Zobrazeno 1 - 10
of 65
pro vyhledávání: '"D. Breder"'
Autor:
Christopher D. Breder
Publikováno v:
BMC Medical Research Methodology, Vol 18, Iss 1, Pp 1-8 (2018)
Abstract Background Interpreting graphs of continuous safety variables can be complicated because differences in age, gender, and testing site methodologies data may give rise to multiple reference limits. Furthermore, data below the lower limit of n
Externí odkaz:
https://doaj.org/article/6d050bd3e3d34b05afc96db55b92b507
Publikováno v:
Clinical Pharmacology & Therapeutics. 110:1381-1388
Immunogenicity, the potential to elicit an antidrug immune response, is a critical concern in developing biological products, but its consequences are difficult to predict with animal studies. The aims of the present study are to investigate the evol
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fc3256d5909b71d3c207e3ab21e7379b
https://doi.org/10.1002/cpt.2393
https://doi.org/10.1002/cpt.2393
Publikováno v:
PLoS ONE, Vol 12, Iss 6, p e0178104 (2017)
Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to
Externí odkaz:
https://doaj.org/article/7850356229bb4cff835c941e5ad5bd2d
Autor:
Mark Robberson, Christopher D. Breder
Publikováno v:
Therapeutic Innovation & Regulatory Science. 55:262-269
The pace of innovation, the creative engine of the pharmaceutical industry, has been variably described as stagnant, stable, or accelerating depending on the metric used for assessment or the quality of evidence. If the predominant perception holds t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::beee5a4277e8328209060ea5002ea187
https://doi.org/10.1007/s43441-020-00210-7
https://doi.org/10.1007/s43441-020-00210-7
Publikováno v:
Pharmacological Research. 139:166-172
The aims of this study were to identify types of deficiencies resulting in delay of approvals for drugs eventually approved by the US FDA and to search for factors associated with higher first-cycle approval rates. Review documents of New Drug Applic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c08bc559d5091246f1bdd7d618e766e4
https://doi.org/10.1016/j.phrs.2018.11.004
https://doi.org/10.1016/j.phrs.2018.11.004
Publikováno v:
Drug discovery today. 24(9)
The drug development cycle is classically divided into a clinical phase and review phase, with the clinical phase typically being further partitioned based on the planning and conduct of adequate and well controlled trials. Factors affecting the dura
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::243b81d9d7ab8508c08cdf16d79593f9
https://pubmed.ncbi.nlm.nih.gov/31170505
https://pubmed.ncbi.nlm.nih.gov/31170505
Autor:
Carolyn Tieu, Christopher D. Breder
Publikováno v:
Drug safety. 41(12)
Algorithmic Standardised MedDRA® Queries (aSMQs) are increasingly used to enhance the efficiency of safety signal detection. The manner that aSMQs affect capture of potential safety cases is unclear. Our objective was to characterise the performance
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fa9f52f244df8e2c0363c5b2401d5227
https://pubmed.ncbi.nlm.nih.gov/30112728
https://pubmed.ncbi.nlm.nih.gov/30112728
Publikováno v:
Clinical therapeutics. 40(1)
Purpose Biological drug products, or products derived from living cells, represent an increasingly important part of the pharmaceutical market. Despite this, little is known about how sponsors determine the dose to be studied in registrational trials
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1ea70ab9e992e75ea4221c4a678193ec
https://pubmed.ncbi.nlm.nih.gov/29273471
https://pubmed.ncbi.nlm.nih.gov/29273471
Publikováno v:
Trends in biotechnology. 35(7)
Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0a8d5ebd158e8a884460d317c5843a3e
https://pubmed.ncbi.nlm.nih.gov/28391988
https://pubmed.ncbi.nlm.nih.gov/28391988
Autor:
Christopher D. Breder
Standardized MedDRA Queries (SMQs) are sets of terms determined by experts that are used to identify adverse events (AEs) related to different disease processes. Their use can be challenging because most SMQs have 50 to 100 preferred terms and AE dat
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9aca2d4845f7fd84b6f330d72d329380
https://europepmc.org/articles/PMC4886503/
https://europepmc.org/articles/PMC4886503/
