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Risk and opportunities in development of new drug
Corresponding Author(s) : Mamidi Ramya
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 4 (2023): 2023 Volume -11 - Issue 4
Abstract
Drug discovery is a process which aims at identifying a compound therapeutically useful in curing and treating disease. This process involves the identification of candidates, synthesis, characterization, validation, optimization, screening and assays for therapeutic efficacy. Once a compound has shown its significance in these investigations, it will initiate the process of drug development earlier to clinical trials. New drug development process must continue through several stages in order to make a medicine that is safe, effective, and has approved all regulatory requirements. Drug Regulatory Affairs refers to all aspects within the pharmaceutical process on drug discovery and research which also deals with many risks and opportunities of drug development and they have subject to different degrees of regulations of different countries such as India, USA, Europe. The pharmaceutical law frame is used as guidelines on covering 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. The role of Regulatory affairs professionals deals with all these aspects to get a desired result of drug development. The health authorities are framed to guide and analyse the drug which fulfils the appropriate quality and efficacy.
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- Strovel J, Sittampalam S, Coussens NP, Hughes M, Inglese J, Kurtz A, et al. (July 1, 2016). "Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies". Assay Guidance Manual. Eli Lilly & Company and the National Center for Advancing Translational Sciences. PMID 22553881.
- Jump up to:a b Taylor D (2015). "The Pharmaceutical Industry and the Future of Drug Development". Issues in Environmental Science and Technology. Royal Society of Chemistry: 1–33. doi:10.1039/9781782622345-00001. ISBN 978-1-78262-189-8.
- Everts, Maaike; Cihlar, Tomas; Bostwick, J. Robert; Whitley, Richard J. (6 January 2017). "Accelerating Drug Development: Antiviral Therapies for Emerging Viruses as a Model". Annual Review of Pharmacology and Toxicology. 57 (1): 155–169. doi:10.1146/annurev-pharmtox-010716-104533. ISSN 0362-1642. PMID 27483339. Retrieved 2 November 2021.
- Jump up to:a b c d "The Drug Development Process". U.S. Food and Drug Administration (FDA). 4 January 2018. Retrieved 21 March 2020.
- Madorran E, Stožer A, Bevc S, Maver U (2020). "In vitro toxicity model: Upgrades to bridge the gap between preclinical and clinical research". Bosnian Journal of Basic Medical Sciences. 20 (2): 157–68. doi:10.17305/bjbms.2019.4378. PMC 7202182. PMID 31621554.
- Ciociola AA, Cohen LB, Kulkarni P (May 2014). "How drugs are developed and approved by the FDA: current process and future directions". The American Journal of Gastroenterology. 109 (5): 620–3. doi:10.1038/ajg.2013.407. PMID 24796999. S2CID 205100166.
- Jump up to:a b c d Strovel J, Sittampalam S, Coussens NP, Hughes M, Inglese J, Kurtz A, et al. (July 1, 2016). "Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies". Assay Guidance Manual. Eli Lilly & Company and the National Center for Advancing Translational Sciences. PMID 22553881.
- ^ "Vaccine Product Approval Process". U.S. Food and Drug Administration (FDA). 30 January 2018. Retrieved 21 March 2020.
- Van Norman GA (June 2019). "Phase II Trials in Drug Development and Adaptive Trial Design". JACC. Basic to Translational Science. 4 (3): 428–437. doi:10.1016/j.jacbts.2019.02.005. PMC 6609997. PMID 31312766.
- Fogel DB (September 2018). "Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review". Contemporary Clinical Trials Communications. 11: 156–164. doi:10.1016/j.conctc.2018.08.001. PMC 6092479. PMID 30112460.
- "R&D costs are on the rise". Medical Marketing and Media. 38 (6): 14. June 1, 2003. Archived from the original on October 18, 2016.
- Jump up to:a b "Clinical development success rates: 2006–2015" (PDF). BIO Industry Analysis. June 2016.
- Wang Y (2012). "Extracting knowledge from failed development programmes". Pharmaceutical Medicine. 26 (2): 91–96. doi:10.1007/BF03256897. S2CID 17171991
- Harris B. (2013). 3 Ways Big Pharma Uses Big Data. Available at: http://www.healthcareitnews.com/ news/3-ways-big-pharma-uses-big-data.
- Aimo khan, Thomas Wieland. (2016). Managing risk in drug discovery: reproducibility of published findings. Available at: https://www.ncb.nlm.nih.gov/ pmc/articles/PMC4785199
- Bruce Baron, Bill Deakin, Martien Kas. (2014). Opportunities to improve and accelerate the drug development pipeline.
- Oktay Yildirim, Matthias Gottwald. (2016). Opportunities and challenges for drug development. Available at: https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC5138214
- J.Van Boxtel, B.Bantoso, I.R.Edwards. (2008). Drugs benefits and risks. International textbook of clinical pharmacology. Available at: https:// www.who.int/medicines/techinical_briefing/tbs/drugs_regulation_history_present_future.pdf
- Improving and accelerating therapeutic development for nervous system disorders. (2014). Available at: https://www.ncbi.nlm.nih.gov/books/NBK195047
- Forced Degradation Study: An Important Tool in Drug Development Authors: A.B. Roge, P.S. Tarte, M.M. Kumare, G.R. Shendarkar, S.M. Vadvalkar Journal: Asian Journal of Pharmaceutical Research http://anvpublication.org/Universal_Search.aspx?What=CitationList+&tmp_PID=+191025200559506183
References
Strovel J, Sittampalam S, Coussens NP, Hughes M, Inglese J, Kurtz A, et al. (July 1, 2016). "Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies". Assay Guidance Manual. Eli Lilly & Company and the National Center for Advancing Translational Sciences. PMID 22553881.
Jump up to:a b Taylor D (2015). "The Pharmaceutical Industry and the Future of Drug Development". Issues in Environmental Science and Technology. Royal Society of Chemistry: 1–33. doi:10.1039/9781782622345-00001. ISBN 978-1-78262-189-8.
Everts, Maaike; Cihlar, Tomas; Bostwick, J. Robert; Whitley, Richard J. (6 January 2017). "Accelerating Drug Development: Antiviral Therapies for Emerging Viruses as a Model". Annual Review of Pharmacology and Toxicology. 57 (1): 155–169. doi:10.1146/annurev-pharmtox-010716-104533. ISSN 0362-1642. PMID 27483339. Retrieved 2 November 2021.
Jump up to:a b c d "The Drug Development Process". U.S. Food and Drug Administration (FDA). 4 January 2018. Retrieved 21 March 2020.
Madorran E, Stožer A, Bevc S, Maver U (2020). "In vitro toxicity model: Upgrades to bridge the gap between preclinical and clinical research". Bosnian Journal of Basic Medical Sciences. 20 (2): 157–68. doi:10.17305/bjbms.2019.4378. PMC 7202182. PMID 31621554.
Ciociola AA, Cohen LB, Kulkarni P (May 2014). "How drugs are developed and approved by the FDA: current process and future directions". The American Journal of Gastroenterology. 109 (5): 620–3. doi:10.1038/ajg.2013.407. PMID 24796999. S2CID 205100166.
Jump up to:a b c d Strovel J, Sittampalam S, Coussens NP, Hughes M, Inglese J, Kurtz A, et al. (July 1, 2016). "Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies". Assay Guidance Manual. Eli Lilly & Company and the National Center for Advancing Translational Sciences. PMID 22553881.
^ "Vaccine Product Approval Process". U.S. Food and Drug Administration (FDA). 30 January 2018. Retrieved 21 March 2020.
Van Norman GA (June 2019). "Phase II Trials in Drug Development and Adaptive Trial Design". JACC. Basic to Translational Science. 4 (3): 428–437. doi:10.1016/j.jacbts.2019.02.005. PMC 6609997. PMID 31312766.
Fogel DB (September 2018). "Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review". Contemporary Clinical Trials Communications. 11: 156–164. doi:10.1016/j.conctc.2018.08.001. PMC 6092479. PMID 30112460.
"R&D costs are on the rise". Medical Marketing and Media. 38 (6): 14. June 1, 2003. Archived from the original on October 18, 2016.
Jump up to:a b "Clinical development success rates: 2006–2015" (PDF). BIO Industry Analysis. June 2016.
Wang Y (2012). "Extracting knowledge from failed development programmes". Pharmaceutical Medicine. 26 (2): 91–96. doi:10.1007/BF03256897. S2CID 17171991
Harris B. (2013). 3 Ways Big Pharma Uses Big Data. Available at: http://www.healthcareitnews.com/ news/3-ways-big-pharma-uses-big-data.
Aimo khan, Thomas Wieland. (2016). Managing risk in drug discovery: reproducibility of published findings. Available at: https://www.ncb.nlm.nih.gov/ pmc/articles/PMC4785199
Bruce Baron, Bill Deakin, Martien Kas. (2014). Opportunities to improve and accelerate the drug development pipeline.
Oktay Yildirim, Matthias Gottwald. (2016). Opportunities and challenges for drug development. Available at: https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC5138214
J.Van Boxtel, B.Bantoso, I.R.Edwards. (2008). Drugs benefits and risks. International textbook of clinical pharmacology. Available at: https:// www.who.int/medicines/techinical_briefing/tbs/drugs_regulation_history_present_future.pdf
Improving and accelerating therapeutic development for nervous system disorders. (2014). Available at: https://www.ncbi.nlm.nih.gov/books/NBK195047
Forced Degradation Study: An Important Tool in Drug Development Authors: A.B. Roge, P.S. Tarte, M.M. Kumare, G.R. Shendarkar, S.M. Vadvalkar Journal: Asian Journal of Pharmaceutical Research http://anvpublication.org/Universal_Search.aspx?What=CitationList+&tmp_PID=+191025200559506183