Nonclinical considerations for support of pregnancy and lactation in clinical trials

Source
Birth defects research - ISSN 2472-1727-118:6 (2026) p.
Author(s)
    Dinesh Stanislaus, Christopher J. Bowman, Kimberly C. Brannen, Sarah N. Campion, Laura M. Carlson, Stephan Chalon, Anthony M. DeLise, Claudia Demarta-Gatsi, Brian P. Enright, Wendy Halpern, Shermaine Mitchell-Ryan, Vicki Sutherland, Karen Thacker, Kary Thompson, Belen Tornesi, Steven Van Cruchten, Ronald L. Wange, Tacey White, Connie L. Chen

Neonatal PBPK model of midazolam and its metabolites for perinatal asphyxia and therapeutic hypothermia

Source
British journal of clinical pharmacology - ISSN 0306-5251- (2026) p.
Author(s)
    Karen Leys, Agustos Ozbey, Miao-Chan Huang, Julia Macente, Marina Stroe, Timo Robert de Haan, Floris Groenendaal, Evelyne Jacqz-Aigrain, Saskia N. de Wildt, Karel Allegaert, Steven Van Cruchten, Anne Smits, Pieter Annaert

Hypothesis-driven approach to developmental toxicity assessment : using mechanistic information to inform testing

Source
Reproductive toxicology - ISSN 0890-6238-140 (2026) p. 1-7
Author(s)
    George Daston, Matthew Burbank, Florian Gautier, Barbara F. Hales, Amer Jamalpoor, Yasunari Kanda, Susan Makris, Aldert H. Piersma, Nicola Powles-Glover, Sonya Sobrian, Vicki Sutherland, Steven Van Cruchten, Ronald L. Wange, Connie L. Chen

Minimizing use of nonhuman primates to inform risk to fertility and of adverse pregnancy outcomes with pharmaceuticals

Source
Regulatory toxicology and pharmacology - ISSN 0273-2300-164 (2026) p. 1-21
Author(s)
    Christopher J. Bowman, Ann Baker, Diann L. Blanset, Kimberly C. Brannen, Gary J. Chellman, Brian Enright, Wendy Halpern, Bethany R. Hannas, Kazushige Maki, Fumito Mikashima, Shermaine Mitchell-Ryan, Eve Mylchreest, Manjunatha K. Nanjappa, Helen Prior, Puck Roos, Dinesh Stanislaus, Angela R. Stermer, Jane Stewart, Katie Turner, Steven Van Cruchten, Peter J.K. van Meer, Justin D. Vidal, Ronald L. Wange, Connie Chen, Peter Theunissen

New approach methodologies for assessing developmental toxicity of pharmaceuticals : case examples and future directions

Source
Reproductive toxicology - ISSN 0890-6238-137 (2025) p. 1-8
Author(s)
    Nicola Powles-Glover, Allen R. Kaczor, Steven Van Cruchten, Christopher J. Bowman, Kimberly C. Brannen, Claudia Demarta-Gatsi, Isabelle LeConte, Amer Jamalpoor, Fumito Mikashima, Shermaine Mitchell-Ryan, Dinesh Stanislaus, Peter Theunissen, Belen Tornesi, Ronald L. Wange, Connie L. Chen