Results 221 to 230 of about 1,676,195 (294)

Maternal and Neonatal Complications Associated with Breast Cancer Systemic Treatments—A VigiBase Disproportionality Analysis Study

Clinical Pharmacology &Therapeutics, EarlyView.
Pregnancy‐associated breast cancer (PrBC) presents therapeutic challenges. Understanding maternal–fetal safety of systemic anticancer therapies is critical. We performed a case/non‐case disproportionality analysis using the WHO global pharmacovigilance database up to January 2024, to evaluate maternal–fetal outcomes associated with breast cancer (BC ...
Rayan Kabirian, Floriane Jochum, Elise Dumas, Florence Coussy, Kevin Bihan, Bénédicte Lebrun‐Vignes, Barbara Pistilli, Marc‐Antoine Benderra, Lise Selleret, Laurent Chouchana, Fabien Reyal, Anne‐Sophie Hamy, Paul Gougis   +12 more
wiley   +1 more source

Non-invasive prediction of blastocyst implantation, ongoing pregnancy and live birth, by mass spectrometry lipid fingerprinting. [PDF]

JBRA Assist Reprod, 2016
Borges E, Braga DP, Setti AS, Montanni DA, Cabral EC, Eberlin MN, Turco EG, Iaconelli A.   +7 more
europepmc   +1 more source

Long‐Acting Therapeutics in Pediatric Health: Bridging Innovation and Access

Clinical Pharmacology &Therapeutics, EarlyView.
Children have distinct therapeutic needs arising from age‐dependent physiology, disease epidemiology, formulation requirements, dosing considerations, and safety vulnerabilities. Despite substantial reductions in childhood mortality over the past three decades, nearly 5 million children under five died in 2023, with infectious diseases continuing to ...
Prajith Venkatasubramanian, Moherndran Archary, Daniel B. Hawcutt, Rachel Daley, Edmund Capparelli, Adeniyi Olagunju   +5 more
wiley   +1 more source

Special Populations in Pivotal Clinical Trials: Eligibility and Supporting Evidence for Exclusion in EMA‐Authorised Medicines

Clinical Pharmacology &Therapeutics, EarlyView.
Evidence on the efficacy and safety of medicines supporting marketing authorization is largely derived from randomized controlled trials, yet these trials often exclude populations likely to use the medications in clinical practice. This study assessed eligibility of special populations, defined as pregnant and breast‐feeding individuals, elderly ...
Maja J. Jørgensen, Débora D. Gräf, Christine E. Hallgreen   +2 more
wiley   +1 more source

Medication Use During Breastfeeding—An Understudied Population: A Five‐Year Experience in the Pharmacovigilance Center of Lyon

Clinical Pharmacology &Therapeutics, EarlyView.
Medication use during breastfeeding is common, yet data on drug transfer into breast milk and infant exposure remain limited. This study describes real‐world requests concerning medication compatibility with breastfeeding managed by the Lyon pharmacovigilance center over five years.
Blandine Bertin, Aurore Gouraud, Anthony Facile, Fanny Ledys, Sabrina Pierre, Véronique Pizzoglio, Thierry Vial, Marine Auffret, Marina Atzenhoffer   +8 more
wiley   +1 more source

Elevated serum estradiol levels in artificial autologous frozen embryo transfer cycles negatively impact ongoing pregnancy and live birth rates. [PDF]

J Assist Reprod Genet, 2017
Fritz R, Jindal S, Feil H, Buyuk E.
europepmc   +1 more source

The EMA Qualification Opinion for CYP Inhibition‐Mediated Drug–Drug Interaction Predictions: Implications for PBPK Credibility Assessment in the Era of ICH M15

Clinical Pharmacology &Therapeutics, EarlyView.
Clinical pharmacology and pharmacometrics teams are now being encouraged to implement the ICH M15 framework in drug development to support model‐informed decisions in regulatory submissions. Although model performance is an important component of model evaluation, regulatory confidence also depends on the intended context of use (CoU) and the ...
Karen Rowland Yeo, Sibylle Neuhoff, Oliver Hatley, Iain Gardner, Céline Brochot, Frédéric Y. Bois, Masoud Jamei   +6 more
wiley   +1 more source

ESG Ratings and Firms' Engagement in Global Innovation Ecosystems: Implications for Green Innovation Capacity

Corporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT The increasing salience of climate change has intensified attention to the roe of ESG ratings in shaping firms' green innovation. We examine the link between ESG performance and green innovation, highlighting the role of participation in global innovation networks.
Miaomiao Tao, David Roubaud, Mingzhi Zhang, Qianli Ma   +3 more
wiley   +1 more source

A double-blind multi-centre randomised placebo-controlled trial of doxycycline in women with recurrent miscarriage and chronic endometritis defined by CD138 positive stromal cells. [PDF]

Hum Reprod
Odendaal J, Black N, Fishwick K, Thornton J, Makwana K, Ewington L, Larsen K, Hawkes A, Leeson C, Fisher J, Lall R, Guck J, Coomarasamy A, Granne I, Underwood M, Bouliotis G, Quenby S.   +16 more
europepmc   +1 more source

Digital and Gender Attributes of IC in Sustainability Reporting of Italian Firms

Corporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT Italian listed enterprises increasingly rely on intellectual capital (IC) to enhance competitiveness and sustainability performance. As IC, comprising human, structural, and relational capital, is rarely recognised in financial statements due to the lack of standardised frameworks, its disclosure has gained relevance in sustainability ...
Alessandra Buonasera, Simona Catuogno
wiley   +1 more source