Dirk Mariën
Janssen Pharmaceutica
6 Papers
51 Citations
Dirk Mariën is an academic researcher from Janssen Pharmaceutica. The author has contributed to research in topics: Juvenile animal & Pharmacokinetics. The author has an hindex of 5, co-authored 6 publications.
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Papers
An Analysis of Pharmaceutical Experience with Decades of Rat Carcinogenicity Testing: Support for a Proposal to Modify Current Regulatory Guidelines
Frank D. Sistare,Daniel Morton,Carl L. Alden,Joel Christensen,Douglas A. Keller,Sandra De Jonghe,Richard D. Storer,M. Vijayaraj Reddy,Andrew R. Kraynak,Bruce A. Trela,Jean-Guy Bienvenu,Sivert Bjurström,Vanessa Bosmans,David Brewster,Karyn Colman,Mark A. Dominick,John Evans,James R. Hailey,Lewis B. Kinter,Matt Liu,Charles R. Mahrt,Dirk Mariën,James R. Myer,Richard Perry,Daniel Potenta,Arthur Roth,Philip Sherratt,Thomas Singer,Rabih Slim,Keith A. Soper,Ronny Fransson-Steen,James H. Stoltz,Oliver C. Turner,Susan E. Turnquist,Marjolein van Heerden,Jochen Woicke,Joseph J. DeGeorge +36 more
TL;DR: A proposal to refine regulatory criteria for conducting a two-year rat study to be based on assessment of histopathologic findings from a rat six- month study, evidence of hormonal perturbation, genetic toxicology results, and the findings of a six-month transgenic mouse carcinogenicity study has the potential to eliminate over 40% of rat two- year testing on new pharmaceuticals without compromise to patient safety.
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The effect of macrophage and angiogenesis inhibition on the drug release and absorption from an intramuscular sustained-release paliperidone palmitate suspension.
Nicolas Darville,Marjolein van Heerden,Dirk Mariën,Marc De Meulder,Stefaan Rossenu,An Vermeulen,An Vynckier,Sandra De Jonghe,Patrick Sterkens,Pieter Annaert,Guy Van den Mooter +10 more
TL;DR: The correlation of the pharmacokinetic data with the histopathological findings indicated that the macrophage infiltration, with subsequent phagocytosis of an important fraction of the PP-LAI dose, actively contributed to the observed PAL plasma exposures by promoting the prodrug dissolution and conversion to the active.
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The value of juvenile animal studies "What have we learned from preclinical juvenile toxicity studies? II"
Graham Bailey,Dirk Mariën +1 more
TL;DR: A more extensive survey was commissioned by the ILSI/HESI DART Technical Committee to clarify what has been learned for the safety assessment for pediatrics and found many of the studies were large, lengthy, complex, included parameters that mirrored the adult studies and yielded no new or useful information.
44
Carcinogenicity in rats of the SGLT2 inhibitor canagliflozin.
Sandra De Jonghe,Jim Proctor,Petra Vinken,Bianca Feyen,Inneke Wynant,Dirk Mariën,Helena Geys,Rao N.V.S. Mamidi,Mark D. Johnson +8 more
TL;DR: In conclusion, Leydig cell tumors were associated with increased luteinizing hormone levels and pheochromocytomas were most likely related to glucose malabsorption and altered calcium homeostasis.
42
Juvenile animal testing of hydroxypropyl-β-cyclodextrin in support of pediatric drug development.
Luc De Schaepdrijver,Dirk Mariën,Cheyma Rhimi,Marieke Voets,Marjolein van Heerden,Lieve Lammens +5 more
TL;DR: With increasing age a more effective renal clearance of HP-β-CD is present in line with the postnatal functional maturation of the kidney and an increase in soft stools was seen which was related to osmotic water retention in the large intestine following oral administration.
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