Current approaches to toxicity profiling in early-stage drug development
Keywords:
Toxicological studies, Drug discovery, New drugs, in-vitro, in-vivo studiesAbstract
The primary objective of this review is to explore the toxicological evaluation of new chemical entities. Toxicity testing of novel drugs plays a crucial role in the drug discovery and development process. This article highlights the various methods used for general toxicity assessment and provides an overview of toxicological profiling related to different diseases, with a focus on both in vitro and in vivo studies.
References
Hathaway C, Manthei J, Scherer C. Exclusivity strategies in the United States and European Union. Food Drug Law Inst Update. 2009 May;3:34-9.
Prajapati V, Tripathy S, Dureja H. Product lifecycle management through patents and regulatory strategies. J Med Mark. 2013 Aug;13(3):171-80.
Huang R, Southall N, Wang Y, Yasgar A, Shinn P, Jadhav A, et al. The NCGC pharmaceutical collection: a comprehensive resource of clinically approved drugs enabling repurposing and chemical genomics. Sci Transl Med. 2011 Apr 27;3(80):80ps16.
Branch SK, Agranat I. “New drug” designations for new therapeutic entities: new active substance, new chemical entity, new biological entity, new molecular entity. J Med Chem. 2014 Nov 13;57(21):8729-65.
Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov. 2004 Aug;3(8):711-6.
Preskorn SH. The stages of drug development and the human genome project: Drug discovery. J Psychiatr Pract. 2000 Nov 1;6(6):341-4.
Light DW, Warburton R. Demythologizing the high costs of pharmaceutical research. BioSocieties. 2011 Mar;6(1):34-50.
Rahman Z, Charoo NA, Akhter S, Beg S, Reddy IK, Khan MA. Nanotechnology-based drug products: science and regulatory considerations. In: Nanoscale fabrication, optimization, scale-up and biological aspects of pharmaceutical nanotechnology. Norwich (NY): William Andrew Publishing; 2018. p. 619-55.
Coles E, Cheyne H, Rankin J, Daniel B. Getting it right for every child: a national policy framework to promote children's well-being in Scotland, United Kingdom. Milbank Q. 2016 Jun;94(2):334-65.
Junod V. Drug marketing exclusivity under United States and European Union law. Food Drug Law J. 2004 Jan 1;59(4):479-518.
Anthöfer J. Drug development and critical analysis of the reliability of preclinical studies [master’s thesis]. Bonn: Universität Bonn; [year unknown].
Swink M, Song M. Effects of marketing-manufacturing integration on new product development time and competitive advantage. J Oper Manag. 2007 Jan 1;25(1):203-17.
Andrade EL, Bento AF, Cavalli J, Oliveira SK, Freitas CS, Marcon R, et al. Non-clinical studies required for new drug development—Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies. Braz J Med Biol Res. 2016 Oct 24;49.
Jordan SA, Cunningham DG, Marles RJ. Assessment of herbal medicinal products: challenges and opportunities to increase the knowledge base for safety assessment. Toxicol Appl Pharmacol. 2010 Mar 1;243(2):198-216.
Ayad MH. Rational formulation strategy from drug discovery profiling to human proof of concept. Drug Deliv. 2015 Aug 18;22(6):877-84.
Hann MM, Keserü GM. Finding the sweet spot: the role of nature and nurture in medicinal chemistry. Nat Rev Drug Discov. 2012 May;11(5):355-65.
Trenfield SJ, Madla CM, Basit AW, Gaisford S. The shape of things to come: emerging applications of 3D printing in healthcare. In: 3D printing of pharmaceuticals. Cham: Springer; 2018. p. 1-19.
Chaurasia G. A review on pharmaceutical preformulation studies in formulation and development of new drug molecules. Int J Pharm Sci Res. 2016 Jun 1;7(6):2313.
Benz KW, Neumann W. Introduction to crystal growth and characterization. Hoboken (NJ): John Wiley & Sons; 2014 Jul 28.
Griesser UJ. The importance of solvates. In: Hilfiker R, editor. Polymorphism in the pharmaceutical industry. Weinheim: Wiley-VCH; 2006. p. 211-33.
Suryanarayana C, Norton MG. X-ray diffraction: a practical approach. New York: Springer; 2013 Jun 29.
Giron D. Contribution of thermal methods and related techniques to the rational development of pharmaceuticals—part 1. Pharm Sci Technol Today. 1998 Aug 1;1(5):191-9.
Clas SD, Dalton CR, Hancock BC. Differential scanning calorimetry: applications in drug development. Pharm Sci Technol Today. 1999 Aug 1;2(8):311-20.
Cross J, Farrer D. Powder properties and their measurement. In: Cashdollar KL, Hertzberg M, editors. Dust explosions. Boston (MA): Springer; 1982. p. 115-64.
Giron D. Investigations of polymorphism and pseudo-polymorphism in pharmaceuticals by combined thermoanalytical techniques. J Therm Anal Calorim. 2001 Apr;64(1):37-60.
Reutzel-Edens SM, Newman AW. Physical characterization of hygroscopicity in pharmaceutical solids. In: Hilfiker R, editor. Polymorphism in the pharmaceutical industry. Weinheim: Wiley-VCH; 2006. p. 235-58.
Umprayn K, Mendes RW. Hygroscopicity and moisture adsorption kinetics of pharmaceutical solids: a review. Drug Dev Ind Pharm. 1987 Jan 1;13(4-5):653-93.
Callahan JC, Cleary GW, Elefant M, Kaplan G, Kensler T, Nash RA. Equilibrium moisture content of pharmaceutical excipients. Drug Dev Ind Pharm. 1982 Jan 1;8(3):355-69.
Visalakshi NA, Mariappan TT, Bhutani H, Singh S. Behavior of moisture gain and equilibrium moisture contents (EMC) of various drug substances and correlation with compendial information on hygroscopicity and loss on drying. Pharm Dev Technol. 2005 Jan 1;10(4):489-97.
Van Soest JJ, Hulleman SH, De Wit D, Vliegenthart JF. Changes in the mechanical properties of thermoplastic potato starch in relation with changes in B-type crystallinity. Carbohydr Polym. 1996 Mar 1;29(3):225-32.
Allen LV. Pharmaceutics and compounding issues in new drug development and marketing. In: Gad SC, editor. The process of new drug discovery and development. Boca Raton (FL): CRC Press; 2006. p. 395-418.
Florence AT, Attwood D. Physicochemical principles of pharmacy: in manufacture, formulation and clinical use. London: Pharm Press; 2015 Dec 1.
