Zobrazeno 1 - 10
of 14
pro vyhledávání: '"Dirk Mariën"'
Publikováno v:
Reproductive Toxicology. 99:135
Publikováno v:
Reproductive Toxicology. 64:141-150
The fertility study design recommended in the ICH S5(R2) Harmonised Guideline for Detection of Toxicity to Reproduction for Medicinal Products emphasizes the importance of histopathological endpoints next to a pairing assessment in evaluating male fe
Autor:
Dirk Mariën, Luc De Schaepdrijver, Marieke Voets, Lieve Lammens, Marjolein van Heerden, Cheyma Rhimi
Publikováno v:
Reproductive Toxicology. 56:87-96
Hydroxypropyl-β-cyclodextrin (HP-β-CD) is being explored as excipient for administration of poorly soluble NCE's in pediatrics. In support of pharmaceutical development, non-clinical studies were performed to investigate whether oral and intravenou
Autor:
Petra Vinken, Sandra De Jonghe, Jim Proctor, Mark D. Johnson, Bianca Feyen, Dirk Mariën, Helena Geys, Inneke Wynant, Rao N.V.S. Mamidi
Publikováno v:
Chemico-Biological Interactions. 224:1-12
The carcinogenicity potential of canagliflozin, an inhibitor of SGLT2, was evaluated in a 2-year rat study (10, 30, and 100 mg/kg). Rats showed an increase in pheochromocytomas, renal tubular tumors, and testicular Leydig cell tumors. Systemic exposu
Autor:
Dirk Mariën, Graham Bailey
Publikováno v:
Birth Defects Research Part B: Developmental and Reproductive Toxicology. 92:273-291
Recent changes in the regulations from the FDA and EMA have shifted the focus of juvenile toxicity studies more to the safe use of all pharmaceuticals and the absence of label or safety information for the pediatric population. Unlike other regulator
Autor:
Petra Vinken, L. Van den Sande, Tim Erkens, A. Kegels, Nick Goeminne, M. van Heerden, Dirk Mariën, J. Boonen
Publikováno v:
Toxicology Letters. 295:S83
Autor:
Luc De Schaepdrijver, Rémi Mounier, Graham P. Bailey, Freddy Schoetens, Kirsten van Dycke, Dirk Mariën
Publikováno v:
Reproductive Toxicology. 80:28
Autor:
Graham P. Bailey, Dirk Mariën
Publikováno v:
Reproductive Toxicology. 28:226-229
Juvenile toxicity studies have assumed a higher priority within the pharmaceutical industry following recent changes in regulations. The requirement and designs of these studies should be on a ‘case-by-case’ basis. Discussions have suggested that
Autor:
Stefaan Rossenu, An Vermeulen, Marc De Meulder, Marjolein van Heerden, Dirk Mariën, Patrick Sterkens, Sandra De Jonghe, Nicolas Darville, Pieter Annaert, Guy Van den Mooter, An Vynckier
Publikováno v:
Journal of controlled release : official journal of the Controlled Release Society. 230
The intramuscular (IM) administration of long-acting injectable (LAI) aqueous nano-/microsuspensions elicits a chronic granulomatous injection site reaction, which recently has been hypothesized to drive the (pro)drug dissolution and systemic absorpt
Autor:
Graham P, Bailey, Dirk, Mariën
Publikováno v:
Birth defects research. Part B, Developmental and reproductive toxicology. 92(4)
Recent changes in the regulations from the FDA and EMA have shifted the focus of juvenile toxicity studies more to the safe use of all pharmaceuticals and the absence of label or safety information for the pediatric population. Unlike other regulator