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Cloud Application in Drug Development
Published in Rishabha Malviya, Pramod Kumar Sharma, Sonali Sundram, Rajesh Kumar Dhanaraj, Balamurugan Balusamy, Bioinformatics Tools and Big Data Analytics for Patient Care, 2023
Nitu Singh, Urvashi Sharma, Deepika Bairagee, Neelam Jain
It may also include the step of obtaining regulatory approval with a new drug application to market the drug, as well as preclinical research on microorganisms and animals, as well as filing for regulatory status, such as an investigational new drug application with the US Food and Drug Administration (FDA) to begin human clinical trials. Animals are used to study the pharmacological and toxicological properties of the lead compounds. Many workshop attendees emphasise that efficacy studies, rather than safety tests, are often not necessary prior to first-in-human testing. Following the development of a lead medication, it undergoes further testing to optimise its physicochemical and pharmacological qualities, notably potency and selectivity. Optimization is a difficult, time-consuming, and costly procedure, despite the time, manpower, and financial resources spent on lead compound research [3,4]. Following optimization, a Phase Ia clinical research in which healthy volunteers are given a single dosage of the drug can begin. The next step is to performPhase Ib trials, which comprise a series of escalating doses to establish safety, steady-state pharmacokinetics, and the maximum tolerated dose. Proof of concept (POC) and effectiveness evidence are increasingly being sought in Phase Ib studies. A typical POC clinical trial consists of a small controlled study with less than 100 subjects/patients done at fewer than four locations. If the drug is shown to be safe and effective at POC, larger Phase II and Phase III studies with randomised, often placebo-controlled arms are done to ensure safety and effectiveness. After successfully completing Phase III and submitting a new drug application (NDA) to the FDA, a pharmaceutical becomes eligible for commercialization, as indicated in Table 10.1. Even after a drug has been licensed for use, post-marketing surveillance is conducted to ensure its safety [2]. From idea through preclinical testing in the lab to clinical trial development, including Phase I–III trials, to an authorised vaccine or drug, the complete process takes more than a decade [5]. To deliver safe and effective novel therapeutic compounds, the process of finding new active pharmaceutical ingredients (APIs) begins with target identification and validation and continues with hit identification, lead discovery, and lead optimization in the preclinical stage [6,7].
Multi-dimensional readiness assessment of medical devices
Published in Theoretical Issues in Ergonomics Science, 2023
Rosemary Ruiz Seva, Angela Li Sin Tan, Lourdes Marie Sequerra Tejero, Maria Lourdes Dorothy S. Salvacion
Readiness assessment using HRLs and TRLs does not go beyond the actual use of technology. In contrast, in MDD, post-marketing surveillance is part of the regulatory process for high-risk MDs. Device users, hospitals, and health professionals are required to inform regulatory bodies and device manufacturers of adverse events related to its use (Van Norman 2016). Post-marketing surveillance is necessary to ensure that the device is safe and works as intended.