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The Role of Bioinformatics Tools and Technologies in Clinical Trials
Published in Rishabha Malviya, Pramod Kumar Sharma, Sonali Sundram, Rajesh Kumar Dhanaraj, Balamurugan Balusamy, Bioinformatics Tools and Big Data Analytics for Patient Care, 2023
Sandesh Varshney, Manisha Bharti, Sonali Sundram, Rishabha Malviya, Neeraj Kumar Fuloria
One of the most important areas of clinical research is clinical trials. A medical study is a scientific effort that tests whether a new healthcare therapy or a new way of employing an existing medication is better in terms of preventing, diagnosing, or treating a disease. Pre-clinical tests must be passed before a novel medicine may join a clinical trial. In vitro experiments and preliminary meta-analyses are examples of biomedical models. To obtain primer viability, toxicity, and pharmacokinetic data, a wide range of measures of the examined medication needs to be supplied to animal participants or invitro substrates [10]. Before the initiation of the clinical trial, it must pass the approval stage of the FDA, which involves a preclinical investigation. There are five phases in the clinical trials: Stage 0, Stage I, Stage II, Stage III, and Stage IV. They are elaborated below.
Product Development in Biotechnology
Published in Firdos Alam Khan, Biotechnology Fundamentals, 2020
Once a drug has completed preclinical trials with a great success rate, the drug molecule is now ready for testing in humans, starting with normal and healthy individuals, to check the toxicity or side effects of the drug molecule. If the drug does not show any apparent toxicity or side effects, it may now be tested in patients suffering from specific disease conditions. There are four phases of clinical trials: Phase I, Phase II, Phase III, and Phase IV. All these phases are conducted in specialized and FDA-approved clinical centers and hospitals. In healthcare, clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety. Health authority or ethics committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients in small pilot studies initially, followed by larger-scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.
Preclinical Models for Pulmonary Drug Delivery
Published in Anthony J. Hickey, Sandro R.P. da Rocha, Pharmaceutical Inhalation Aerosol Technology, 2019
Jibriil P. Ibrahim, Robert J. Bischof, Michelle P. McIntosh
Finally, and most importantly, the selection and use of animals for preclinical studies must be based on sound ethical considerations. Many articles have discussed the ethical use of animals in medical research. We direct the reader to recent articles that investigate the validation and suitability of animal models for preclinical studies (Varga et al. 2010) and the ethical and regulatory considerations in animal studies (Carbone 2011). Importantly, the ethical use of animals extends beyond individual animal welfare and includes the number of animals used for trials. This can be evaluated during the study design and in collaboration with biostatisticians to evaluate proposed statistical methods and determine the number of animals required for the proposed study (Aban and George 2015).
Melatonin therapy for blunt trauma and strenuous exercise: A mechanism involving cytokines, NFκB, Akt, MAFBX and MURF-1
Published in Journal of Sports Sciences, 2018
Gerald J. Maarman, Russel J. Reiter
The majority of data regarding the proposed mechanism of melatonin have been generated in animal models of muscle injury. Animal models are widely used as preclinical models for the investigation of underlying mechanisms of a variety of human diseases (Ascherman, 2012; Maarman, 2017; Ytterberg, 1991). Similarly, the animal studies discussed in this paper provide valuable information about the role of melatonin in possibly limiting muscle injury. Preclinical models cannot substitute clinical evidence and animal data is not always translatable to the clinical setting. However, it can aid in the development/design of clinical studies on melatonin and muscle injury. Clinical trials are therefore necessary to provide clinically relevant data that would be useful to the athlete. These trials could test the efficacy of melatonin, administered via several routes, in humans with muscle injury, particularly given that melatonin is safe with no serious toxicities (Andersen, Gogenur, Rosenberg, & Reiter, 2016). It is worth mentioning however, that melatonin’s tendency to cause drowsiness may impede sports performance, as reviewed by Atkinson, Drust, Reilly, and Waterhouse (2003). These authors provided an in-depth discussion of all the studies where melatonin impaired sports performance when administered during daytime or during practice. Rather, melatonin should be considered as a treatment during post-injury recovery, where rest is routinely prescribed (Baoge et al., 2012; Chazaud, 2016).
Modulating effect of DL-kavain on the mutagenicity and carcinogenicity induced by doxorubicin in Drosophila melanogaster
Published in Journal of Toxicology and Environmental Health, Part A, 2021
Thaís Teixeira da Silva, Júlia Braga Martins, Maria Do Socorro de Brito Lopes, Pedro Marcos de Almeida, José Luiz Silva Sá, Francielle Alline Martins
Conducting preclinical studies, in vitro and in vivo assays, help to assess the effectiveness and toxicity of a potential “drug” prior to human exposure (Bale et al. 2014; Mattes 2020; Pandey and Nichols 2011). The extensive knowledge regarding the genetic structure, biological development and high similarity for the genes identified in human diseases, make D. melanogaster useful in toxicological genetics research (Alaraby et al. 2016; Baldridge et al. 2021; Ertuğrul et al. 2019). The evolutionary conservation of tumor suppressor genes among Drosophila and mammals has prompted studies of tumor induction in Drosophila, which contributes to the understanding of cancer in humans (Mirzoyan et al. 2019).
Scheduling and control of high throughput screening systems with uncertainties and disturbances
Published in Production & Manufacturing Research, 2022
Adetola Oke, Laurent Hardouin, Xin Chen, Ying Shang
A successful drug discovery is an extremely time-consuming procedure, including initial target identification and validation, pre-clinical trials on animals, regulatory approval to start trials in humans, clinical trials, submission of marketing and manufacturing authorization, licensing review, product sale, and post-marketing surveillance (Major, 1998; Mayer et al., 2008; Mayr & Fuerst, 2008; Noah, 2010; Pereira & Williams, 2007). With the development of robotics and high-speed computing technology, it is feasible to develop automatic systems that can screen a large number of biochemical compounds in a short period. Such an automatic compound screening and analyzing process is called high-throughput screening (HTS) in drug discovery of pharmaceutical industries. HTS is a standard technology routinely employed in the pharmaceutical industry for drug discovery processes. It is used for initial screening in the process of drug discovery to reduce what is an almost infinite number of possible combinations of compounds to a reasonably few enough possibilities on which further testing can be carried out. Many HTS systems consist of several activities on several different resources. An HTS operation can incorporate multiple batches, each with hundreds of events, where a batch is a combination of all the operations to be performed on a set of substances for complete analysis. HTS provides a practical and efficient method to test a large number of synthetic compounds in miniaturized in vitro assays to identify hit targets of interest. Then, the chemical compounds that have therapeutic and useful pharmacological or biological activities, called leads, are evaluated and undergo lead optimization to identify promising lead compounds. Followed by the initial synthesis and animal testing in preclinical trials and three phases of clinical trials on humans, a drug can be put on the market after the Food and Drug Administration (FDA) approval.