BOS 4201 Toxicology: Drug ZL105 Testing Methods and Safety Assessment

This report provides a comprehensive overview of drug testing methodologies, focusing on the experimental drug Drug ZL105. The author explores the use of computer simulation and cell culture as primary and secondary testing methods, respectively, emphasizing their advantages over traditional animal testing. The report delves into the critical aspects of drug evaluation, including efficacy, toxicity, and lethality, and how these factors contribute to determining a drug's safety and effectiveness. The discussion highlights the importance of both clinical and non-clinical studies in drug development, emphasizing the role of dose-response curves and the potential for these techniques to be applied in other areas such as cosmetics and herbal medicines. The report also references relevant literature to support the discussion.

Safety is a major concern before certifying a drug as a medicine. Scientists and researchers
had to make sure that in the medication process, the drugs would not create any adverse
effect on the human body. That is why before coming to the market as medicine, a drug has
to go through a series of quality tests in order to detect side effects and possible risks. The
experimental drug which has derived from Iridium and has a high potential to be used against
cancer also needs to be tested before accepting it as a medicine. There are many techniques
available in order to taste a drug. The most primitive technique is animal testing. Animals
like rats, rabbits, dogs, Gini pigs have a similar internal body structure like humans and for
that reason, animal testing is a widely accepted method in drug testing (Greek, 2013). Cell
culture model is a rapidly emerging technique for drug testing and it is mostly used in
anticancer drug discovery. Cell culture is a technique where cells are grown and nurtured
under strictly controlled conditions, normally out from their natural environment. And then
certain drugs are applied to those cells to correctly observe their behavior (Lynn, 2009).
Computer simulation process is a recent but very productive method of drug testing. In the
computer simulation process, the effects of drugs are tested on ‘virtual humans’, made
through computer simulations ("Computer simulations move step closer to reducing animal
use in drug testing | University of Oxford", 2018). While choosing the right method for
testing the experimental drug named Drug ZL105, I first assessed all three above mentioned
methods. While Animal testing has an accuracy rate of 75% to 85%, computer simulation has
a better accuracy rate from 89% to 96% ("Why computer simulations should replace animal
testing for heart drugs", 2018). Besides that, ethically I don’t support Animal testing because
lakhs of Animals get killed in this process, and human relevant computer models have better
accuracy than animal testing. Based on these facts, I have decided to use the computer
simulation method as primary and cell culture method as secondary to check the effectiveness
and side effects of Drug ZL105. I have chosen two methods to increase my accuracy level.

In the process of determining the safety and effectiveness of the Drug ZL105, it is very
important to test efficacy, toxicity, and lethality. In the context of healthcare and drug testing,
the term ‘efficacy’ means the ability of a drug to deliver favorable and positive effect.
Through efficacy, we come to know about the optimum advantage and response that can be
accomplished by a drug (Mandal, 2019). Toxicity reflects the toxic level of a drug that means
how toxic the drug can be, and what are the toxic effects it possesses when applied to a
human body (Schimelpfening, 2019). The idea of synthetic lethality first coined by Calvin
Bridges in 1922. It means how much cells are negatively affected of getting dead by the
implication of a certain drug in the human body. Through collecting large scale ‘omics' data,
lethality helps us to differentiate between normal and cancer cells. It targets cancer cells in a
calculative way and has the efficiency to reduce side effects and drug resistance (Gao & Lai,
2018). In order to determine the effectiveness of Drug ZL105, as per my consideration, all
these methods are very essential. Through the thorough examination of these methods, we
can get a clear idea about the usefulness of Drug ZL105. The drug development process is a
collaboration of both clinical and non-clinical studies. While computer simulation and cell
culture fulfill the non-clinical part, efficacy, toxicity, and lethality tests are the clinical
examinations that determine the effectiveness of a drug (Andrade et al., 2016).
From the results of these tests, we can get a lot of valuable information regarding Drug
ZL105. It helps us to get the dose-response curve for ZL105, ensures safety in for use as
medicine, and measures the toxic effects in human body. The learnings from these studies
help us to explain various interpretations in the population, open scope for new research and
investigations as well (David & Chinedu, 2018). These clinical and non-clinical tests
determine the dosage of a drug, procedure to consume the drug as medicine, and removes the
negative effects of the drug (Andrade et al., 2016). Apart from drug testing, I think we can
utilize these techniques in many other areas effectively. These methods can also be very

helpful in the case of preparing cosmetics and herbal medicines. Cosmetics are prepared from
many natural and chemical substances and come in direct contact with our bodies. Herbal
medicines are also a form of drug. So, in these cases, before releasing an herbal medicine or a
cosmetic product into the market, we first need to know its adverse effects and effectiveness.
And these tests are the only scientific way through which we can measure the effectiveness of
those products.

References:
Andrade, E., Bento, A., Cavalli, J., Oliveira, S., Schwanke, R., & Siqueira, J. et al. (2016).
Non-clinical studies in the process of new drug development - Part II: Good
laboratory practice, metabolism, pharmacokinetics, safety and dose translation to
clinical studies. Brazilian Journal Of Medical And Biological Research, 49(12). doi:
10.1590/1414-431x20165646
Computer simulations move step closer to reducing animal use in drug testing | University of
Oxford. (2018). Retrieved 9 October 2019, from http://www.ox.ac.uk/news/2018-03-
12-computer- simulations-move-step-closer- reducing-animal-use-drug-testing
David, A., & Chinedu, E. (2018). The importance of toxicity testing. Journal Of
Pharmaceutical And Biosciences. Retrieved from
https://www.researchgate.net/publication/328234149_The_importance_of_toxicity_te
sting
Gao, S., & Lai, L. (2018). Synthetic lethality in drug development: the dawn is
coming. Future Medicinal Chemistry, 10(18), 2129-2132. doi: 10.4155/fmc-
2018-0227
Greek, R. (2013). Animal Models in Drug Development. New Insights Into Toxicity And
Drug Testing. doi: 10.5772/53893
Lynn, D. (2009). Cell Culture. Encyclopedia Of Insects, 144-145. doi: 10.1016/b978-0-12-
374144-8.00048-5
Mandal, D. (2019). What Does Efficacy Mean?. Retrieved 9 October 2019, from
https://www.news- medical.net/health/What-Does-Efficacy-Mean.aspx

Schimelpfening, N. (2019). Signs and Symptoms to Watch for With Drug Toxicity. Retrieved
9 October 2019, from https://www.verywellmind.com/toxicity-meaning-and-
signs-and-symptoms-1067226
Why computer simulations should replace animal testing for heart drugs. (2018). Retrieved 9
October 2019, from https://theconversation.com/why-computer-simulations-
should-replace-animal-testing-for-heart-drugs-93409