Adaptive Designs: Lessons for Inflammatory Bowel Disease Trials

D’Amico, Ferdinando; Danese, Silvio; Peyrin–Biroulet, Laurent

doi:10.3390/jcm9082350

Cited by 3 publications

(3 citation statements)

References 30 publications

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“…Clinical trial phases are regarded as long and extensive periods that take years from the point of research to the stage of approval of a candidate drug. Prior to these trials, detailed protocols that show the characteristics of the studies are provided[ 76 ]. The clinical phase comes after certainty has been established that the drugs/molecules are effective and non-toxic.…”

Section: Ibd Drug Discovery and Developmentmentioning

confidence: 99%

“…The phase I is the stage in drug development when testing and pharmacokinetics studies are carried out using healthy or ill subjects[ 76 ] to ascertain safety level of the drugs. The pharmacokinetics and pharmacodynamics of the drugs are determined using volunteer patients or patients who are not responsive to previous treatments in order to determine drug safety alongside desired clinical activities and an Absorption, Digestion, Metabolism and Excretion (ADME) profile[ 68 ].…”

Section: Ibd Drug Discovery and Developmentmentioning

confidence: 99%

“…The phase II is the stage that involves dose ranging. The efficacy of the drugs are determined alongside the optimum dose that would be considered safe[ 76 ]. At the point of dose determination, the outcome of the effect of different doses would guide the decision to proceed to the next phase.…”

Section: Ibd Drug Discovery and Developmentmentioning

confidence: 99%

See 2 more Smart Citations

Modern drug discovery for inflammatory bowel disease: The role of computational methods

Johnson¹,

Akinsanmi²,

Ejembi³

et al. 2023

World J Gastroenterol

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Inflammatory bowel diseases (IBDs) comprising ulcerative colitis, Crohn’s disease and microscopic colitis are characterized by chronic inflammation of the gastrointestinal tract. IBD has spread around the world and is becoming more prevalent at an alarming rate in developing countries whose societies have become more westernized. Cell therapy, intestinal microecology, apheresis therapy, exosome therapy and small molecules are emerging therapeutic options for IBD. Currently, it is thought that low-molecular-mass substances with good oral bio-availability and the ability to permeate the cell membrane to regulate the action of elements of the inflammatory signaling pathway are effective therapeutic options for the treatment of IBD. Several small molecule inhibitors are being developed as a promising alternative for IBD therapy. The use of highly efficient and time-saving techniques, such as computational methods, is still a viable option for the development of these small molecule drugs. The computer-aided ( in silico ) discovery approach is one drug development technique that has mostly proven efficacy. Computational approaches when combined with traditional drug development methodology dramatically boost the likelihood of drug discovery in a sustainable and cost-effective manner. This review focuses on the modern drug discovery approaches for the design of novel IBD drugs with an emphasis on the role of computational methods. Some computational approaches to IBD genomic studies, target identification, and virtual screening for the discovery of new drugs and in the repurposing of existing drugs are discussed.

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Section: Ibd Drug Discovery and Developmentmentioning

confidence: 99%

Section: Ibd Drug Discovery and Developmentmentioning

confidence: 99%