Abstract
There are persistent efforts to discover newer drugs to address huge unmet needs in the treatment of various disease conditions. The process of drug discovery and development involves both the preclinical and clinical studies which are very challenging and have huge commercial interests. Following the scientific malpractice in the pharmaceutical industries and contract research laboratories in the USA, the “good laboratory practice (GLP)” regulations were enforced in the arena of preclinical drug testing in the late 1970s. In 1981, the Organization for Economic Cooperation and Development (OECD) also developed its GLP principles which are internationally accepted. Given the public health and environmental safety concerns, various regulations and guidelines emphasize the compliance for GLP in the preclinical or nonclinical health and environmental safety studies. GLP assures the regulatory authority that the nonclinical safety data they receive from the sponsors are of high quality and accuracy that can be relied on in the risk assessment process for the product registration. The accreditation and compliance for GLP are voluntary for the test facilities and are required in the case of the regulatory submission. The present chapter covers the overview of the principles of GLP with the primary focus on requirements related to the test system in preclinical animal studies during the new drug development.
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References
Sinha S, Vohora D (2018) Drug discovery and development: an overview. In: Pharmaceutical medicine and translational clinical Research. Academic Press, Boston, pp 19–32
Gad SC (ed) (2001) Regulatory toxicology. CRC Press, Boca Raton, FL
Kille JW (2017) Regulatory toxicology. In: A comprehensive guide to toxicology in nonclinical drug development. Academic Press, Cambridge, pp 499–539
Gad SC (ed) (2006) Animal models in toxicology. CRC Press, Boca Raton
Saganuwan SA (2017) Toxicity studies of drugs and chemicals in animals: an overview. Bulg J Vet Med 20(4):291–318
Colerangle JB (2017) Preclinical development of non oncogenic drugs (small and large molecules). In: A comprehensive guide to toxicology in nonclinical drug development. Academic Press, Cambridge, pp 659–683
Dorato MA, Buckley LA (2007) Toxicology testing in drug discovery and development. Curr Protoc Toxicol 31(1):19–11
OECD (1998) OECD Principles of good laboratory practice (as revised in 1997)
Bode G (2018) Regulatory guidance: ICH, EMA, FDA. In book: Drug discovery and evaluation: methods in clinical pharmacology:1–54
New Drugs and Clinical Trials Rules (2019). https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf
Food and Drug Administration (2004). Comparison chart of FDA and EPA Good Laboratory Practice (GLP) regulations and the OECD principles of GLP. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/comparison-chart-fda-and-epa-good-laboratory-practice-glp-regulations-and-oecd-principles-glp
ICH M3(R2) (2009) Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals M3 (R2). In: International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use
Cwiertniewicz J (2005) Introduction to the good laboratory practice regulations. Lab Anim 34(3):29–32
ECHA. REACH tests need to comply with good laboratory practice. https://echa.europa.eu/-/reach-tests-need-to-comply-with-good-laboratory-practice
Gad SC (2016) Drug safety evaluation. Wiley, New York, NY
Chorghade MS (ed) (2007) Drug discovery and development, Volume 2: Drug development, Wiley
Takenaka T (2001) Classical vs reverse pharmacology in drug discovery. BJU Int 88:7–10
Hughes JP, Rees S, Kalindjian SB, Philpott KL (2011) Principles of early drug discovery. Br J Pharmacol 162(6):1239–1249
Russell C, Rahman A, Mohammed AR (2013) Application of genomics, proteomics and metabolomics in drug discovery, development and clinic. Ther Deliv 4(3):395–413
Andrade EL, Bento AF, Cavalli J, Oliveira SK, Schwanke RC, Siqueira JM et al (2016) Non-clinical studies in the process of new drug development-Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies. Braz J Med Biol Res 49(12):e5646
Sahota PS, Popp JA, Hardisty JF, Gopinath C (eds) (2013) Toxicologic pathology: nonclinical safety assessment. CRC Press, Boca Raton, FL
Food and Drug Administration. A history of the FDA and drug regulation in the United States. https://www.fda.gov/media/73549/download
Rahalkar H (2012) Historical overview of pharmaceutical industry and drug regulatory affairs. Pharmaceut Reg Aff S11:002
Vargesson N (2015) Thalidomide-induced teratogenesis: History and mechanisms. Birth Defects Res C Embryo Today 105(2):140–156
Kelsey FO (1988) Thalidomide update: regulatory aspects. Teratology 38(3):221–226
Schneider K (1983) Faking it. The Case against Industrial Bio-Test Laboratories. Amic J 4:14–26
Baldeshwiler AM (2003) History of FDA good laboratory practices. Qual Assur J 7(3):157–161
Weinberg S (ed) (2007) Good laboratory practice regulations. CRC Press
FDA. Good laboratory practices for nonclinical laboratory studies. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58&showFR=1
Seiler JP (2005) Good laboratory practice: the why and the how. Springer Science & Business Media
OECD (1981) Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals. [C(81)30]
OECD (1997) OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring. https://www.oecd-ilibrary.org/environment/oecd-series-on-principles-of-good-laboratory-practice-and-compliance-monitoring_2077785x
OECD (1994) OECD Guidelines for the Testing of Chemicals. https://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
OECD (1997) Decision of Council Concerning the Adherence of non-Member countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals. [C(97)114]
NGCMA. https://dst.gov.in/ngcma
EMA (European Medicines Agency) Good laboratory practice compliance. https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-laboratory-practice-compliance
Jawahar N, Lakshmi VT (2017) Regulatory requirements for the drug approval process in US, Europe and India. J Pharm Sci Res 9(10):1943–1952
Guidance document on toxicology for registration of Chemical pesticides in India, September 2017., http://ppqs.gov.in/sites/default/files/toxguidancedocsept2017.pdf
PMDA (Pharmaceuticals and Medical Devices Agency) Ministerial ordinance on Good Laboratory Practice for nonclinical safety studies of drugs. https://www.pmda.go.jp/files/000153713.pdf
Turnheim D (1993) Benefits of good laboratory practice as a tool to improve testing. Hum Exp Toxicol 12(6):528–532
Hickman S, Ogilvie B, Patterson T (2018) To GLP or not to GLP? Drug Discov 19:61
Carson, P. A., Dent, N. J. (Eds.). (2007) Good clinical, laboratory and manufacturing practices: techniques for the QA professional. Royal Society of Chemistry
OECD Document No. 21 (2020) OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies
OECD Document No. 8 (1999) The Role and Responsibilities of the Study Director in GLP Studies
OECD Document No. 13 (2002) The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies
OECD.Document No. 19 (2018) Advisory document of the working group on good laboratory practice on the management, Characterisation and use of test items
OECD Document No. 4 (1999) Quality Assurance and GLP
World Health Organization (2010) Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development. World Health Organization
Stiles T (1997) The revised OECD principles of good laboratory practice. a reflection upon the impact of the proposed changes on pre-clinical safety testing: Part 1: Scope, definition of terms, responsibilities. Qual Assurance J Qual Assurance J Pharmaceut Health Environ Prof 2(1):13–18
Heinz-Taheny K (2013) Pathology and GLPs, quality control and quality assurance. In: Haschek and Rousseaux's Handbook of toxicologic pathology. Academic Press, pp 519–536
Boverhof DR, Chamberlain MP, Elcombe CR, Gonzalez FJ, Heflich RH, Hernandez LG et al (2011) Transgenic animal models in toxicology: historical perspectives and future outlook. Toxicol Sci 121(2):207–233
Nohmi T, Masumura K, Toyoda-Hokaiwado N (2017) Transgenic rat models for mutagenesis and carcinogenesis. Genes Environ 39(1):1–32
CPCSEA. CPCSEA guidelines for laboratory animal facility, India http://cpcsea.nic.in/WriteReadData/userfiles/file/SOP_CPCSEA_inner_page.pdf
National Research Council (US) (2011) Guide for the care and use of laboratory animals, 8th edn. National Academies Press (US), Washington, DC
Canadian Council on Animal Care (2003) Guidelines on: laboratory animal facilities — characteristics, design and development. (as revised 2020) https://www.ccac.ca/Documents/Standards/Guidelines/Facilities.pdf,
Deshmukh P (2018) Animal research facility for conducting GLP study. MOJ Toxicol 4(3):205–207
European Commission Guidance Document for GLP inspectors and GLP Test Facilities (2004) Cross-contamination of control samples with test item in animal studies
OECD (2008) Repeated Dose 28-day Oral Toxicity Study in Rodents. OECD Guidelines for the Testing of Chemicals. Section 4: Health Effects
Prichett-Corning, K. R., Shek, W. R., Henderson, K. S., Clifford, C. B. (2009) Companion guide to rodent health surveillance for research facilities (No. 636.02 COM)
World Health Organization (2010) Good laboratory practice training manual: for the trainee: a tool for training and promoting Good Laboratory Practice (GLP) Concepts in Disease Endemic Countries. World Health Organization
OECD Document No. 5 (1999) Compliance of Laboratory Suppliers with GLP Principles
OECD Document No. 14 (2004) The Application of the Principles of GLP to in vitro studies
Borgert CJ, Becker RA, Carlton BD, Hanson M, Kwiatkowski PL, Sue Marty M, Witorsch RJ (2016) Does GLP enhance the quality of toxicological evidence for regulatory decisions? Toxicol Sci 151(2):206–213
Wallace JM, Trundy RL (2018) Animal research pathology: regulatory and safety considerations. ILAR J 59(1):111–118
OECD Document No 16 (2014) Guidance on the GLP Requirements for Peer Review of Histopathology
Seaton M (2014) The study pathologist’s role in GLP studies: a regulator’s perspective. Toxicol Pathol 42(1):285–285
Becker RA, Janus ER, White RD, Kruszewski FH, Brackett RE (2009) Good laboratory practices and safety assessments. Environ Health Perspect 117(11):A482–A483
OECD document No. 18 (2016) OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025
OECD Harmonised Templates for reporting chemical test summaries. http://www.oecd.org/ehs/templates/
Bolon B, Baze W, Shilling CJ, Keatley KL, Patrick DJ, Schafer KA (2018) Good laboratory practice in the academic setting: fundamental principles for nonclinical safety assessment and GLP-compliant pathology support when developing innovative biomedical products. ILAR J 59(1):18–28
Jena GB, Chavan S (2017) Implementation of Good Laboratory Practices (GLP) in basic scientific research: translating the concept beyond regulatory compliance. Regul Toxicol Pharmacol 89:20–25
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Srinivasan, K., Tikoo, K., Jena, G.B. (2021). Good Laboratory Practice (GLP) Requirements for Preclinical Animal Studies. In: Nagarajan, P., Gudde, R., Srinivasan, R. (eds) Essentials of Laboratory Animal Science: Principles and Practices. Springer, Singapore. https://doi.org/10.1007/978-981-16-0987-9_27
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