in nonhuman primate developmental toxicity studies by Grossmann, Heiko, Weinbauer, Gerhard F., Baker, Ann, Fuchs, Antje, Luetjens, C. Marc

“…•Assess and benchmark pregnancy outcome data; of regulatory ICH driven DART studies.•New concept of separate normograms through statistical analysis.•Enhanced…”
Get full text

Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment by Brennan, Frank R., Cavagnaro, Joy, McKeever, Kathleen, Ryan, Patricia C., Schutten, Melissa M., Vahle, John, Weinbauer, Gerhard F., Marrer-Berger, Estelle, Black, Lauren E.

“…Monoclonal antibodies (mAbs) are improving the quality of life for patients suffering from serious diseases due to their high specificity for their target and…”
Get full text

Genome typing of nonhuman primate models: implications for biomedical research by Haus, Tanja, Ferguson, Betsy, Rogers, Jeffrey, Doxiadis, Gaby, Certa, Ulrich, Rose, Nicola J, Teepe, Robert, Weinbauer, Gerhard F, Roos, Christian

“…Highlights • Currently, full consideration is not being given to the genetic variation in nonhuman primates (NHP). • As models for human disease, it is…”
Get full text

Developmental immunotoxicology assessment of rituximab in cynomolgus monkeys by Vaidyanathan, Anu, McKeever, Kathleen, Anand, Banmeet, Eppler, Steve, Weinbauer, Gerhard F, Beyer, Joseph C

“…Rituximab is a chimeric murine/human-engineered immunoglobulin (Ig) G1 anti-CD20 monoclonal antibody, selectively depleting CD20-expressing cells in peripheral…”
Get full text

Points to Consider in Designing and Conducting Juvenile Toxicology Studies by Kim, Norman N., Parker, Robert M., Weinbauer, Gerhard F., Remick, Amera K., Steinbach, Thomas

“…In support of a clinical trial in the pediatric population, available nonclinical and clinical data provide input on the study design and safety monitoring…”
Get full text

The cynomolgus monkey as a model for developmental toxicity studies: variability of pregnancy losses, statistical power estimates, and group size considerations by Jarvis, Philip, Srivastav, Shiela, Vogelwedde, Elvira, Stewart, Jane, Mitchard, Terri, Weinbauer, Gerhard F.

“…BACKGROUND: This work evaluates pregnancy and infant loss in 1,069 vehicle‐treated cynomolgus monkeys from 78 embryo‐fetal development (EFD) studies and 14…”
Get full text

Germ Cell-Specific Cyclic Adenosine 3′,5′-Monophosphate Response Element Modulator Expression in Rodent and Primate Testis Is Maintained Despite Gonadotropin Deficiency by Behr, Rüdiger, Weinbauer, Gerhard F.

“…Abstract cAMP response element modulator (CREM) is an important component of the cAMP-mediated signaling pathway and is essential for differentiation of…”
Get full text

Developmental Toxicity Testing of Biopharmaceuticals in Nonhuman Primates: Previous Experience and Future Directions by Martin, Pauline L., Weinbauer, Gerhard F.

“…Developmental toxicity studies for pharmaceutical safety testing are designed to evaluate potential adverse effects of drug treatment on pregnancy and on the…”
Get full text

The enhanced pre- and postnatal study for nonhuman primates: Update and perspectives by Weinbauer, Gerhard F., Fuchs, Antje, Niehaus, Michael, Luetjens, Craig M.

“…The enhanced pre‐ and postnatal (ePPND) study design has been developed in response to new scientific knowledge and subsequent guideline changes, that is, ICH…”
Get full text

Assessment of placental transfer and the effect on embryo-fetal development of a humanized monoclonal antibody targeting lymphotoxin-alpha in non-human primates by Wang, Hong, Schuetz, Chris, Arima, Akihiro, Chihaya, Yutaka, Weinbauer, Gerhard F., Habermann, Gunnar, Xiao, Jim, Woods, Cynthia, Grogan, Jane, Gelzleichter, Thomas, Cain, Gary

“…•Placental transfer of therapeutic IgG1 occurs at low level in non-human primates.•Pateclizumab did not induce maternal/fetal toxicity when dosed from GD20 to…”
Get full text

Comparison of rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on the nature and severity of developmental effects by Theunissen, Peter T., Beken, Sonja, Beyer, Bruce K., Breslin, William J., Cappon, Gregg D., Chen, Connie L., Chmielewski, Gary, De Schaepdrijver, Luc, Enright, Brian, Foreman, Jennifer E., Harrouk, Wafa, Hew, Kok-Wah, Hoberman, Alan M., Hui, Julia Y., Knudsen, Thomas B., Laffan, Susan B., Makris, Susan L., Martin, Matt, McNerney, Mary Ellen, Siezen, Christine L., Stanislaus, Dinesh J., Stewart, Jane, Thompson, Kary E., Tornesi, Belen, Van der Laan, Jan Willem, Weinbauer, Gerhard F., Wood, Sandra, Piersma, Aldert H.

“…Regulatory non-clinical safety testing of human pharmaceuticals typically requires embryo-fetal developmental toxicity (EFDT) testing in two species (one…”
Get full text

Inhibin B as a Marker of Sertoli Cell Damage and Spermatogenic Disturbance in the Rat by Pfaff, Tamara, Rhodes, Jon, Bergmann, Martin, Weinbauer, Gerhard F.

“…This study was designed to determine the effects of Compound A on spermatogenesis including assessment of inhibin B levels and on fertility in the male rat…”
Get full text

Primate spermatogenesis: new insights into comparative testicular organisation, spermatogenic efficiency and endocrine control by Marc Luetjens, C., Weinbauer, Gerhard F., Wistuba, Joachim

“…Owing to the close phylogenetic relationship of Platyrrhini (New World monkeys) and Catarrhini (Old World monkeys) to man, nonhuman primates are often used as…”
Get full text