Results 191 to 200 of about 77,040 (258)

A White Paper on Advancing Long‐Acting Therapeutics for Maternal and Pediatric Health by Bridging Gaps in Clinical Research, Access and Regulation

Clinical Pharmacology &Therapeutics, EarlyView.
As use cases for long‐acting therapeutics expand across clinical indications, there is a critical need to ensure the inclusion of women who are pregnant or breastfeeding, infants and children—populations with a historical gap in the availability of interventions already approved for use in adults.
Moherndran Archary, Robert Bies, Osei Boateng, Rachel Daley, Pierre Gashema, Mili Karina, Emily Njuguna, Sharon Nachman, Nathaniel Nkrumah, Carolyne Odula, Andrew Owen, Ethel D. Weld, Prajith Venkatasubramanian, Adeniyi Olagunju, on behalf of the Community of Practice for Long‐acting Therapeutics for Maternal and Paediatric Health, Rana Abutaima, Dorothy Akongo, Abdulnaser Alsharaa, Moherndran Archary, Shakir Atoyebi, Benoit Bestgen, Robert Bies, Osei Boateng, Andrew Butler, Edmund Capparelli, Rachel Daley, Layla Davies, Joelle Dountio, Henry Enzama, Pierre Gashema, Katila George, Dan Hawcutt, Rene Holm, Patrick Gad Iradukunda, Elodie Jambert, Mili Karina, Linda Lewis, Grace Miheso, Sebastien Morin, Andrew Morrison, Sharon Nachman, Shadia Nakalema, Emily Njunga, Nathaniel Nkrumah, Carolyne Odula‐Obonyo, Brenda Okware, Adeniyi Olagunju, Andrew Owen, Martina Penazzato, Natella Rakhmanina, Mphako Brighton Ratlabyana, Rachel Scott, Kimberly Struble, Andre‐Marie Tchouatieu, Catherine Unsworth, Prajith Venkatasubramanian, Catriona Waitt, Ethel Weld, Janine Winterbottom, Leena Zino   +59 more
wiley   +1 more source

Short- and Long-Acting Psychedelics: Structure-Activity Relationships, Pharmacology, and Implications for Neuropsychiatric Therapeutics. [PDF]

ACS Chem Neurosci
Bhat A, Zolali E, Sakib MA, Rahimian M, McMahon LR, German N, Obeng S.   +6 more
europepmc   +1 more source

Intravenous Lipopolysaccharide Challenge in Healthy Participants Reveals Pharmacodynamic Markers in Blood and Bone Marrow for Early‐Phase Oncology Drug Development

Clinical Pharmacology &Therapeutics, EarlyView.
Demonstrating pharmacological effects in early‐phase oncology clinical trials remains challenging, largely due to the lack of robust pharmacodynamic markers. Lipopolysaccharide (LPS) is used as an immune challenge agent in healthy participants to study drugs for autoimmune conditions.
Igor Radanović, Ingrid Tomljanović, Wieke H. Grievink, Diana R. Pereira, Michelle Osse, Peter van Balen, Maria J. Juachon, Marieke L. de Kam, Lisa Pagan, Manon A.A. Jansen, Matthijs Moerland, Jacobus J. Bosch   +11 more
wiley   +1 more source

Pharmacogenes Associated with Suicidal Behavior: Addressing a Potential Therapeutic Window. [PDF]

Actas Esp Psiquiatr
Becerra López JA, Genis Mendoza AD, Nicolini H.   +2 more
europepmc   +1 more source

Tolvaptan pharmacokinetics and pharmacodynamics in adolescents with autosomal dominant polycystic kidney disease. [PDF]

Eur J Pediatr
Shoaf SE, Sikes K.
europepmc   +1 more source

A plain language summary of the BASIS study looking at people living with severe hemophilia A or B with inhibitors and being treated with marstacimab. [PDF]

Ther Adv Hematol
Matino D, Acharya SS, Taylor CT, Sun P, Agathon D, Raje S, Gould T, Palladino A, Mahlangu J.   +8 more
europepmc   +1 more source

Population Pharmacokinetic/Pharmacodynamic Modeling of Donidalorsen, an Antisense Oligonucleotide in Development for Prophylaxis of Hereditary Angioedema. [PDF]

CPT Pharmacometrics Syst Pharmacol
Diep JK, Liu M, Singh P, Dorow S, Cohn DM, Bordone L, Newman KB, Gao X.   +7 more
europepmc   +1 more source

First-in-human, phase 1 study of CM512, a TSLP/IL-13 bispecific antibody, in healthy volunteers: safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. [PDF]

Front Immunol
Cheng Y, Liu Q, Li M, Xie Y, Men Y, He M, Wang H, Feng X, Zeng M, Zhang L, Chen B, Li J, Feng P.   +12 more
europepmc   +1 more source

Genetic and nongenetic factors affecting vancomycin population pharmacokinetics and pharmacodynamics: A systematic review.

Indian J Pharmacol
Pradana DA, Marfianti E, Wibowo A.
europepmc   +1 more source