Comprehensive Report: The Pharmaceutical Drug Discovery Process

This report provides a detailed overview of the pharmaceutical drug discovery process, encompassing its various stages from initial research and development to post-market drug safety monitoring. It begins with an introduction to pharmaceutical medicine, emphasizing its role in disease tr...Read More

Running head: PHARMACEUTICAL DEVELOPMENT
PHARMACEUTICAL DEVELOPMENT
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Introduction
Pharmaceutical medicine is the branch which belong to medical discipline concerned
with the medical aspect of exploration, development, evaluation, registration, monitoring and
marketing of the medicine for wellbeing of the patients and for the benefit of the whole
community (Hughes et al. 2011). The discipline involves testing of the medicine, converting the
research of pharmaceutical drug into new medicine, ensuring safety of the participant in the
research trails, and evaluate medicine safety profile and the concerned benefit-risk of the
medicine. The pharmaceutical medicine is identified as a specialty of full medical since 2002
(Ramsundar et al. 2015). The discipline has given new insight to drug discovery and way of
treatment of deadly disease.
There are various function of drug discovery process which has been outline below:
1. Discovery and development process- The first function of drug discovery process is the
selection of molecule or target which is either genetic or cellular chemical in the body.
Such molecule should be involved in particular disease (Frye et al. 2015). The
combination of such molecule is called lead which have elements required for new
medicine. Next lead optimization is done that compare the features of the target molecule
which has high probability of success. This phase involves testing of the molecule which
is compatible of drug discovery.
2. Preclinical research- The second function of drug development process involves pre-
clinical testing which comprises of in-vitro and in-vivo testing. In-vivo testing the drug
molecules is tested in the animal species or in the cell cultures. In vitro testing involves
examination of the drug in test tube in lab. The research needs approval from FDA by

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showcasing the detail information on the dosing and toxicity level. Post-research, based
on finding further phase can move forward for test in human (Hughes et al. 2011). Hence,
there is the need to submit application on investigation of new drug to the FDA, if FDA
gives approval to drug developer IND, test in human can be initiated.
3. Clinical research- The clinical research are the trail which is done on human being based
on the result of pre-clinical test. The research has various phases:
Phase 1- This phase involves testing of drug in small group of healthy peoples where the
process of absorption and elimination of drug is studied to evaluate its side effects.
Phase 2- This phase involves testing drug in the more than 100 patients having disease in
question. The study evaluate the side effect and efficacy of drugs in diseased patients
considering the dose size of drug (Li et al. 2015).
Phase 3- The phase involves more patients where efficacy is drug is tested. The phase is
designed by developer of drug, which also needs approval by FDA with the guideline to
determine the positive and negative effect of the tested drug. If the end gives safety
assurance, next step is to file for its approval (Singh 2015).
4. FDA review- The application is review by the FDA to check its authenticity. During the
phase, each specific member evaluate the study based on their discipline. The FDA
inspector move to site to conduct inspection of study. The project manager gather all the
reviews and document the finding. These document are the record for review of FDA
where team issue suggestions and send to senior FDA to make firm decision (Gawehn,
Hiss and Schneider 2016).
5. Drug safety monitoring- Even though clinical trial gives relevant information about the
drug efficacy, report of counter drugs, dosage and usage information can be reviewed by

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the FDA. FDA develops a system to detect the safety issue related to drugs with the help
of health database like electronic health record systems.
Difference between in regulatory strategy and plan:
For development of drug, its needs regulatory approval to get license for the drug.
Regulatory strategy involves those action which is constructed to achieve approval for the new
drugs. It gives authorized credential to launch drug in the market with quality marketing plan.
Regulatory plan gives information about the regulatory amendments to determine business
regulation (elementary legislation) of the drugs. Thus, it is the document which designate each
phase and action which is required for regulatory strategies and its goal (Gammie, Lu and Babar
2015).
Conclusion
Lastly, from the above discussion it can be concluded that, pharmaceutical medicine is
one of the boon of health sector which has given new insight for disease treatment through
discovery of drugs and medicines. Though the drug discovery process is a lengthy process but
need to be done in safety. Clinical pharmacologist is the responsible body for collection of
pharmacokinetic data and to make plan, design clinical trial and meet FDA approval. For release
of drug the researcher ensures appropriate licensing, legal amenability of the pharmaceuticals
and marketing. It is done to control the safety and efficacy of the drug. Thus, each of the step of
drug discovery process need keen monitoring and guidance.

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Reference
Frye, S.V., Arkin, M.R., Arrowsmith, C.H., Conn, P.J., Glicksman, M.A., Hull-Ryde, E.A. and
Slusher, B.S., 2015. Tackling reproducibility in academic preclinical drug discovery. Nature
Reviews Drug Discovery, 14(11), p.733.
Gammie, T., Lu, C.Y. and Babar, Z.U.D., 2015. Access to orphan drugs: a comprehensive
review of legislations, regulations and policies in 35 countries. PloS one, 10(10), p.e0140002.
Gawehn, E., Hiss, J.A. and Schneider, G., 2016. Deep learning in drug discovery. Molecular
informatics, 35(1), pp.3-14.
Hughes, J.P., Rees, S., Kalindjian, S.B. and Philpott, K.L., 2011. Principles of early drug
discovery. British journal of pharmacology, 162(6), pp.1239-1249.
Li, E.C., Abbas, R., Jacobs, I.A. and Yin, D., 2015. Considerations in the early development of
biosimilar products. Drug discovery today, 20, pp.1-9.
Ramsundar, B., Kearnes, S., Riley, P., Webster, D., Konerding, D. and Pande, V., 2015.
Massively multitask networks for drug discovery. arXiv preprint arXiv:1502.02072.
Singh, J., 2015. International conference on harmonization of technical requirements for
registration of pharmaceuticals for human use. Journal of pharmacology &
pharmacotherapeutics, 6(3), p.185.