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Article
Open AccessCorrection: Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies
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Open AccessGroup-by-Treatment Interaction Effects in Comparative Bioavailability Studies
Comparative bioavailability studies often involve multiple groups of subjects for a variety of reasons, such as clinical capacity limitations. This raises questions about the validity of pooling data from thes...
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Article
A genome-wide view of disordered proteins
Transcription factors containing disordered regions can now be mapped across the genome, aiding functional studies.
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Article
Open AccessA systematic review of the development and application of home cage monitoring in laboratory mice and rats
Traditionally, in biomedical animal research, laboratory rodents are individually examined in test apparatuses outside of their home cages at selected time points. However, the outcome of such tests can be inf...
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Article
Open AccessDefining the condensate landscape of fusion oncoproteins
Fusion oncoproteins (FOs) arise from chromosomal translocations in ~17% of cancers and are often oncogenic drivers. Although some FOs can promote oncogenesis by undergoing liquid-liquid phase separation (LLPS)...
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Article
Open AccessBioequivalence of Intravenous Alteplase from Two Different Manufacturing Processes in Healthy Male Volunteers: Results from a Two-Stage, Adaptive-Design Study
Alteplase is a recombinant tissue plasminogen activator used for thrombolytic treatment in several indications and is currently approved in Europe under the brand name Actilyse®. The current manufacturing process...
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Article
Open AccessSwitching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial
BI 695501 is an FDA-approved biosimilar to adalimumab reference product (RP). VOLTAIRE-X was a randomized clinical trial to assess outcomes with a biosimilar monoclonal antibody in line with the FDA requiremen...
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Article
Open AccessIdentification of long non-coding RNAs and RNA binding proteins in breast cancer subtypes
Breast cancer is a heterogeneous disease classified into four main subtypes with different clinical outcomes, such as patient survival, prognosis, and relapse. Current genetic tests for the differential diagno...
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Article
A community effort to bring structure to disorder
With protein structure prediction recently getting a seismic boost in accuracy, hopes are also up to better predict unstructured protein regions that can adopt diverse conformations. CAID, a community effort t...
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Article
Open AccessMolecular relaxation effects on vibrational water vapor photoacoustic spectroscopy in air
Photoacoustic spectroscopy is a highly sensitive technique, well suited for and used in applications targeting the accurate measurement of water vapor in a wide range of concentrations. This work demonstrates ...
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Open AccessSimilar Pharmacokinetics of the Adalimumab (Humira®) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE®-AI and VOLTAIRE®-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials
BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira®. We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 69550...
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Article
Open AccessCell-specific proteome analyses of human bone marrow reveal molecular features of age-dependent functional decline
Diminishing potential to replace damaged tissues is a hallmark for ageing of somatic stem cells, but the mechanisms remain elusive. Here, we present proteome-wide atlases of age-associated alterations in human...
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Article
A comparison of group sequential and fixed sample size designs for bioequivalence trials with highly variable drugs
A drug is defined as highly variable if its intra-individual coefficient of variation (CV) is greater than or equal to 30%. In such a case, bioequivalence may be assessed by means of methods that take the (hig...
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Open AccessEffect of Age and Renal Function on Idarucizumab Pharmacokinetics and Idarucizumab-Mediated Reversal of Dabigatran Anticoagulant Activity in a Randomized, Double-Blind, Crossover Phase Ib Study
Idarucizumab is an antibody fragment that specifically reverses dabigatran-mediated anticoagulation. Safety, pharmacokinetics and pharmacodynamics of idarucizumab were investigated in dabigatran-treated, middl...
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Article
Dynamical Locality of the Free Maxwell Field
The extent to which the non-interacting and source-free Maxwell field obeys the condition of dynamical locality is determined in various formulations. Starting from contractible globally hyperbolic spacetimes,...
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Article
Quantization of Maxwell’s Equations on Curved Backgrounds and General Local Covariance
We develop a quantization scheme for Maxwell’s equations without source on an arbitrary oriented four-dimensional globally hyperbolic spacetime. The field strength tensor is the key dynamical object and it is ...
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Protocol
Methods to Reconstruct and Compare Transcriptional Regulatory Networks
The availability of completely sequenced genomes and the wealth of literature on gene regulation have enabled researchers to model the transcriptional regulation system of some organisms in the form of a netwo...
