1,458
Views
47
CrossRef citations to date
0
Altmetric
Reviews

Nonclinical strategy considerations for safety pharmacology: evaluation of biopharmaceuticals

, PhD, &
Pages 91-102 | Published online: 21 Nov 2012

Bibliography

  • ICH S6(R1). Preclinical safety evaluation of biotechnology-derived biopharmaceuticals. 2011. Available from: http://www.ich.org [Retrieved February 2012]
  • Leader B, Baca QJ, Golan DE. Protein therapeutics: a summary and pharmacological classification. Nat Rev 2008;7:21-39
  • Dixit R, Iciek LA, McKeever K, Challenges of general safety evaluations of biologics compared to small molecule pharmaceuticals in animal models. Expert Opin Drug Discov 2010;5:79-94
  • Crommelin DJA, Storm G, Verrijk R, Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm 2003;266:3-16
  • Gosse ME, DiMasi JA, Nelson TF. Recombinant protein and therapeutic monoclonal antibody drug development in the United States from 1980-1994. Clin Pharmacol Ther 1996;60:608-18
  • Reichert JM. New biopharmaceutical in the USA: trends in development and approvals 1995-1999. Trends Biotech 2000;18:364-9
  • Tsuji K, Tsutani K. Approval of new biopharmaceuticals 1999-2006: comparison of US, EU and Japan situations. Eur J Pharm Biopharm 2008;68:496-502
  • Trusheim MR, Aitkin ML, Berndt ER. Characterizing markets for biopharmaceutical innovation: do biologics differ from small molecules? Forum Health Econ Policy 2010;13:1-45
  • DiMasi JA, Feldman L, Seckler A, Trends associated with new drug development: success rates for investigational drugs. Clin Pharm Ther 2010;87:272-7
  • Reichert JM. Metrics for antibody therapeutics development. mAbs 2010;2:695-700
  • Reichert JM. Marketed therapeutic antibodies compendium. mAbs 2012;4:413-15
  • Tabrizi MA, Tseng CML, Roskos LK. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today 2006;11:81-8
  • Vargas HM, Bass AS, Breidenbach A, Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics. J Pharmacol Toxicol Methods 2008;58:72-6
  • Giezen TJ, Mantel-Teeuwisse AK, Straus SJJM, Safety-related regulatory actions for biologicals approved in the United States and the European Union. J Am Med Assoc 2008;300:1887-96
  • Haller CE, Cosenza ME, Sullivan JT. Safety issues specific to the clinical development of protein therapeutics. Clin Pharmacol Ther 2008;84:624-7
  • Guengerich FP. Mechanisms of drug toxicity and relevance to pharmaceutical development. Drug Metab Pharmacokinet 2011;26:3-14
  • Pugsley MK, Authier S, Curtis MJ. Principles of safety pharmacology. Br J Pharmacol 2008;154:1382-99
  • Bernton EW. Safety pharmacology: similarities and differences between small molecules and novel biopharmaceuticals. In: Cavagnaro J, editor. Preclinical safety evaluation of biopharmaceuticals: a science-based approach to facilitating clinical trials. John Wiley & Sons; Hoboken, NJ: 2008. p. 311-35
  • De Haan L. Preclinical safety considerations for the development of antibody-based therapuetics. Chapter 10 In: Trabizi MA, editors. Development of antibody-based therapuetics. Springer Science; New York: 2012
  • ICH S7A. Safety pharmacology studies for human biopharmaceuticals. 2000. Available from: http://www.ich.org [Retrieved February 2012]
  • ICH S7B. The nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human biopharmaceuticals. 2005. Available from: http://www.ich.org [Retrieved February 2012]
  • Leishman DJ, Beck TW, Dybdal N, Best practice in the conduct of key nonclinical cardiovascular assessments in drug development: current recommendations from the Safety Pharmacology Society. J Pharmacol Toxicol Methods 2011;65:93-101
  • Sun Y, Gruber M, Matsumoto M. Overview of global regulatory toxicology requirements for vaccines and adjuvants. J Pharmacol Toxicol Methods 2012;65:49-57
  • Chapman K, Pullen N, Graham M, Preclinical safety testing of biological: the significance of species relevance. Nat Drug Discov 2007;6:120-6
  • Bussiere JL. Species selection considerations for preclinical toxicology studies for biotherapeutics. Expert Opin Drug Metab Toxicol 2008;4:871-7
  • Baumann A. Foundation review: nonclinical development of biopharmaceuticals. Drug Discov Today 2009;14:1112-22
  • Olson H, Betton G, Robinson D, Concordance of the toxicity of pharmaceuticals in humans and in animals. Regul Toxicol Pharmacol 2000;32:56-67
  • Chui RW, Fosdick A, Conner R, Assessment of two external telemetry systems (PhysioJacket™ and JET™) in Beagle dogs with telemetry implants. J Pharmacol Toxicol Methods 2009;60:58-68
  • Guth BD, Bass AS, Briscoe R, Comparison of electrocardiographic analysis for risk of QT interval prolongation using safety pharmacology and toxicology studies. J Pharmacol Toxicol Methods 2009;60:107-16
  • Derakhchan K, Chui RW, Vargas HM. Evaluation of cardiac conduction disturbances using jacketed external telemetry (JET) in conscious non-human primates. J Pharmacol Toxicol Methods 2011;64:e46
  • Vargas HM, Derakhchan K, Chui RW, Evaluation of D,L-sotalol using jacketed external telemetry (JET) in conscious non-human primates over 4 weeks of evaluation. J Pharmacol Toxicol Methods 2010;64:e24-5
  • Chui RW, Derakhchan K, Vargas HM. Long-term assessment of non-human primate ECG using jacketed external telemetry (JET): evaluation of heart rate and QTc interval variation over 6 months of observation. J Pharmacol Toxicol Methods 2011;64:e45
  • Santostefano MJ, Kirchner J, Vissinga C, Off-target platelet activation in macaques unique to a therapeutic monoclonal antibody. Toxicol Sci 2012;40:899-917
  • Sarazan RD, Mittelstadt S, Guth B, Cardiovascular function in nonclinical drug safety assessment: current issues and opportunities. Int J Toxicol 2011;30:272-86
  • McMahon C, Mitchell AZ, Klein JL, Evaluation of blood pressure measurement using a miniature blood pressure transmitter with jacketed external telemetry in Cynomolgus monkeys. J Pharmacol Toxicol Methods 2010;62:127-35
  • Kaiser RA, Erwin R, Tichenor SD, Integration of cardiovascular safety pharmacology endpoints into general toxicology studies. J Pharmacol Toxicol Methods 2010;62:e30
  • Schmelting B, Neihoff M, Egner B, High-definition oscillometry: a novel technique for non-invasive blood pressure monitoring in the Cynomolgus monkey. J Med Primatol 2009;38:293-301
  • Kurtz TW, Griffin KA, Bidani AK, Recommendations for blood pressure measurement in humans and animals. Hypertension 2005;45:299-310
  • Wernick MB, Hopfner RM, Francey T, Comparison of arterial blood pressure measurements and hypertension scores obtained by use of three indirect measurement devices in hospitalized dogs. J Am Vet Med Assoc 2012;240:962-8
  • Ward G, Milliken P, Patel B, McMahon N. Comparison of non-invasive and implanted telemetric measurement of blood pressure and electrocardiogram in conscious beagle dogs. J Pharmacol Toxicol Methods 2012;66(2):106-13
  • Klein PM, Dybdal N. Trastuzumab and cardiac dysfunction: update on preclinical studies. Semin Oncol 2003;30:49-53
  • Qu Y, Fang M, Gao B, BeKm-1, a peptide inhibitor of hERG potassium currents, prolongs QTc interval in isolated rabbit hearts. J Pharmacol Exp Ther 2011;337:2-8
  • Nakazawa T, Kurokawa Kimura K, Safety assessment of biopharmaceuticals: japanese perspective on ICH S6 guideline maintenance. J Toxicol Sci 2008;33:277-82
  • Hondeghem L, De Clerck F. Preclinical cardiovascular safety evaluations of biologics. BioDrugs 2012;26:2275-82
  • Porsolt RD, Durmuller N, Castagne V, Moser P. CNS safety pharmacology. Chapter 8 In: Sietsma WK, Schwen R, editors. Nonclinical drug safety assessment: practical considerations for successful registration. FDAnews, Falls Church, VA: 2007
  • Korte S, Fuchs A, Weinbauer GF, Modified Irwin test as diagnostic tool to monitor neurobehavioral changes in monkeys. J Pharmacol Toxicol Methods 2007;56:e47
  • Gauvin DV, Baird TJ. A functional observational battery in non-human primates for regulatory-required neurobehavioral assessments. J Pharmacol Toxicol Methods 2008;58:88-93
  • Moscardo E, McPhie G, Fasdelli N, An integrated cardiovascular and neurobehavioral functional assessment in the conscious telemetered Cynomolgus monkey. J Pharmacol Toxicol Methods 2010;62:95-106
  • Pardridge WM. Blood-brain barrier drug targetting: the future of brain drug development. Mol Interv 2003;3:90-105
  • Freeman GB, Lin JC, Pons J, 39-Week toxicity and toxicokinetic study of ponezumab (PF-04360365) in cynomolgus monkeys with 12-week recovery period. J Alzheimers Dis 2012;28:531-41
  • Misra A, Ganesh S, Shah SP. Drug delivery to the central nervous system: a review. J Pharm Pharm Sci 2003;6:252-73
  • Pardridge WM. The blood brain barrier: bottleneck in brain drug development. NeuroRx 2005;2:3-14
  • Gabathuler R. Approaches to transport therapeutic drugs across the blood brain barrier to treat brain diseases. Neurobiol Dis 2010;37:48-57
  • Pan W, Kastin AJ. Why study transport of peptides and proteins at the neurovascular surface. Brain Res Rev 2004;46:32-43
  • Braen AP, Perron J, Tellier P, A 4-week intrathecal toxicity and pharmacokinetic study with trastuzumab in Cynomolgus monkeys. Int J Toxicol 2010;29:259-67
  • Yu YJ, Zhang Y, Kenrick M, Boosting brain uptake of a therapeutic antibody by reducing its affinity for a transcytosis target. Sci Transl Med 2011;3:1-8
  • Pardridge WM. Biopharmaceutical drug targeting to the brain. J Drug Target 2010;18:157-67
  • Amouzadeh H, Williamson T, Vargas HM. A review of convulsion and seizure incidence: small versus large molecule experience. J Pharmacol Toxicol Methods 2012; 66:e193
  • Anon. Guidance for industry: assessment of abuse potential of drugs. 2010. Available from: www.fda.gov
  • Hoffman W, Kallman MJ, Sgro M. Respiratory safety pharmacology. Chapter 7 In: Sietsma WK, Schwen R, editors. Nonclinical drug safety assessment: practical considerations for successful registration. FDAnews, Falls Church, VA: 2007
  • Hoymann HG. Lung function measurements in rodents in safety pharmacology studies. Front Pharmacol 2012;3:156
  • Murphy DJ. Assessment of respiratory function in safety pharmacology. Fundam Clin Pharmacol 2002;16:183-96
  • Foster CD, Hunter TC, Gibbs PH, Whole-body plethysmography in African green monkeys (Chlorocebus aethiops) with and without jackets. J Am Assoc Lab Anim Sci 2008;47:52-5
  • Authier S, Legaspi M, Gauvin D, Respiratory safety pharmacology: positive control drug responses in Sprague-Dawley rat, Beagle dogs and cynmolgus monkeys. Regul Toxicol Pharmacol 2009;55:229-35
  • Iizuka H, Sasaki K, Odagiri N, Measurement of respiratory function using whole-body plethysmography in unanesthetized and unrestrained non-human primates. J Toxicol Sci 2010;35:863-70
  • Lawler JV, Endy TP, Hensley LE, Cynomolgus macaque as an animal model for severe acute respiratory syndrome. PloS Med 2006;3:e149
  • Nalca A, Livingston VA, Garza NL, Experimental infection of cynomolgus macaques (Macaca fascicularis) with aerosolized monkeypox virus. PLoS One 2010;5:e12880
  • Chapman RW, Skeans S, Lamca J, Effect of histamine, albuterol and deep inspiration on airway and lung tissue mechanics in cynomolgus monkeys. Pulm Pharmacol Ther 2005;18:243-9
  • Skeans S, Lamca J, House A, Airway closure after antigen challenge in cynomolgus monkeys: effect of the histamine H1 receptor antagonist, chlorpeniramine maleate. Int Arch Allergy Immunol 2005;137:37-44
  • Curran AK, Skeans S, Landers D, Differential effects of dexamethasone on the proximal and distal lung response to antigen challenge in allergic cynomolgus monkeys. J Asthma 2008;45:377-81
  • Ingram-Ross JL, Curran AK, Miyamoto M, Cardiorespiratory safety evaluation in non-human primates. J Pharmacol Toxicol Methods 2012;66:114-24
  • Peerzada MM, Spiro TP, Daw HA. Pulmonary toxicities of biologicals: a review. Anticancer Drugs 2011;21:131-9
  • Whitebread S, Hamon J, Bojanic D, In vitro safety pharmacology profiling: an essential tool for successful drug development. Drug Discov Today 2005;10:1421-30
  • Kooijman M, van Meer JK, Moors EHM, Thirty years of preclinical safety evaluation of biopharmaceuticals: did scientific progress lead to appropriate regulatory guidance? Expert Opin Drug Saf 2012;11:797-801
  • Luft J, Bode G. Integration of safety pharmacology endpoints into toxicology studies. Fundam Clin Pharmacol 2002;16:91-103
  • Büttel IC, Chamberlain P, Chowers Y, Taking immunogenicity assessment of therapuetic proteins to teh next level. Biologicals 2011;39:100-9
  • Polson AG, Fuji RN. The success and limitations of preclinical studies in predicting the pharmacodynamics and safety of cell-surface-targeted biological agents in patients. Br J Pharmacol 2012;166:1600-2
  • Martin PL, Bugelski PJ. Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets. Br J Pharmacol 2012;166:806-22
  • Bugelski PJ, Martin PL. Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: cell surface targets. Br J Pharmacol 2012;166:823-46
  • Ponce R, Abad L, Amaravadi L, Immunogenenicity of biologically-derived therapuetics: assessment and interpretation of nonclinical safety studies. Regul Toxicol Pharmacol 2009;54:164-82
  • Lynch CM, Hart BW, Grewal IS. Practical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies. mAbs 2009;1:2-11
  • Chapman K, Pullen N, Conney L, Preclinical development of monoclonal antibodies: considerations for the use of non-human primates. mAbs 2009;1:505-16

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.