Regulatory acceptability of the minipig in the development of pharmaceuticals, chemicals and other products

Journal of Pharmacological and Toxicological Methods

Volumn 62, Issue 3, 2010, Pages 184-195

  van der Laan, Jan Willem ^a   Brightwell, John ^b   McAnulty, Peter ^c   Ratky, Joszef ^d   Stark, Claudia ^a  

^a NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^b Research Toxicology Centre   (Italy)

^c Research Institute for Animal Breeding and Nutrition ^*

^d BAYER PHARMA AG   (Germany)

Author keywords

Agrochemicals; Biocides; Food additives; Medical devices; Minipigs; Pharmaceuticals

Indexed keywords

AGRICULTURAL CHEMICAL; ANTHELIOS SX; ANTIGESTAGEN; AVOBENZONE; BIOCIDE; CHEMICAL AGENT; COSMETIC; CYTOTOXIC AGENT; DERMATOLOGICAL AGENT; ECAMSULE; EFLORNITHINE; FLUOCINOLONE ACETONIDE; FOOD ADDITIVE; HYDROQUINONE; MELOXICAM; OCTOCRYLENE; PIMECROLIMUS; PRAMIPEXOLE; RETINOIC ACID; TRI LUMA; UNCLASSIFIED DRUG; VERTEPORFIN;

ARTICLE; BLOOD TOXICITY; CARCINOGENICITY; CARDIOTOXICITY; DOG; ECONOMIC EVALUATION; FETOTOXICITY; GASTROINTESTINAL TOXICITY; HUMAN; MINIPIG; NONHUMAN; OMNIVORE; PRIMATE; REPRODUCTIVE TOXICITY; SPECIES IDENTIFICATION; TERATOGENICITY; TOXICITY TESTING; TOXICOKINETICS;

ANIMAL USE ALTERNATIVES; ANIMALS; ANIMALS, LABORATORY; DEVICE APPROVAL; DRUG APPROVAL; EQUIPMENT AND SUPPLIES; EUROPEAN UNION; FEMALE; FOOD SAFETY; GOVERNMENT REGULATION; HUMANS; MALE; MODELS, ANIMAL; SWINE; SWINE, MINIATURE; TOXICITY TESTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; XENOBIOTICS;

ANIMALIA; CANIS FAMILIARIS; PRIMATES; RODENTIA; SUIDAE;

EID: 77957222269     PISSN: 10568719     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vascn.2010.05.005     Document Type: Article

References (103)

1. Abril R., Garrett J., Zeller S.G., Sander W.G., Mast R.W. Safety assessment of DHA-rich microalgae from Schizochytrium sp. Part V: Target animal safety/toxicity study in growing swine. Regul. Toxicol. Pharmacol. 2003, 37:73-82.
2. Ahrens F., Hagemeister H., Pfeuffer M., Barth C.A. Effects of oral and intracecal pectin administration on blood lipids in minipigs. The Journal of Nutrition 1986, 116:70-76.
3. Ahrens F., Pfeuffer M., Hagemeister H., Barth C.A. The hypocholesterolemic effect of guar gum depends on dietary sucrose - Studies in minipigs. Zeitschrift für Ernährungswissenschaft 1991, 30:109-117.
4. Baekey P.A., Cerda J.J., Burgin C.W., Robbins F.L., Rice R.W., Baumgartner T.G. Grapefruit pectin inhibits hypercholesterolemia and atherosclerosis in miniature swine. Clinical Cardiology 1988, 11:597-600.
5. Bass A.S., Tomaselli G., Bullingham R., Kinter L.B. Drugs effects on ventricular repolarization: A critical evaluation of the strengths and weaknesses of current methodologies and regulatory practices. Journal of Pharmacological and Toxicological Methods 2005, 52:12-21.
6. Bauman W.A., Yalow R.S. Transplacental passage of insulin complexed to antibody. Proc. Nat Acad. Sci. USA 1981, 78:4588-4590.
7. Berggren, K.F., Møller Jensen, M. and Brück Bøgh, I., 2008. The incidence of external and visceral congenital malformations in the Göttingen minipig. (Baggrundsincidensen af eksterne og viscerale kongenitale misdannelser i Göttingen minigrise). Veterinary Thesis University of Copenhagen, January 2008 (in Danish).
8. Bertelsen H., Jensen B.B., Buemann B. D-Tagatose - A novel low calorie bulk sweetener with prebiotic properties. World Review of Nutrition and Dietetics 1999, 85:98-109.
9. Bode G., Clausing P., Gervais F., Loegsted J., Luft J., Nogues V., Sims J. under the auspices of the Steering Group of the RETHINK Project (2010), The utility of the minipig as an animal model in regulatory toxicology. Journal Pharm Tox Methods 2010, 62:196-220. (this issue).
10. Bolliger C.T., et al. Evaluation of a new self-expandable silicone stent in an experimental tracheal stenosis. Chest 1999, 115:496-501.
11. Butterworth K.R., Gaunt I.F., Grasso P., Gangolli S.D. Short-term toxicity of erythrosine BS in pigs. Food and Cosmetics Toxicology 1976, 14:533-536.
12. Cerda J.J., Normann S.J., Sullivan M.P., Burgin C.W., Robbins F.L., Vathada S., et al. Inhibition of atherosclerosis by dietary pectin in microswine with sustained hypercholesterolemia. Circulation 1994, 89:1247-1253.
13. Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. Official Journal L 262, 27.9.1976, pp. 169.
14. CPMP/SWP/1997/96: note for guidance on the pre-clinical evaluation of anticancer medicinal products, European Medicines Evaluation Agency, London, 1998. (Now being replaced by EMEA/CHMP/ICH/646107/2008 Note for Guidance on Nonclinical Evaluation for Anticancer Pharmaceuticals, European Medicines Evaluation Agency, London, November 2009).
15. Crafts R.C. The effects of estrogens on the bone marrow of adult female dogs. Blood 1948, 3:276-285.
16. D'Cruz O.J., Erbeck D., Uckun F.M. A study of the potential of the pig as model for the vaginal irritancy of benzalkonium chloride in comparison to the non-irritant microbiocide PHI-443 and the spermicide vanadocene dithiocarbamate. Toxicologic Pathology 2005, 33:465-476.
17. Damm Jørgensen K. Minipig in reproduction toxicology. Scand J Lab Anim Sci 25 Suppl. 1998, 1:63-75.
18. Damm Jørgensen K. Teratogenic activity of tretionoin in the Gottingen minipig. Scand J Lab Anim Sci 25 Suppl. 1998, 1:235-243.
19. Damm Jørgensen K., Ellegaard L., Klastrup S., Svendsen O. Haematological and clinical chemical values in pregnant and juvenile Gottingen minipigs. Scand J Lab Anim Sci 25 Suppl. 1998, 1:181-190.
20. Damm Jørgensen K., Kledal T.S.A., Svendsen O., Skakkebæk N.E. The Gottingen minipig as a model for studying effects on male fertility. Scand J Lab Anim Sci 25 Suppl. 1998, 1:161-169.
21. Dressler W.E., Appelqvist T. Plasma/blood pharmacokinetics and metabolism after dermal exposure to para-aminophenol or para-phenylenediamine. Food and Chemical Toxicology 2006, 44:371-379.
22. Drochner W., Kerler A., Zacharias B. Pectin in pig nutrition, a comparative review. J. Anim. Physiol. Anim. Nutr. (Berl.) 2004, 88:367-380.
23. Earl F.L., Tegeris A.S., Whitmore G.E., Morison R., Fitzhugh O.G. Use of swine in drug toxicity studies. Ann N Y Acad Sci 1964, 111:671-688.
24. EC, 2009. Revision of Directive 86/609/EEC on the protection of Animals used for Experimental and other scientific purposes. http://ec.europa.eu/environment/chemicals/lab_animals/revision_en.htm.
25. Ellegaard L., Cunningham A., Edwards S., Grand N., Nevalainen T., Prescott M., Schuurman T. under the auspices of the Steering Group of the RETHINK Project (2010), Welfare of the minipig with special reference to use in regulatory toxicology studies. Journal Pharm Tox Methods 2010, 62:167-183. (this issue).
26. EMEA/CHMP/SWP/169215/2005, Guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications, European Medicines Evaluation Agency, London, 29 September 2005.
27. Faber J.J., Thornburg K.L. Placental physiology, structure and function of fetomaternal exchange 1983, Raven Press, New York, 192pp.
28. Forster R., Bode G., Ellegaard L., van der Laan J.-W. The RETHINK project, mini-pigs as models for the toxicity testing of new medicines and chemicals: an impact assessment. Journal Pharm Tox Methods 2010, 62:158-159. (this issue).
29. Forster R., Bode G., Ellegaard L., van der Laan J.-W. The RETHINK project on minipigs in the toxicity testing of new medicines and chemicals: conclusions and recommendations. Journal Pharm Tox Methods 2010, 62:236-242. (this issue).
30. Fuchimoto Y., et al. Relationship between chimerism and tolerance in a kidney transplantation model. Journal of Immunology 1999, 162:5704-5711.
31. Fujishiro M., Yahagi N., Kashimura K., Matsuura T., Nakamura M., Kakushima N., et al. Tissue damage of different submucosal injection solutions for EMR. Gastrointestinal Endoscopy 2005, 62:933-942.
32. Gaunt I.F., Butterworth K.R., Grasso P., Hooson J. Short-term toxicity of yellow 2G in pigs. Food and Cosmetics Toxicology 1975, 13:1-5.
33. Gaunt I.F., Colley J., Creasey M., Grasso P. Short-term toxicity of Black PN in pigs. Food and Cosmetics Toxicology 1969, 7:557-563.
34. Gaunt I.F., Grasso P., Kiss I.S., Gangolli S.D. Short-term toxicity study on Carmoisine in the miniature pig. Food and Cosmetics Toxicology 1969, 7:1-7.
35. Gaunt I.F., Hall D.E., Grasso P., Goldberg L. Studies on Brown FK. V. Short-term feeding studies in the rat and pig. Food. Cosmet. Toxicol. 1968, 6:301-312.
36. Gaunt I.F., Kiss I.S., Grasso P., Gangolli S.D. Short-term toxicity study on Sunset Yellow FCF in the miniature pig. Food and Cosmetics Toxicology 1969, 7:9-16.
37. Gaunt I.F., Kiss I.S., Grasso P., Gangolli S.D. Short-term toxicity study on Indigo Carmine in the pig. Food and Cosmetics Toxicology 1969, 7:17-24.
38. Gollackner B., et al. Spleen transplantation in miniature swine: Surgical technique and results in major histocompatibility complex-matched donor and recipient pairs. Transplantation 2003, 75:1799-1806.
39. Greenwood-van Meerveld B., Neeley D.E., Tyler K.R., Peters L.J., McRorie J.W. Comparison of effects of colonic motility and stool characteristics associated with feeding olestra and wheat bran to ambulatory mini-pigs. Digestive Diseases and Sciences 1999, 44:1282-1287.
40. Grundschober F. Toxicological assessment of flavouring esters. Toxicology 1977, 8:387-390.
41. Gupta V.K., Zatz J.L., Rerek M. Percutaneous absorption of sunscreens through micro-Yucatan pig skin in vitro. Pharmaceutical Research 1999, 16:1602-1607.
42. Hamlin R.L. Non-drug-related electrocardiographic features in animal models in safety pharmacology. Journal of Pharmacological and Toxicological Methods 2005, 52:60-76.
43. Hansen E.V., Meyer O., Olsen P. Study of toxicity of butylated hydroxyanisole (BHA) in pregnant gilts and their foetuses. Toxicology 1982, 23:79-83.
44. Hansen E.V., Wurtzen G., Sondergaard D., Skydsgaard P. A short term peroral study of the food colour, Ponceau 6R in pigs. Toxicology 1978, 10:363-368.
45. Harrison A.P., Erlwanger K.H., Elbrønd V.S., Andersen N.K., Unmack M.A. Gastrointestinal-tract models and techniques for use in safety pharmacology. Journal of Pharmacological and Toxicological Methods 2004, 49:187-199.
46. Hart J.E. Endocrine pathology of estrogens: Species differences. Pharmacology & Therapeutics 1990, 47:203-218.
47. Hart S.G.E. Assessment of renal injury in vivo. J Pharmacol Toxicol 2005, 52:30-45.
48. Hendy R.J., Butterworth K.R., Gaunt I.F., Hooson J., Grasso P. Short-term toxicity study of Chocolate brown HT in pigs. Toxicology 1978, 11:189-192.
49. Hori N., Fujii M., Ikegami K., Momose D., Saito N., Matsumoto M. Effect of UV-absorbing agents on photodegradation of tranilast in oily gels. Chem. Pharm. Bull. (Tokyo) 1999, 47:1713-1716.
50. Jacobs A. Use of non-traditional animals for evaluation of pharmaceutical products. Exp. Opin. Drug Metab. Toxicol. 2006, 2:345-349.
51. Jochims K., Kemkowski J., Nolte T., Bartels T., Heusener A. Local tolerance testing of parenteral drugs: How to put into practice. Reg Toxicol Pharmacol 2003, 38:166-182.
52. Kieschlichova E., et al. Hemodynamic parameters in a surgical devascularisation model of fulminant hepatic failure in the minipig. Physiological Research 2005, 54:485-490.
53. Lehmann H. The minipig in general toxicology. Scand J Lab Anim Sci 1998, 25(Suppl 1):59-62.
54. Lind N.M., Moustgaard A., Jelsing J., Vajta G., Cumming P., Hansen A.K. The use of pigs in neuroscience: Modeling brain disorders. Neuroscience and Biobehavioural Reviews 2007, 31:728-751.
55. Liu L.S., Fishman M.L., Hicks K.B., Kende M. Interaction of various pectin formulations with porcine colonic tissues. Biomaterials 2005, 26:5907-5916.
56. Mahl J.A., Vogel B.E., Court M., Kolopp M., Roman D., Nogues V. The minipig in dermatotoxicology: Methods and challenges. Experimental and Toxicologic Pathology 2006, 57:341-345.
57. Matsumoto K., et al. Inhibition of neointima by angiotensin-converting enzyme inhibitor in porcine coronary artery balloon-injury model. Hypertension 2001, 37:270-274.
58. McRorie J., Brown S., Cooper R., Givaruangsawat S., Scruggs D., Boring G. Effects of dietary fibre and olestra on regional apparent viscosity and water content of digesta residue in porcine large intestine. Alimentary Pharmacology & Therapeutics 2000, 14:471-477.
59. Mortensen J.T., Brinck P., Lichtenberg J. The minipig in dermal toxicology. A literature review. Scand J Lab Anim Sci 1998, 25(Suppl 1):77-83.
60. Murphy D.J. Assessment of respiratory function in safety pharmacology. Fundamental & Clinical Pharmacology 2002, 16:183-196.
61. Nofre C., Glaser D., Tinti J.M., Wanner M. Gustatory responses of pigs to sixty compounds tasting sweet to humans. J. Anim. Physiol. Anm. Nutr. (Berl.) 2002, 86:90-96.
62. O'Goshi K.I., Tabata N., Sato Y., Tagami H. Comparative study of the efficacy of various moisturizers on the skin of the ASR miniature swine. Skin Pharmacology and Applied Skin Physiology 2000, 13:120-127.
63. OECD 428: OECD guideline for testing of chemicals - Skin absorption: In vitro method, OECD, Paris, adopted 13 April 2004.
64. Olsen P. The carcinogenic effect of butylated hydroxyanisole on the stratified epithelium of the stomach in rat versus pig. Cancer Letters 1983, 21:115-116.
65. Olsen P., Hansen E. Bile duct proliferation in pigs fed the food colour Orange RN. Acta Pharmacol.Toxicol. (Copenh.) 1973, 32:314-316.
66. Peters T. Pigs/Minipigs as the second species in toxicology studies - A regulatory perspective 2007, Presentation at the European Society of Toxicological Pathology, Copenhagen.
67. Post M.J., et al. Arterial remodeling after balloon angioplasty or stenting in an atherosclerotic experimental model. Circulation 1997, 96:996-1003.
68. Poulsen E. Short-term peroral toxicity of undegraded carrageenan in pigs. Food and Cosmetics Toxicology 1973, 11:219-227.
69. Rangarajan M., Zatz J.L. Kinetics of permeation and metabolism of alpha-tocopherol and alpha-tocopheryl acetate in micro-Yucatan pig skin. Journal of Cosmetic Science 2001, 52:35-50.
70. Rangarajan M., Zatz J.L. Effect of formulation on the delivery and metabolism of alpha-tocopheryl acetate. Journal of Cosmetic Science 2001, 52:225-236.
71. Rangarajan M., Zatz J.L. Effect of formulation on the topical delivery of alpha-tocopherol. Journal of Cosmetic Science 2003, 54:161-174.
72. Ranklove L.B., Kaae Thorhuage M.M., Eriksen C.S., Glerup P. The use of minipig for testing the local intranasal toxicity of fentanyl. Scand J Lab Animal Sci 2006, 33:1-5.
73. SCCNFP (1997a) Opinion of the Scientific Committee on Cosmetology concerning 5-tert-butyl-1, 2, 3-trimethyl-4, 6-dinitrobenzene by the Plenary Session of the SCC of 24 June 1997 (Musk Tibetene). XXIV/1430/96.
74. SCCNFP (1997b) Opinion of the Scientific Committee on Cosmetology Concerning 4, 6-dinitro-1, 1, 3, 3, 5-pentamethylindane by the Plenary Session of the SCC of 24 June 1997 (Musk Moskene). XXIV/1431/96, rev.: June 97.
75. SCCNFP (2002) Opinion of the Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers - Concerning 6-acetyl-, 1, 1, 2, 4, 4, 7 hexamethyltetraline (AHTN). SCCNFP/0609/02, final.
76. SCCNFP (2003a) The SCCNFP's notes of guidance for the testing of cosmetic ingredients and their safety evaluation, 5th Revision. Adopted during the 25th Plenary Meeting of 20 October 2003, SCCNFP/0690/03 final.
77. SCCNFP (2003b) Opinion concerning basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients, updated October 2003. SCCNFP/0750/03.
78. SCCNFP (2004a) Opinion of the Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers - Concerning curry red. SCCNFP/0791/04.
79. SCCNFP (2004b) Opinion of the Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers - Concerning HC Blue 15. SCCNFP/0793/04.
80. SCCNFP (2004c) Opinion of the Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers - Concerning methylisothiazolinone. SCCNFP/0805/04.
81. Schein P.S. Preclinical toxicology of anticancer agents. Cancer Research 1977, 37:1934-1937.
82. SCHER Scientific opinion on the need for human primates in biomedical research http://ec.europa.eu/environment/chemicals/lab_animals/pdf/scher_o_110.pd f.
83. Schwartsmann G., Wingrad B., Pinedo H.M. The main steps in the development of anticancer agents. Radiotherapy and oncology 1988, 12:301-313.
84. Smulders D., Verbeke G., Mormède P., Geers R. Validation of a behavioral observation tool to assess pig welfare. Physiology & Behavior 2006, 89:438-447.
85. Sondergaard D., Hansen E.V., Wurtzen G. A short-term study in the pig of the effects on the liver and on the blood of eight azo dyes. Toxicology 1977, 8:381-386.
86. Stegink L.D., Brummel M.C., Boaz D.P., Filer L.J. Monosodium glutamate metabolism in the neonatal pig: Conversion of administered glutamate into other metabolites in vivo. The Journal of Nutrition 1973, 103:1146-1154.
87. Stegink L.D., Filer L.J., Baker G.L. Monosodium glutamate metabolism in the neonatal pig: Effect of load on plasma, brain, muscle and spinal fluid free amino acid levels. The Journal of Nutrition 1973, 103:1138-1145.
88. Steiling W., Kreutz J., Hofer H. Percutaneous penetration/dermal absorption of hair dyes in vitro. Toxicol. in Vitro 2001, 15:565-570.
89. Stephan-Gueldner M., Inomata A. Coronary arterial lesions induced by endothelin antagonists. Toxiciol Letters 2000, 112-113:531-535.
90. Stubhan M., Markert M., Mayer K., Trautmann T., Klumpp A., Henke J., et al. Evaluation of cardiovascular and ECG parameters in the normal, freely moving Göttingen minipig. Journal of Pharmacological and Toxicological Methods 2008, 57:202-211.
91. Svendsen O. The minipig in toxicology. Experimental and toxicologic pathology 2006, 57:335-339.
92. Swindle M.M., Smith A.C. Comparative anatomy and physiology of the pig. Scand J Lab Anim Sci 1998, 25(Suppl 1):11-21.
93. U.S.Food and Drug Administration Cosmetics handbook 1992, FDA Center for Food Safety & Applied Nutrition, Office of Cosmetics and Colors, College Park, MD, USA.
94. U.S.Food and Drug Administration Redbook 2000: Toxicological principles for the safety assessment of food ingredients 2003, FDA Center for Food Safety & Applied Nutrition, Office of Food Additive Safety, College Park, MD, USA.
95. U.S.Food and Drug Administration FDA authority over cosmetics 2005, FDA Center for Food Safety & Applied Nutrition, Office of Cosmetics and Colors, College Park, MD, USA.
96. U.S.Food and Drug Administration Animal testing, April 5, 2006 revision 2006, FDA Center for Food Safety & Applied Nutrition, Office of Cosmetics and Colors, College Park, MD, USA.
97. U.S.National Research Council Nutrient requirements of swine: 10th revised edition 1998, NRC Subcommittee on Swine Nutrition, Committee on Animal Nutrition, Washington DC, USA.
98. Wang A., Seki T., Yuan D., Saso Y., Hosoya O., Chono S., et al. Effect of camellia oil on the permeation of flurbiprofen and diclofenac sodium through rat and pig skin. Biological & Pharmaceutical Bulletin 2004, 27:1476-1479.
99. Warner A.E., Barry B.E., Brain J.D. Pulmonary intravascular macrophages in sheep: Morphology and function of a novel constituent of the mononuclear phagocyte system. Lab Invest 1986, 55:276-288.
100. Wiest D.B., Swindle M.M., Garner S.S., Smith A.C., Gillette P.C. Pregnant Yucatan miniature swine as a model for investigating fetal drug therapy. Advances in swine in biomedical research 1996, 629-635. Plenum press, New York. M.E. Tumbleson, L.B. Schook (Eds.).
101. Witkamp R.F., Monshouwer M. Pharmacokinetics in vivo and vitro in swine. Scand J Lab Anim Sci 1998, 25(Suppl 1):45-56.
102. World Health Organisation (WHO) Guidelines for the preparation of toxicological working papers for the Joint FAO/WHO Expert Committee on Food Additives 2000, WHO, Geneva, Switzerland.
103. Wurtzen G., Olsen P. BHA study in pigs. Food and Chemical Toxicology 1986, 24:1229-1233.