Mark Holbrook
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View article: Predicting clinical outcomes from off-target receptor interactions using Secondary Intelligence™
Predicting clinical outcomes from off-target receptor interactions using Secondary Intelligence™ Open
Adverse effects due to off-target activity can be predicted by careful comparison of the relationship between expected plasma concentration and off-target activity of the test compound with that of reference drugs targeting that receptor f…
View article: Review and Assessment of NGNP PIRTs for TRISO and HTGR Technologies
Review and Assessment of NGNP PIRTs for TRISO and HTGR Technologies Open
The main objective of this technical report is to ensure that research and development (R&D) needs are identified to address the significant (highly ranked) technical challenges related to TRISO-coated particle fuel, high-temperature gas-r…
View article: Utilization of mechanistic modelling and simulation to analyse fenspiride proarrhythmic potency – Role of physiological and other non‐drug related parameters
Utilization of mechanistic modelling and simulation to analyse fenspiride proarrhythmic potency – Role of physiological and other non‐drug related parameters Open
It can be hypothesized that the clinically observed arrhythmia cases were not directly caused by fenspiride alone but a combination of multiple factors, including comedications.
View article: Strategies to encourage the adoption of social housing during cardiovascular telemetry recordings in non-rodents
Strategies to encourage the adoption of social housing during cardiovascular telemetry recordings in non-rodents Open
The National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) is working with industry to promote social housing during cardiovascular telemetry recordings within non-rodent safety pharmacology and toxico…
View article: Applying the CiPA approach to evaluate cardiac proarrhythmia risk of some antimalarials used off‐label in the first wave of COVID‐19
Applying the CiPA approach to evaluate cardiac proarrhythmia risk of some antimalarials used off‐label in the first wave of COVID‐19 Open
We applied a set of in silico and in vitro assays, compliant with the Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm, to assess the risk of chloroquine (CLQ) or hydroxychloroquine (OH‐CLQ)‐mediated QT prolongation and Torsades …
View article: Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation
Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation Open
An international expert working group representing 37 organisations (pharmaceutical/biotechnology companies, contract research organisations, academic institutions and regulatory bodies) collaborated in a data sharing exercise to evaluate …
View article: General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA <i>In Silico</i> Strategy
General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA <i>In Silico</i> Strategy Open
This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/…
View article: Current Challenges, Constraints and Recommendations for Reducing Cost of Physical Security at US Commercial Nuclear Power Plants
Current Challenges, Constraints and Recommendations for Reducing Cost of Physical Security at US Commercial Nuclear Power Plants Open
Economic or financial causes have led to closure or announced early retirement of several US nuclear reactors in the last five years. The published report "Economic and Market Challenges Facing the U.S. Nuclear Commercial Fleet – Cost and …
View article: Regulatory and Licensing Strategy for Microreactor Technology
Regulatory and Licensing Strategy for Microreactor Technology Open
With electricity demand on the rise, an increase in the use of nuclear energy is needed in order to meet future energy demands. The use of nuclear energy will not only begin to positively address this demand, but will also mitigate the neg…
View article: NRC ARDC Guidance Support Status Report
NRC ARDC Guidance Support Status Report Open
This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17I…
View article: Proposed Advanced Reactor Adaptation of the Standard Review Plan NUREG-0800 Chapter 4 (Reactor) for Sodium-Cooled Fast Reactors and Modular High-Temperature Gas-Cooled Reactors
Proposed Advanced Reactor Adaptation of the Standard Review Plan NUREG-0800 Chapter 4 (Reactor) for Sodium-Cooled Fast Reactors and Modular High-Temperature Gas-Cooled Reactors Open
This report proposes adaptation of the previous regulatory gap analysis in Chapter 4 (Reactor) of NUREG 0800, Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR [Light Water Reactor] Edition.…
View article: Proposed Adaptation of the Standard Review Plan NUREG-0800, Chapter 4 (Reactor) for Sodium-Cooled Fast Reactors and Modular High-Temperature Gas-Cooled Reactors
Proposed Adaptation of the Standard Review Plan NUREG-0800, Chapter 4 (Reactor) for Sodium-Cooled Fast Reactors and Modular High-Temperature Gas-Cooled Reactors Open
This report provides a proposed adaptation of a previous regulatory gap analysis of Chapter 4 (Reactor) of NUREG-0800 , Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR [Light Water Reactor…