Risk & Opportunities in Development of new Drugs: A New Perspective

Year : 2023 | Volume : 01 | Issue : 02 | Page : 19-28

    Shubham Kumar

  1. Sweta Ravindra Singh


The procedures of drug discovery and development are briefly described in this article. Our goal is to assist researchers whose work may be pertinent to the discovery and/or development of new drugs in framing their research reports in a way that appropriately situates their findings within the drug discovery and development process and supports the efficient translation of preclinical research to humans. One overarching theme of our article is the length, complexity, and expense of the process, which forces the consideration of numerous biological targets for every new drug that is eventually approved for clinical use as well as the potential need for new research tools to examine each new target. The efficacy of the development process can be increased by studies that help to resolve any of the numerous scientific and practical problems that are involved in it. By being aware of these problems, actions can be taken early to improve chances of success.
Drug Regulatory Affairs refers to all facets of the pharmaceutical process of drug discovery and research, which also addresses numerous risks and opportunities of drug development, and which are subject to varying degrees of regulations of various nations, including India, the United States, and Europe. The pharmaceutical law framework is employed as guidelines on Quality, Safety, and Efficacy of a Drug as well as Health Authorities’ Attitudes and Requirements are Employed for the Correct Pathway of Pharmaceutical Needs and Have A Great Influence On The Drug Development Process And Had Success Through It. Professionals in regulatory affairs interact with each of these elements in order to achieve the intended outcome of drug development. The health authorities are designed to direct and analyses the medication that satisfies the required standards for quality and efficacy.

Keywords: pharmacology, drug discovery , opportunities, patient health , natural resources

[This article belongs to Recent Trends in Infectious Diseases(rtid)]

How to cite this article: Shubham Kumar, Sweta Ravindra Singh Risk & Opportunities in Development of new Drugs: A New Perspective rtid 2023; 01:19-28
How to cite this URL: Shubham Kumar, Sweta Ravindra Singh Risk & Opportunities in Development of new Drugs: A New Perspective rtid 2023 {cited 2023 Dec 30};01:19-28. Available from: https://journals.stmjournals.com/rtid/article=2023/view=130128


Munro D. SAS and GSK Pull Big Pharma into Big Data 2013
Rajashekar S, Abimanyu S. Risk and Opportunities in Development of New Drug. Research Journal of Pharmacy and Technology. 2020;13(6):3041-4.
Senthil T, Selvaraj V, Jawahar N, Venkatachalam S. An Overview of Indian Veterinary Medicine Regulation. International Journal of Pharmaceutical Research (09752366). 2020 Jul 2.
Wang Z, Yang B. General Process for Rational Design and Discovery of MTDs. InPolypharmacology: Principles and Methodologies 2022 Aug 2 (pp. 661-676). Cham: Springer International Publishing.
DiMasi JA, Feldman L, Seckler A, Wilson A. Trends in risks associated with new drug development: success rates for investigational drugs. Clinical Pharmacology & Therapeutics. 2010 Mar;87(3):272-7.
Katiyar C, Gupta A, Kanjilal S, Katiyar S. Drug discovery from plant sources: An integrated approach. Ayu. 2012 Jan;33(1):10.
Drews J. Drug discovery: a historical perspective. science. 2000 Mar 17;287(5460):1960-4.
Mohs RC, Greig NH. Drug discovery and development: Role of basic biological research. Alzheimer’s & Dementia: Translational Research & Clinical Interventions. 2017 Nov 1;3(4):651-7.
An overview of new drug discovery and development. (n.d.). PharmaTutor. Retrieved January 2, 2022, from https://www.pharmatutor.org/articles/an-overview-of-new-drug-discovery-and-development
Berdigaliyev N, Aljofan M. An overview of drug discovery and development. Future medicinal chemistry. 2020 Feb;12(10):939-47.
Steinmetz KL, Spack EG. The basics of preclinical drug development for neurodegenerative disease indications. BMC neurology. 2009 Jun;9(1):1-3.
Levine G, Abel N. Investigational new drugs: application, process, and trial. Journal of nuclear medicine technology. 1990 Dec 1;18(4):236-42.
Chiodin D, Cox EM, Edmund AV, Kratz E, Lockwood SH. Regulatory affairs 101: introduction to investigational new drug applications and clinical trial applications. Clinical and translational science. 2019 Jul;12(4):334-42.
Van Norman GA. Drugs, devices, and the FDA: part 1: an overview of approval processes for drugs. JACC: Basic to Translational Science. 2016 Apr;1(3):170-9.
Morgan S, Grootendorst P, Lexchin J, Cunningham C, Greyson D. The cost of drug development: a systematic review. Health policy. 2011 Apr 1;100(1):4-17.
Fargen KM, Frei D, Fiorella D, McDougall CG, Myers PM, Hirsch JA, Mocco J. The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?. Journal of neurointerventional surgery. 2013 Jul 1;5(4):269-75.
Kepplinger EE. FDA’s expedited approval mechanisms for new drug products. Biotechnology law report. 2015 Feb 1;34(1):15-37.
View of the stages of drug discovery and development process. (n.d.). Ajprd.Com. Retrieved January 2, 2022, from https://www.ajprd.com/index.php/journal/article/view/616/510
Sharrar RG, Dieck GS. Monitoring product safety in the postmarketing environment. Therapeutic advances in drug safety. 2013 Oct;4(5):211-9.
Raj N, Fernandes S, Charyulu NR, Dubey A, GS R, Hebbar S. Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada. Therapeutic advances in drug safety. 2019 Jul;10:2042098619865413.
Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. Jama. 1999 Mar 3;281(9):824-9.
Kleczyk E. Risk management in the development of new products in the pharmaceutical industry.
Azarnoff DL, Herting RL. Drug development: risks and problems. Annals of the New York Academy of Sciences. 1984 Dec;432(1):279-86.
Kannt A, Wieland T. Managing risks in drug discovery: reproducibility of published findings. Naunyn-Schmiedeberg’s Archives of Pharmacology. 2016 Apr;389:353-60.
Risk management – FDA’s Quality Risk Management approach to new drug applications. (2019, April 1). Drug Development and Delivery. https://drug-dev.com/fdas-quality-risk-management-approach-to-new-drug-applications/
Yildirim O, Gottwald M, Schüler P, Michel MC. Opportunities and challenges for drug development: public–private partnerships, adaptive designs and big data. Frontiers in pharmacology. 2016 Dec 6;7:461.
Surur AS, Fekadu A, Makonnen E, Hailu A. Challenges and opportunities for drug discovery in developing countries: the example of cutaneous leishmaniasis. ACS Medicinal Chemistry Letters. 2020 Sep 2;11(11):2058-62.
Norris SM, Palmer C, Stroud C, Altevogt BM. Forum on Neuroscience and Nervous System Disorders, Board on Health Science Policy, Institute of Medicine. In Developing a 21st Century Neuroscience: Workshop Summary 2015.

Regular Issue Subscription Review Article
Volume 01
Issue 02
Received December 1, 2023
Accepted December 18, 2023
Published December 30, 2023