Results 191 to 200 of about 86,255 (232)

External Control Arms in Japan: A Systematic Case Analysis of Documented Regulatory Implementation and Uncertainty Management

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
External control arms (ECAs) have emerged as important tools to provide benchmark evidence on comparator effectiveness and thereby support regulatory decision making in situations where randomized controlled trials are difficult to conduct. However, how key methodological elements for ECAs are documented and implemented in practice and how residual ...
Suguru Okami, Alexandros Sagkriotis
wiley   +1 more source

Clinical Function Assignment of NAT2 Alleles by the Clinical Pharmacogenetics Implementation Consortium Pharmacogene Curation Expert Panel

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
NAT2 encodes arylamine N‐acetyltransferase 2, a key enzyme in the phase II metabolism of arylamines and arylhydrazines. NAT2 is highly polymorphic, resulting in variable distributions of rapid and poor metabolizers across global populations. Here, we detail the process undertaken by the Clinical Pharmacogenetics Implementation Consortium (CPIC) NAT2 ...
Bailey M. Tibben   +10 more
wiley   +1 more source

<i>In silico</i> prediction and IgE serum screening for potential allergenicity of novel foods-a case of fungal biomass Fermotein®. [PDF]

open access: yesFront Allergy
Versteeg SA   +7 more
europepmc   +1 more source

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