Clinical Drug Discovery Process

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A Clinical Drug Discovery Process is a pharmacological process to discover new candidate pharmaceutical drugs.




  • (Wikipedia, 2023) ⇒ Retrieved:2023-2-24.
    • In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered.[1]

      Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery, as with penicillin. More recently, chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that had a desirable therapeutic effect in a process known as classical pharmacology. After sequencing of the human genome allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease-modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells and then in animals for efficacy.[2]

      Modern drug discovery involves the identification of screening hits,[3] medicinal chemistry [4] and optimization of those hits to increase the affinity, selectivity (to reduce the potential of side effects), efficacy/potency, metabolic stability (to increase the half-life), and oral bioavailability. Once a compound that fulfills all of these requirements has been identified, the process of drug development can continue. If successful, clinical trials are developed.[5]

      Modern drug discovery is thus usually a capital-intensive process that involves large investments by pharmaceutical industry corporations as well as national governments (who provide grants and loan guarantees). Despite advances in technology and understanding of biological systems, drug discovery is still a lengthy, "expensive, difficult, and inefficient process" with low rate of new therapeutic discovery.[6] In 2010, the research and development cost of each new molecular entity was about US$1.8 billion.[7] In the 21st century, basic discovery research is funded primarily by governments and by philanthropic organizations, while late-stage development is funded primarily by pharmaceutical companies or venture capitalists.[8] To be allowed to come to market, drugs must undergo several successful phases of clinical trials, and pass through a new drug approval process, called the New Drug Application in the United States.

      Discovering drugs that may be a commercial success, or a public health success, involves a complex interaction between investors, industry, academia, patent laws, regulatory exclusivity, marketing and the need to balance secrecy with communication.[9] Meanwhile, for disorders whose rarity means that no large commercial success or public health effect can be expected, the orphan drug funding process ensures that people who experience those disorders can have some hope of pharmacotherapeutic advances.

  1. "The drug development process". US Food and Drug Administration. 4 January 2018. Retrieved 18 December 2019.
  2. "The drug development process: Step 1: Discovery and development". US Food and Drug Administration. 4 January 2018. Retrieved 18 December 2019.
  3. Helleboid S, Haug C, Lamottke K, et al. The Identification of Naturally Occurring Neoruscogenin as a Bioavailable, Potent, and High-Affinity Agonist of the Nuclear Receptor RORα (NR1F1). Journal of Biomolecular Screening. 2014;19(3):399–406.
  4. Herrmann, A., Roesner, M., Werner, T. et al. Potent inhibition of HIV replication in primary human cells by novel synthetic polyketides inspired by Aureothin. Sci Rep 10, 1326 (2020).
  5. "The drug development process: Step 3: Clinical research". US Food and Drug Administration. 4 January 2018. Retrieved 18 December 2019.
  6. Anson D, Ma J, He JQ (1 May 2009). "Identifying Cardiotoxic Compounds". Genetic Engineering & Biotechnology News. TechNote. Vol. 29, no. 9. Mary Ann Liebert. pp. 34–35. ISSN 1935-472X. OCLC 77706455. Archived from the original on 21 September 2012. Retrieved 25 July 2009.
  7. Paul SM, Mytelka DS, Dunwiddie CT, Persinger CC, Munos BH, Lindborg SR, Schacht AL (March 2010). "How to improve R&D productivity: the pharmaceutical industry's grand challenge". Nature Reviews. Drug Discovery. 9 (3): 203–14. doi:10.1038/nrd3078. PMID 20168317. S2CID 1299234.
  8. Current Model for Financing Drug Development: From Concept Through Approval. Institute of Medicine (US), Forum on Drug Discovery, Development, and Translation, National Academies Press, Washington (DC). 2009.
  9. Warren J (April 2011). "Drug discovery: lessons from evolution". British Journal of Clinical Pharmacology. 71 (4): 497–503. doi:10.1111/j.1365-2125.2010.03854.x. PMC 3080636. PMID 21395642.