Improving the Efficiency of Clinical Pharmacology Studies

Polasek, Thomas M.; Schuck, Virna

doi:10.1002/cpdd.1274

Cited by 4 publications

(2 citation statements)

References 16 publications

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“…Additionally, challenges such as the need to meet regulatory requirements, potential toxicity of new chemicals, and the time-consuming development process significantly impact research efforts and costs (Conway, 1993;Michielan & Moro, 2010). Moreover, the shift towards studying more complex diseases, escalating clinical trial sizes and costs, and the late identification of failures during clinical studies contribute to the economic burden faced by pharmaceutical companies (Polasek & Schuck, 2023). Overall, these factors collectively drive up the expenses and extend the duration of pharmaceutical research endeavors, posing significant challenges to the industry.…”

Section: Addressing the High Cost And Lengthy Research Time In Pharma...mentioning

confidence: 99%

Computational Pharmaceutics: A Comprehensive Review of Past Achievements, Present Applications, and Future Challenges

Chaudhari,

Puri

et al. 2024

Preprint

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This paper explores the transformative impact of computational pharmaceutics, integrating AI, multi-scale modeling, quantum computing, AI-driven drug discovery, and blockchain frameworks. Molecular dynamics simulations provide insights into atomic behaviors crucial for drug design. Quantum computing reduces computational costs for simulating protein-drug interactions. AI and Graph Neural Networks accelerate drug discovery and personalized medicine. Blockchain frameworks facilitate secure pharmacogenetic data sharing. These advancements revolutionize drug development, offering unprecedented efficiency, innovation, and personalized treatments.

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Section: Addressing the High Cost And Lengthy Research Time In Pharma...mentioning

confidence: 99%

Computational Pharmaceutics: A Comprehensive Review of Past Achievements, Present Applications, and Future Challenges

Chaudhari,

Puri

et al. 2024

Preprint

View full text Add to dashboard Cite

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“…Phase 1 clinical studies are fundamental for the development of new drugs [ 2 ]. A defining feature of these studies is the participation of healthy volunteers (HVs) who, in principle, lack characteristics that disrupt on-study activities and negatively influence study results.…”

Section: Introductionmentioning

confidence: 99%

Personality vulnerabilities and adverse event reporting in phase 1 clinical studies

Skommer,

Gunesh,

Polasek

2024

Trials

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Background Phase 1 clinical trials involve rigorous safety monitoring to identify any adverse effects of investigational treatments. There is growing evidence that healthy volunteers recruited in these studies may differ with respect to personality traits from the general population. This, in turn, may have a significant impact on the reporting of adverse events, particularly in trials investigating psychoactive treatments, including the psychedelic substances. Main body This analysis stems from our combined experience as investigators in phase 1 clinical trials and conveys an experiential understanding of the impact of psychological heterogeneity on study participation, reporting of adverse events and study outcomes. Conclusion Participant variability due to psychological characteristics is regularly overlooked in phase 1 clinical trials and may significantly impact on reporting of the adverse events. In our opinion, healthy volunteers who present for these studies should not only be defined by the absence of past or current medical and psychiatric illness but also characterised by their psychological attributes.

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Commentary on Improving the Efficiency of Clinical Pharmacology Studies

Fossler

2023

Clinical Pharm in Drug Dev

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Improving the Efficiency of Clinical Pharmacology Studies

Cited by 4 publications

References 16 publications

Computational Pharmaceutics: A Comprehensive Review of Past Achievements, Present Applications, and Future Challenges

Computational Pharmaceutics: A Comprehensive Review of Past Achievements, Present Applications, and Future Challenges

Personality vulnerabilities and adverse event reporting in phase 1 clinical studies

Commentary on Improving the Efficiency of Clinical Pharmacology Studies

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