PRECLINICAL TOXICITY TESTING AND ADVERSE DRUG REACTION MONITORING IN DRUG DISCOVERY PROCESS
Authors/Creators
- 1. Roland Institute of Pharmaceutical Sciences, Berhampur-760010, Odisha, India.
- 2. Department of Pharmacology, GITAM School of Pharmacy, GITAM Deemed to be University, Visakhapatnam-530045, Andhra Pradesh, India.
Abstract
The process of drug discovery and development involves a synchronous activities of both preclinical toxicity testing methods and adverse drug reaction monitoring at clinical set ups. In clinical phases of drug development, pharmacovigilance guarantee the safety of pharmaceutical usage by identifying and evaluating adverse drug reactions (ADRs). An appropriate and well-structured ADR monitoring could help patient safety by determining the degree and causation of ADRs by certain drugs. Recently, the ADR detection and assessment are being improved by new instruments, algorithms, scientific and regulatory developments. Early detection and proactive management of ADRs can help to mitigate potential risks to patient safety and ensure the success of drug development endeavours.
Files
31 WJPSR 772.pdf
Files
(695.7 kB)
| Name | Size | Download all |
|---|---|---|
|
md5:52eff59c3554565e8326ebb1fad23793
|
695.7 kB | Preview Download |
Additional details
References
- 1. DiMasi, J., Tufts Center for the Study of Drug Development pegs costs of a new prescription medicine at $802 million. press release, Tufts Center for the Study of Drug Development, 2001; 30: 461-491.
- 2. Berlin, J.A., S.C. Glasser, and S.S. Ellenberg, Adverse event detection in drug development: recommendations and obligations beyond phase 3. Am J Public Health, 2008; 98(8): 1366-71.
- 3. Tan, Y., Y. Hu, X. Liu, Z. Yin, X.-w. Chen, and M. Liu, Improving drug safety: From adverse drug reaction knowledge discovery to clinical implementation. Methods, 2016; 110: 14-25.
- 4. Lalonde, R., K. Kowalski, M. Hutmacher, W. Ewy, D. Nichols, P. Milligan, et al., Model‐based drug development. Clinical Pharmacology & Therapeutics, 2007; 82(1): 21-32.
- 5. Mohs, R.C. and N.H. Greig, Drug discovery and development: Role of basic biological research. Alzheimer's & Dementia: Translational Research & Clinical Interventions, 2017; 3(4): 651-657.
- 6. Dutta, A.S., Discovery of new medicines. The textbook of pharmaceutical medicine, 2009; 1-80.
- 7. Katsila, T., G.A. Spyroulias, G.P. Patrinos, and M.-T. Matsoukas, Computational approaches in target identification and drug discovery. Computational and structural biotechnology journal, 2016; 14: 177-184.
- 8. Sakharkar, M.K., K. Rajamanickam, C.S. Babu, J. Madan, R. Chandra, and J. Yang, Preclinical: Drug Target Identification and Validation in Human, in Encyclopedia of Bioinformatics and Computational Biology, S. Ranganathan, et al., Editors. 2019, Academic Press: Oxford. p. 1093-1098.
- 9. Kavlock, R. and G.T. Ankley, A framework for a computational toxicology research program. 2003: Office of Research and Development, US Environmental Protection Agency.
- 10. Hartung, T. and S. Hoffmann, Food for thought... on in silico methods in toxicology. ALTEX-Alternatives to animal experimentation, 2009; 26(3): 155-166.
- 11. Yoo, S., K. Noh, M. Shin, J. Park, K.-H. Lee, H. Nam, et al., In silico profiling of systemic effects of drugs to predict unexpected interactions. Scientific Reports, 2018; 8(1): 1612.
- 12. Johnson, C., E. Ahlberg, L.T. Anger, L. Beilke, R. Benigni, J. Bercu, et al., Skin sensitization in silico protocol. Regul Toxicol Pharmacol, 2020; 116: 104688.
- 13. Bassan, A., V.M. Alves, A. Amberg, L.T. Anger, L. Beilke, A. Bender, et al., In silico approaches in organ toxicity hazard assessment: Current status and future needs for predicting heart, kidney and lung toxicities. Comput Toxicol, 2021; 20.
- 14. Myatt, G.J., E. Ahlberg, Y. Akahori, D. Allen, A. Amberg, L.T. Anger, et al., In silico toxicology protocols. Regul Toxicol Pharmacol, 2018; 96: 1-17.
- 15. Jorgensen, W.L., Efficient drug lead discovery and optimization. Acc Chem Res, 2009; 42(6): 724-33.
- 16. Barreiro, G., J.T. Kim, C.R. Guimarães, C.M. Bailey, R.A. Domaoal, L. Wang, et al., From docking false-positive to active anti-HIV agent. Journal of medicinal chemistry, 2007; 50(22): 5324-5329.
- 17. Friesner, R.A., J.L. Banks, R.B. Murphy, T.A. Halgren, J.J. Klicic, D.T. Mainz, et al., Glide: a new approach for rapid, accurate docking and scoring. 1. Method and assessment of docking accuracy. Journal of medicinal chemistry, 2004; 47(7): 1739-1749.
- 18. Congreve, M., G. Chessari, D. Tisi, and A.J. Woodhead, Recent developments in fragment-based drug discovery. Journal of medicinal chemistry, 2008; 51(13): 3661-3680.
- 19. Gohlke, H. and G. Klebe, Approaches to the description and prediction of the binding affinity of small‐molecule ligands to macromolecular receptors. Angewandte Chemie International Edition, 2002; 41(15): 2644-2676.
- 20. Verma, S. and R.K. Pathak, Chapter 16 - Discovery and optimization of lead molecules in drug designing, in Bioinformatics, D.B. Singh and R.K. Pathak, Editors. 2022, Academic Press. p. 253-267.
- 21. Warner, D.S., M.L. James, D.T. Laskowitz, and E.F. Wijdicks, Translational research in acute central nervous system injury: lessons learned and the future. JAMA neurology, 2014; 71(10): 1311-1318.
- 22. Henderson, V.C., J. Kimmelman, D. Fergusson, J.M. Grimshaw, and D.G. Hackam, Threats to validity in the design and conduct of preclinical efficacy studies: a systematic review of guidelines for in vivo animal experiments. PLoS medicine, 2013; 10(7): e1001489.
- 23. Landis, S.C., S.G. Amara, K. Asadullah, C.P. Austin, R. Blumenstein, E.W. Bradley, et al., A call for transparent reporting to optimize the predictive value of preclinical research. Nature, 2012; 490(7419): 187-191.
- 24. Kilkenny, C., N. Parsons, E. Kadyszewski, M.F. Festing, I.C. Cuthill, D. Fry, et al., Survey of the quality of experimental design, statistical analysis and reporting of research using animals. PloS one, 2009; 4(11): e7824.
- 25. McGonigle, P. and M. Williams, Preclinical Pharmacology and Toxicology - Contributions to the Translational Interface☆, in Reference Module in Biomedical Sciences. 2017, Elsevier.
- 26. Lakshmanan, M., Preclinical Toxicity Studies, in Introduction to Basics of Pharmacology and Toxicology: Volume 3: Experimental Pharmacology: Research Methodology and Biostatistics, M. Lakshmanan, D.G. Shewade, and G.M. Raj, Editors. 2022, Springer Nature Singapore: Singapore. p. 625-648.
- 27. Mayorga, C., G. Celik, P. Rouzaire, P. Whitaker, P. Bonadonna, J. Rodrigues‐ Cernadas, et al., In vitro tests for drug hypersensitivity reactions: an ENDA/EAACI Drug Allergy Interest Group position paper. Allergy, 2016; 71(8): 1103-1134.
- 28. Torres, M.J., M. Blanca, J. Fernandez, A. Romano, A. De Weck, W. Aberer, et al., Diagnosis of immediate allergic reactions to beta‐lactam antibiotics. Allergy, 2003; 58(10): 961-972.
- 29. Romano, A., M. Blanca, M. Torres, A. Bircher, W. Aberer, K. Brockow, et al., Diagnosis of nonimmediate reactions to β‐lactam antibiotics. Allergy, 2004; 59(11): 1153-1160.
- 30. Sachs, B., T. Al Masaoudi, H. Merk, and S. Erdmann, Combined in vivo and in vitro approach for the characterization of penicillin‐specific polyclonal lymphocyte reactivity: tolerance tests with safe penicillins instead of challenge with culprit drugs. British Journal of Dermatology, 2004; 151(4): 809-816.
- 31. Mayorga, C., D.G. Ebo, D.M. Lang, W.J. Pichler, V. Sabato, M.A. Park, et al., Controversies in drug allergy: In vitro testing. Journal of Allergy and Clinical Immunology, 2019; 143(1): 56-65.
- 32. Kubota, Y., S. Imayama, A. Toshitani, H. Miyahara, T. Tanahashi, Y. Uemura, et al., Sulfidoleukotriene release test (CAST) in hypersensitivity to nonsteroidal anti- inflammatory drugs. International archives of allergy and immunology, 1997; 114(4): 361-366.
- 33. Pâris-Köhler, A., P. Demoly, L. Persi, B. Lebel, J. Bousquet, and B. Arnoux, In vitro diagnosis of cypress pollen allergy by using cytofluorimetric analysis of basophils (Basotest). Journal of allergy and clinical immunology, 2000; 105(2): 339-345.
- 34. Quinn, B., Chapter 3 - Preparation and Maintenance of Live Tissues and Primary Cultures for Toxicity Studies, in Biochemical Ecotoxicology, F. Gagné, Editor. 2014, Academic Press: Oxford. p. 33-47.
- 35. In Vitro Toxicity Testing. 2024; Available from: https://www.criver.com/products-services/safety-assessment/toxicology-services/vitro-toxicology?region=3701.
- 36. Heddle, J.A., A rapid in vivo test for chromosomal damage. Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, 1973; 18(2): 187-190.
- 37. Garle, M.J., J.H. Fentem, and J.R. Fry, In vitro cytotoxicity tests for the prediction of acute toxicity in vivo. Toxicology in Vitro, 1994; 8(6): 1303-1312.
- 38. Pawar, B., T. Gupta, N. Vasdev, M. Tekade, B. Arafat, and R.K. Tekade, Chapter 1 - Understanding pharmacotoxicology, in Essentials of Pharmatoxicology in Drug Research, R. Tekade, Editor. 2023, Academic Press. p. 1-28.
- 39. Dobrovolskaia, M.A. and S.E. McNeil, Understanding the correlation between in vitro and in vivo immunotoxicity tests for nanomedicines. Journal of Controlled Release, 2013; 172(2): 456-466.
- 40. DelBaugh, R.M., D.A. Kerr, L. Dominguez-Konicki, J.A. Beard, S.R. Gordon, J.M. Adler, et al., Metastatic Neuroendocrine Neoplasms to the Pancreas: Two Unusual Cases and a Review of the Literature. International Journal of Surgical Pathology, 2024; 32(3): 523-532.
- 41. Kokova, V., METHODS FOR DETERMINING SUB-ACUTE, SUB-CHRONIC, AND CHRONIC TOXICITY OF CHEMICAL COMPOUNDS. KNOWLEDGE-International Journal, 2023; 59(4): 257-261.
- 42. What Toxicity Data Is Needed Before First-In-Human (FIH) Trials? 2023; Available from: https://labtesting.wuxiapptec.com/2024/02/05/toxicity-data- before-first-in-human-trials/.
- 43. Jacobson-Kram, D. and G. Mills, Leveraging exploratory investigational new drug studies to accelerate drug development. Clinical cancer research, 2008; 14(12): 3670-3674.
- 44. Garner, R.C. and G. Lappin, The phase 0 microdosing concept. British journal of clinical pharmacology, 2006; 61(4): 367.
- 45. Cohen, A., Should we tolerate tolerability as an objective in early drug development? British journal of clinical pharmacology, 2007; 64(3): 249.
- 46. Suntharalingam, G., M.R. Perry, S. Ward, S.J. Brett, A. Castello-Cortes, M.D. Brunner, et al., Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. New England Journal of Medicine, 2006; 355(10): 1018- 1028.
- 47. Milton, M.N. and C.J. Horvath, The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development. Toxicologic pathology, 2009; 37(3): 363-371.
- 48. Group, E.S., Expert scientific group on phase one clinical trials-final report. http://www.tsoshop.co.uk, 2006.
- 49. CONSULTATION, E., COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP), 2007.
- 50. Kenter, M.J. and A.F. Cohen, Establishing risk of human experimentation with drugs: lessons from TGN1412. The Lancet, 2006; 368(9544): 1387-1391.
- 51. Hutchinson, T.H., C. Bögi, M.J. Winter, and J.W. Owens, Benefits of the maximum tolerated dose (MTD) and maximum tolerated concentration (MTC) concept in aquatic toxicology. Aquatic Toxicology, 2009; 91(3): 197-202.
- 52. Sewell, F., M. Corvaro, A. Andrus, J. Burke, G. Daston, B. Delaney, et al., Recommendations on dose level selection for repeat dose toxicity studies. Archives of Toxicology, 2022; 96(7): 1921-1934.
- 53. Aardema, M.J. and J.T. MacGregor, Toxicology and genetic toxicology in the new era of "toxicogenomics": impact of "-omics" technologies. Toxicogenomics, 2003; 171-193.
- 54. Pugsley, M.K., S. Authier, and M. Curtis, Principles of safety pharmacology. British journal of pharmacology, 2008; 154(7): 1382-1399.
- 55. Bass, J.L., M. Corwin, D. Gozal, C. Moore, H. Nishida, S. Parker, et al., The effect of chronic or intermittent hypoxia on cognition in childhood: a review of the evidence. Pediatrics, 2004; 114(3): 805-816.
- 56. Kawabata, T.T. and E.W. Evans, Development of immunotoxicity testing strategies for immunomodulatory drugs. Toxicol Pathol, 2012; 40(2): 288-93.
- 57. International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; guidance for industry; availability. Notice. Fed Regist, 2015; 80(17): 4282-3.
- 58. Balster, R. and S. Walsh, Abuse liability evaluation. Encyclopedia of psychopharmacology, 2010; 2-7.
- 59. The Vital Role Of Toxicity Studies In Evaluating New Drugs. 2023; Available from: https://labtesting.wuxiapptec.com/2021/12/07/the-vital-role-of-toxicity-studies-in- evaluating-new-drugs/
- 60. Manohar D. Kengar, K.K.P., Akshay K. Ade, Sumesh M. Kumbhar, Chetan D. Patil, Ashutosh R. Ganjave, Introduction to Pharmacovigilance and Monitoring. Asian Journal of Pharmaceutical Research, 2019.
- 61. Paoletti, X., C. Le Tourneau, J. Verweij, L.L. Siu, L. Seymour, S. Postel-Vinay, et al., Defining dose-limiting toxicity for phase 1 trials of molecularly targeted agents: Results of a DLT-TARGETT international survey. European Journal of Cancer, 2014; 50(12): 2050-2056.
- 62. Molife, L.R., S. Alam, D. Olmos, M. Puglisi, K. Shah, R. Fehrmann, et al., Defining the risk of toxicity in phase I oncology trials of novel molecularly targeted agents: a single centre experience. Annals of Oncology, 2012; 23(8): 1968-1973.
- 63. Stricker, B.H. and B.M. Psaty, Detection, verification, and quantification of adverse drug reactions. Bmj, 2004; 329(7456): 44-7.
- 64. Levien, M.G., J. Gravette, and J.M. Hilden, CHAPTER 10 - Principles of chemotherapy, in Clinical Ophthalmic Oncology, A.D. Singh, et al., Editors. 2007, W.B. Saunders: Edinburgh. p. 50-53.
- 65. Nikfar, S. and S. Mozaffari, Safety testing, clinical studies, in Encyclopedia of Toxicology (Fourth Edition), P. Wexler, Editor. 2024, Academic Press: Oxford. p. 403-405.
- 66. Suvarna, V., Phase IV of drug development. Perspectives in clinical research, 2010; 1(2): 57-60.
- 67. Alomar, M.J., Factors affecting the development of adverse drug reactions. Saudi pharmaceutical journal, 2014; 22(2): 83-94.
- 68. Singh, B.N. and K.H. Kim, Floating drug delivery systems: an approach to oral controlled drug delivery via gastric retention. Journal of Controlled release, 2000; 63(3): 235-259.
- 69. Linden, M., Differences in adverse drug reactions in phase III and phase IV of the drug evaluation process. Psychopharmacol Bull, 1993; 29(1): 51-6.
- 70. Lobo, M.G.A.d.A., S.M.B. Pinheiro, J.G.D. Castro, V.G. Momenté, and M.-C.S. Pranchevicius, Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacology and Toxicology, 2013; 14(1): 5.
- 71. Sahu, R.K., R. Yadav, P. Prasad, A. Roy, and S. Chandrakar, Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance. Springerplus, 2014; 3: 695.
- 72. Pomeranz, J. and B. Bruce, Incidences of adverse drug reactions: a meta-analysis. Jama, 1998; 279(15): 1200.
- 73. Adverse Drug Events, Adverse Drug Reactions and Medication Errors Frequently Asked Questions. VA Center for Medication Safety and VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel, 2006.
- 74. Lazarou, J., B.H. Pomeranz, and P.N. Corey, Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. Jama, 1998; 279(15): 1200-1205.
- 75. Pal, S.N., C. Duncombe, D. Falzon, and S. Olsson, WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug safety, 2013; 36: 75-81.
- 76. Brewer, T. and G.A. Colditz, Postmarketing Surveillance and Adverse Drug ReactionsCurrent Perspectives and Future Needs. JAMA, 1999; 281(9): 824-829.