What model(s) will you use for testing (i.e., animal, cell cultures, computer simulations)? Explain the choice of model, and provide support for the reliability of the model. Discuss the pros and cons of your choice.
Human cancer cells play an important role in drug testing as malignant cells involves and interacts with healthy cells in the body to complicate cancer treatment processes. Drug ZL105 will be tested using cell culture model as it is beneficial to investigating drug resistance and mechanistic processes in tumor cells. Therefore, culture model is reliable because it allows anticancer drug testing with Drug ZL105 and knowledge on epigenetics and genetic alterations. Through the application of cell culture and the two-dimensional monolayer conditions, the model can indicate response to cancer compounds or therapeutic such as in Drug ZL105 (Adcock et al., 2015). Cell culture models to test Drug ZL105 makes it possible to solve the complexity of neoplasms in developing resistance to chemotherapy. The model is crucial for precise selection of antitumor agents in the drug that are effective in the clinic and vivo conditions. Under the cell culture model, it becomes easier to predict the aggressiveness of the tumor behavior in the body as the cells migrate and invade (Kapałczyńska et al., 2018). The cell culture model also potentially and largely incorporates 3D printing which bio-prints fabric through high resolution to project the desired architecture and accurately determine the effect of Drug ZL105.
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The pros of the cell culture model include the easiness of manipulating and handling cell lines through the use of pharmacological cytostatic, expression vectors, demethylation agents, and siRNA (Fang & Eglen, 2017). Cell line also have a large similarity with initial tumor, immediately accessible, are in large numbers, have a variety, and are homogeneous hence there is a reproducibility of the outcomes of the Drug ZL105 test in correct conditions . As continuous cell lines, they have an unlimited auto replicative source with easy substitution of the cultures that were contaminated in frozen and respective frozen cell lines. Some cons include the heterogeneity of solid tumors making difficult to analyze to see Drug ZL105 effectiveness. Another disadvantage is the poor characterization of the large variety and number of cancer cell lines available with comes cells encountering cross contamination from HeLa cells (Fang & Eglen, 2017). Additionally, with genomic instability, it is possible to have differences between the cells lines and their respective original tumor. The culture conditions also can change the gene expression, morphology, and several cellular pathways resulting in inaccurate outcomes.
In determining the safety and effectiveness of the drug, would it be necessary to test efficacy, toxicity, and lethality? Explain what each of these tests are for and whether or not one or more of the tests are necessary for your determination.
Yes, it would be necessary to test the toxicity, lethality, and efficacy of Drug ZL105 to determine its effectiveness and safety. Testing the toxicity of Drug ZL105 is necessary more than one times to determine the level of damage that Drug ZL105s compound can cause to a person. This also means determining the toxic effects as dose dependent and how they affect specific organs or entire systems to cause urotoxicity, nephrotoxicity, hematopoietic suppression, cardiotoxicity, hemorrhagic cystitis, and gastrointestinal toxicity. Determining lethality of Drug ZL105 is important as it involves establishing the safe and reliable dosage to know the median lethal dose of the drug (Fang & Eglen, 2017). This is by monitoring the weight loss and clinical conditions as a result of dosage to see the deviation from normal as doses are escalated an incremental manner. Determining the efficacy of the Drug ZL105 is important as it involves reviewing the pharmaceutical literature to explore systematic reviews, evaluate randomized controlled trials, to ensure that the health practitioners offer unbiased information. Formulating the clinical question within efficacy specifies population margins, intervention processes, comparative treatment alternatives, and projected outcomes. This also involves getting clinical evidence, assessing the evidence’s quality, statistical analysis, and statistical tests to determine Drug ZL105 efficacy.
Provide your thoughts on what information you hope to gather from your tests and whether or not the same protocol should be used for various categories of products such as drugs, cosmetics, and herbal medicines.
The information to be gathered from the tests using Drug ZL105 include the ability of the drug to act as an angiogenesis inhibitor. During preclinical and clinical screening, Drug ZL105 information on Drug ZL105s degradation pathways, absorption, solubility, and stability in solution and solid states are information needed to explain the mechanisms of the drug activity (Adcock et al., 2015). It is also important to collect information on the ability of the drug in partaking in accurate selectivity towards target tissues without harming normal cells while having a significant cytotoxic activity towards tumor cells thereby causing tumor regression. Information on the toxicity, lethality, and efficacy of Drug ZL105 is important as it documents the toxicity of Drug ZL105 compound in affecting human organs. Information on lethality of the drug is important as documents the median lethal dose of the drug to promote safe use (Fang & Eglen, 2017). Information on the Drug ZL105s efficacy because it uses past knowledge on objective pharmaceutical literature to determines its potential benefits. Such data includes the clinical evidence, statistical tests and analysis, and quality assessment of evidence. The same protocol should be used for various categories of products such as drugs, cosmetics, and herbal medicines to determine their effectiveness, toxicity, and lethality.
References
Adcock, A. F., Trivedi, G., Edmondson, R., Spearman, C., & Yang, L. (2015). Three-Dimensional (3D) cell cultures in cell-based assays for in-vitro evaluation of anticancer drugs. Journal of Analytical & Bioanalytical Techniques , 6(3), 1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6040128/
Fang, Y., & Eglen, R. M. (2017). Three-dimensional cell cultures in drug discovery and development. Slas discovery: Advancing Life Sciences R&D , 22(5), 456-472. https://journals.sagepub.com/doi/full/10.1177/1087057117696795
Kapałczyńska, M., Kolenda, T., Przybyła, W., Zajączkowska, M., Teresiak, A., Filas, V., ... & Lamperska, K. (2018). 2D and 3D cell cultures–a comparison of different types of cancer cell cultures . Archives of Medical Science: AMS , 14(4), 910. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6040128/
