Results 221 to 230 of about 7,536,002 (274)

Combining Observational Studies to Reduce Multiple Biases. [PDF]

Epidemiology
Cole SR, Zivich PN, Shook-Sa BE, Richardson DB, Hudgens MG, Edwards JK.   +5 more
europepmc   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Pharmaceutical Industry Perspectives on Exposure-Response Confounding in Large Molecule Therapeutics: Results From an IQ Consortium Survey. [PDF]

CPT Pharmacometrics Syst Pharmacol
Salama E, Lamba M, Ait-Oudhia S, Wang E, Semiond D, Li Z, Long T, Suryawanshi S, Arrington L, Gao W, Guan X, Giovinazzo H, Miles D, Turner DC.   +13 more
europepmc   +1 more source

Case‐malformed signal detection and prioritisation using EUROmediCAT data for pharmacovigilance in pregnancy

British Journal of Clinical Pharmacology, EarlyView.
Aim Many women take medications during pregnancy. However, the risk to the fetus from most medications is uncertain. Congenital anomalies are one of the leading causes of infant death and contribute to long‐term disability. Signal detection methods can be used to systematically identify possible medication–anomaly associations that require further ...
Hannah Johnson, Helen Dolk, Maria Loane, Christine Damase‐Michel, Joanne Given, Hedvig Nordeng, Jorieke E. H. Bergman, Iain Carey, Elly Den Hond, Ester Garne, Florence Rouget, Lea Bruneau, Isabelle Monier, Anke Rissmann, Mary O'Mahony, Miriam Gatt, Renée Lutke, Joanna Sichitiu, Elisa Ballardini, Alessio Coi, Clara Cavero Carbonell, David Tucker, Joan Morris   +22 more
wiley   +1 more source

Potential Health Impacts of Jet Fuel Exposure on the Hematologic and Cardiovascular Systems. [PDF]

J Occup Environ Med
Ross AM, Vidal J, Freedman AN, Kolanowski A, Miller SL, Goodman SJ, Sprowles JLN, Lindahl AJ, Snow SJ, Eftim SE, Haver CE, Vincent-Hall TD.   +11 more
europepmc   +1 more source

Cardiovascular and neuropsychiatric outcomes with PCSK9 inhibitors in atherosclerotic cardiovascular disease: A retrospective cohort study

British Journal of Clinical Pharmacology, EarlyView.
Study design and main findings. After 1:1 propensity score matching, 60 885 PCSK9 inhibitor users and 60 885 statin‐only users with ASCVD were compared. Kaplan–Meier curves show 12‐month cumulative event‐free survival for MACE, psychiatric disease, and neurodegenerative disease.
Tianshu Gu, Yang Chen, Nan Zhang, Uazman Alam, Riccardo Proietti, Tong Liu, Kang‐Yin Chen, Gregory Y. H. Lip   +7 more
wiley   +1 more source

Advancing systems thinking in implementation science: An epidemiologic perspective. [PDF]

Ann Epidemiol
Giovenco D, Filiatreau LM, Knox J, Mody A, Galea S, Marshall BDL, Wall KM, Sullivan PS.   +7 more
europepmc   +1 more source

Relationships among nitrous oxide exposure, neurological injury and biomarkers

British Journal of Clinical Pharmacology, EarlyView.
Aims Recreational nitrous oxide (N2O) misuse is an increasing public health problem associated with functional cobalamin (B12) deficiency and severe neurological complications. Despite growing recognition of its harms, the dose–response relationship and clinical value of biomarkers remain unclear.
Laxna Bhujel, Angela L. Chiew, Bhashita Jagarlamudi, Pramod Chandru, Naren Gunja, Nancy Briggs, Betty S. Chan   +6 more
wiley   +1 more source

Rethinking Maternal Obesity Research in a Changing Clinical Landscape. [PDF]

Paediatr Perinat Epidemiol
Hutcheon JA, Bodnar LM.
europepmc   +1 more source

Clozapine:norclozapine ratio as a marker of metabolic risk and therapeutic response and effect of valproate on clozapine levels

British Journal of Clinical Pharmacology, EarlyView.
Aims Clozapine is the most effective antipsychotic in treatment‐resistant schizophrenia. Clozapine causes weight gain and increased diabetes risk. The role of its metabolite norclozapine and clozapine:norclozapine ratio (CLZ/NCLZ) in metabolic effects has been debated.
Susanna Maria Rask, Miina Lamminmäki, Olli Kampman, Mari Hämäläinen, Eeva Moilanen, Niko Seppälä, Anssi Solismaa   +6 more
wiley   +1 more source