Drug Development & Research©

4 (15) 2023: 001-005 • Review Article

Drug development: stages, challenges, and importance

AUTHORS’ CONTRIBUTION: (A) Study Design · (B) Data Collection . (C) INTRODUCTION
Statistical Analysis · (D) Data Interpretation · (E) Manuscript Preparation
· (F) Literature Search · (G) No Fund Collection Drug development is a lengthy and complex process that
involves numerous stages and requires the collaboration of
This article discusses the process of drug development, which involves
scientists, researchers, and regulatory bodies. The goal of
ABSTRACT

identifying potential drug targets, developing new molecules, and drug development is to create safe and effective treatments
conducting preclinical and clinical trials to determine the drug's for various diseases and conditions that can improve patient
safety and efficacy. The article also highlights the challenges in drug
development, such as finding promising drug targets and ensuring that outcomes and quality of life. In this article, we will discuss
drugs are safe and effective for all patients. Despite these challenges, the key stages of drug development and the challenges that
drug development is crucial for improving patient outcomes and quality
of life, and understanding the process can help support the development come with each stage. The first stage of drug development
of safe and effective drugs. is the discovery phase, where scientists identify potential
Keywords: Drug development; Drug targets; Preclinical research; drug targets and develop new molecules that can interact
Clinical trials; Regulatory approval; Safety; efficacy; Challenges
with those targets. This stage involves extensive research
in various fields, including chemistry, pharmacology, and
biochemistry. Researchers use a range of techniques, such
as computer modelling and high-throughput screening, to
identify and validate potential drug candidates [1].
Once a promising compound is identified, it undergoes
preclinical testing, which involves testing its safety and
efficacy in animal models. This stage aims to determine the
compound's pharmacokinetics (how the body processes
and absorbs the drug) and pharmacodynamics (how the
drug interacts with the body's cells and tissues). Preclinical
testing also helps researchers understand the potential side
effects and toxicity of the drug [2].
If a compound passes preclinical testing, it moves to the
clinical trial stage, where it undergoes testing in human
subjects. Clinical trials are the most critical stage of drug
development, as they provide essential data on the drug's
safety and effectiveness in humans. Clinical trials are
conducted in three phases: Phase I: This stage involves
testing the drug's safety and tolerability in a small group
of healthy volunteers. The goal is to determine the optimal
dose and identify any potential side effects. Phase II: In
this stage, the drug is tested on a larger group of patients
with the condition the drug is intended to treat. The goal
is to determine the drug's efficacy, safety, and optimal
dosing. Phase III: This stage involves testing the drug on a
much larger group of patients, often across multiple sites.
The goal is to confirm the drug's safety and efficacy and to
Address for correspondence:
identify any rare or severe side effects [3].
If a drug passes all three phases of clinical trials, the developer
Tiffanee Lucia, submits a New Drug Application (NDA) to the regulatory
Pharmaceutical Sciences, Pfizer Global R&D, Sandwich, Kent, UK
E-mail: tiffanee.lucia@pfizer.com agency, such as the Food and Drug Administration (FDA)
in the United States. The NDA includes all the data and
information collected during the drug development
Word count: 1399 Tables: 00 Figures: 00 References: 10
process, including preclinical and clinical trial data,
manufacturing processes, and proposed labeling. The
Received: 01.04.2023, Manuscript No. ijddr-23-13666; Editor assigned: regulatory agency reviews the NDA and decides whether
04.04.2023, PreQC No. P-13666; Reviewed: 18.04.2023, QC No. to approve the drug for marketing. The agency considers
Q-13666; Revised: 21.04.2023, Manuscript No. R-13666; Published:
28.04.2023 factors such as the drug's safety and efficacy, the severity

−1
©
Drug Development & Research 4 (15) 2023: 001-005

of the disease or condition it treats, and the drug's benefits continued development of innovative and effective drugs
and risks compared to existing treatments [4]. is essential to improving global health and well-being [8].
Drug development is a challenging and expensive process, In addition to the challenges mentioned above, drug
with many potential pitfalls and roadblocks. One of the development also faces regulatory hurdles. The regulatory
most significant challenges is finding promising drug process is intended to ensure that new drugs are safe and
targets, as only a small percentage of drug candidates make effective, but it can also be time-consuming and expensive.
it to the market. Additionally, clinical trials can take years to The regulatory agency requires extensive data on the drug's
complete and cost billions of dollars, making it challenging safety and efficacy, which means that drug developers
for smaller companies to fund drug development. Another must invest in clinical trials that can take several years to
challenge is ensuring that drugs are safe and effective for all complete. Moreover, the regulatory agency may require
patients. Genetic differences between individuals can affect additional post-marketing surveillance studies to monitor
how they respond to drugs, which means that some drugs the drug's long-term safety and efficacy, which can further
may be effective for certain subpopulations but not others. delay the drug's availability on the market [9].
This variability can make it challenging to design clinical Another challenge in drug development is the high failure
trials and develop drugs that work for everyone [5]. rate. Despite extensive preclinical testing and clinical trials,
most drug candidates fail to make it to the market. This is
DISCUSSION because the human body is a complex system, and drug
Drug development is a complex and lengthy process that developers must take into account various factors that can
involves multiple stages and challenges. The goal of drug affect a drug's safety and efficacy. For example, a drug that
development is to create safe and effective treatments for shows promising results in preclinical studies may not have
various diseases and conditions that can improve patient the same effect in humans, or it may cause unexpected
outcomes and quality of life. The first stage of drug side effects. Despite these challenges, drug development
development is the discovery phase, where scientists identify is essential for improving patient outcomes and quality of
potential drug targets and develop new molecules that can life. The development of new drugs can provide hope for
interact with those targets. Once a promising compound patients with previously untreatable or poorly managed
is identified, it undergoes preclinical testing to determine conditions. Innovative drugs can also provide an alternative
its safety and efficacy in animal models. Preclinical testing to existing treatments that may have significant side effects
helps researchers understand the potential side effects and or limited efficacy.
toxicity of the drug [6]. Moreover, drug development has a significant impact on
The next stage is clinical trials, which are the most critical public health and the economy. New drugs can reduce
stage of drug development. Clinical trials involve testing healthcare costs by preventing or treating diseases more
the drug on human subjects in three phases, with the goal effectively, reducing hospitalization and long-term care
of determining the drug's safety, efficacy, and optimal costs. Drug development can also create jobs and stimulate
dosing. If a drug passes all three phases of clinical trials, economic growth in the pharmaceutical industry and
the developer submits a New Drug Application (NDA) to related sectors [10].
the regulatory agency for approval. The regulatory agency
reviews the NDA and decides whether to approve the
CONCLUSION
drug for marketing based on the drug's safety, efficacy, and Drug development is a lengthy and complex process that
benefits compared to existing treatments [7]. involves multiple stages and requires the collaboration
Drug development is not without its challenges. One of of scientists, researchers, and regulatory bodies. Despite
the most significant challenges is finding promising drug the challenges and risks, drug development is essential
targets, as only a small percentage of drug candidates make for improving patient outcomes and quality of life. By
it to the market. Additionally, clinical trials can take years to understanding the drug development process and the
complete and cost billions of dollars, making it challenging challenges involved, we can support and promote the
for smaller companies to fund drug development. Ensuring development of safe and effective drugs.
that drugs are safe and effective for all patients is another
challenge, as genetic differences between individuals can ACKNOWLEDGEMENT
affect how they respond to drugs. Despite these challenges, None
drug development is crucial for improving patient outcomes
and quality of life. By understanding the drug development CONFLICT OF INTEREST
process and the challenges involved, we can support and
None
promote the development of safe and effective drugs. The

2−
 Lucia T. – Drug development: stages, challenges, and importance...

REFERENCES

1. Yang Y, Adelstein SJ, Kassis AI, et al. Target discovery from data 6. Zhang X, Li L, Ng MK, et al. Drug–target interaction prediction by
mining approaches. Drug Disco Today. 2009;14:147-154. integrating multitier network data. Comput Chem. 2017;69:185-193.

2. Yildirim MA, Goh KI, Cusick ME, et al. Drug-target network. Nat 7. Wang YC, Yang ZX, Wang Y, et al. Computationally probing drug-
Biotechnol. 2007;25:1119-1126. protein interactions via support vector machine. Lett Drug Des
Discov. 2010;7:370-378.
3. Bultinck J, Lievens S, Tavernier J, et al. Protein-protein
interactions: network analysis and applications in drug discovery. 8. Ezzat A, Zhao P, Wu M, et al. Drug-target interaction prediction with
Curr Pharm Des. 2012;18:4619-4629. graph regularized matrix factorization. IEEE/ACM. 2016;14:646-656.

4. Yamanishi Y, Araki M, Gutteridge A, et al. Prediction of drug-target 9. Lu L, Yu H. DR2DI: a powerful computational tool for predicting novel
interaction networks from the integration of chemical and genomic drug-disease associations. J Comput Aided Mol Des. 2018;32:633-
spaces. Bioinformatics. 2008;24:13:232-240. 642.

5. Sams-Dodd F. Target-based drug discovery: is something wrong? 10. Wishart DS, Knox C, Guo AC, et al. Drug Bank: a knowledgebase
Drug Disco Today. 2005;10:139-147. for drugs, drug actions and drug targets. Nucleic Acids Res Spec
Publ. 2008;36:901-906.

−3