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Research Article

Routes of exposure: Topical and transdermal

&
Pages 367-410 | Published online: 25 Mar 2002

REFERENCES

  • Steinberg M., Borzelleca J.F., Enters E.K., Kinoshita F.K., Loper A., Mitchell D.B., Tamulinas C.B., Weiner M.L. The Safety Committee of the International Pharmaceutical Excipients Council. A New Approach to the Safety Assessment of Pharmaceutical Excipients. Regul. Toxicol. Pharmacol. 1996; 24: 149–154, [PUBMED], [INFOTRIEVE], [CSA]
  • The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Detection of Toxicity to Reproduction for Medicinal Products. 1993.
  • ICH. Toxicity to Male Fertility; an Addendum to the ICH Tripartite Guideline on Detection of Toxicity to Reproduction for Medicinal Products. 1995.
  • ICH. Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals. 1997.
  • ICH. Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals. 1995.
  • ICH. Dose Selection for Carcinogenicity Studies of Pharmaceuticals. 1994.
  • ICH. Testing for Carcinogenicity of Pharmaceuticals. 1997.
  • Standard Test Method for Determining Subchronic Dermal Toxicity. ASTM, West Conshohocken 1996
  • International Organization for Standardization (ISO). 10993-5 Test for Cytotoxicity: In Vitro Methods. Geneva, Switzerland, 1992.
  • Organization for Economic Cooperation and Development (OECD). Guideline 406: Skin Sensitization, 1992.
  • Code of Federal Regulations (CFR). Washington DC: US Government Printing Office, Title 16, 1500.41, 1997.
  • CFR. Washington DC: US Government Printing Office, Title 21, 314.50 (d) (2) (ii), 1997.
  • CFR. Washington DC: US Government Printing Office, Title 21, 58, 1997.
  • Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration. Points to Consider in the Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives. Informal Communication under 21 CFR 10.90 (b) (9), 1996.
  • Liu J.C., Wisniewski S.J. Recent Advances in Topical Drug Delivery Systems. Transdermal and Topical Drug Delivery Systems, T.K. Ghosh, W.R. Pfister, S.I. Yum. Interpharm Press, Buffalo Grove 1997; 593–612
  • Pfister W.R. Transdermal and Dermal Therapeutic Systems: Current Status. Transdermal and Topical Drug Delivery Systems, T.K. Ghosh, W.R. Pfister, S.I. Yum. Interpharm Press, Buffalo Grove 1997; 33–112
  • Berner B., Mazzenga G.C., Otte J.H., Steffens R.J., Juang R.H., Ebert C.D. Ethanol: Water Mutually Enhanced Transdermal Therapeutic System II: Skin Permeation of Ethanol and Nitroglycerin. J. Pharm. Sci. 1989; 78: 402–407, [PUBMED], [INFOTRIEVE]
  • Harrison J.E., Watkinson A.C., Green D.M., Hadgraft J., Brain K. The Relative Effect of Azone and Transcutol on Permeant Diffusivity and Solubility in Human Stratum Corneum. Pharm. Res. 1996; 13: 542–546, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Knutson K., Krill S.L., Zhang J. Solvent-Mediated Alterations of the Stratum Corneum. J. Controlled Release 1990; 11: 93–103, [CROSSREF]
  • Kasting G.B., Francis W.R., Roberts G.E. Skin Penetration Enhancement of Triprolidine Base by Propylene Glycol. J. Pharm. Sci. 1993; 82: 551–552, [PUBMED], [INFOTRIEVE]
  • Lambert W.J., Higuchi W.I., Knutson K., Krill S.L. Dose-Dependent Enhancement Effects of Azone on Skin Permeability. Pharm. Res. 1989; 6: 798–803, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Pershing L.K., Lambert L.D., Knutson K. Mechanism of Ethanol-Enhanced Estradiol Permeation Across Human Skin In Vivo. Pharm. Res. 1990; 7: 170–175, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Tanojo H., Bouwstra J.A., Junginger H.E., Bodde H.E. In Vitro Human Skin Barrier Modulation by Fatty Acids: Skin Permeation and Thermal Analysis Studies. Pharm. Res. 1997; 14: 42–49, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Yazdanian M., Chen E. The Effect of Diethylene Glycol Monoethyl Ether as a Vehicle for Topical Delivery of Ivermectin. Vet. Res. Commun. 1995; 19: 309–319, [PUBMED], [INFOTRIEVE], [CSA]
  • Osborne D.W., Henke J.J. Skin Penetration Enhancers Cited in the Technical Literature. Pharm. Technol. 1997; 58–66, Nov.
  • Chattaraj S.C., Walker R.B. Penetration Enhancer Classification. Percutaneous Penetration Enhancers, E.W. Smith, H.I. Maibach. CRC Press, Boca Raton, FL 1995; 5–20
  • Roberts M.S., Singh J., Yoshida N., Currie K.I. Iontophoretic Transport of Selected Solutes Through Human Epidermis. Prediction of Percutaneous Penetration Methods, Measurements and Modeling, R.C. Scott, R.H. Guy, J. Hadgraft. IBC Technical Services, London 1989; 231–241, Proceedings of the conference held in April 1989
  • Sage B.H., Riviere J.E. Model Systems in Iontophoresis—Transport Efficacy. Adv. Drug Deliv. Rev. 1992; 9: 265–287, [CROSSREF]
  • Singh P., Maibach H.I. Transdermal Iontophoresis Pharmacokinetic Considerations. Clin. Pharmacokinet. 1994; 26: 327–334, [PUBMED], [INFOTRIEVE], [CSA]
  • Turner N.G., Ferry L., Price M., Cullander C., Guy R.H. Iontophoresis of Poly-l-Lysines: The Role of Molecular Weight?. Pharm. Res. 1997; 14: 1322–1331, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Meyer B.R., Kreis W., Eschbach J., O'Mara V., Rosen S., Sibalis D. Successful Transdermal Administration of Therapeutic Doses of a Polypeptide to Normal Human Volunteers. Clin. Pharmacol. Ther. 1988; 44: 607–612, [PUBMED], [INFOTRIEVE], [CSA]
  • Meyer B.R., Kreis W., Eschbach J., O'Mara V., Rosen S., Sibalis D. Transdermal Versus Subcutaneous Leuprolide: A Comparison of Acute Pharmacodynamic Effect. Clin. Pharmacol. Ther. 1990; 48: 340–345, [PUBMED], [INFOTRIEVE]
  • Ruddy S.B., Hadzija B.W. Iontophoretic Permeability of Polyethylene Glycols Through Hairless Rat Skin: Application of Hydrodynamic Theory for Hindered Transport through Liquid-Filled Pores. Drug Design Discov. 1992; 8: 207–224
  • Green P.G., Hinz R.S., Kim A., Szoka F.C., Guy R.H. Iontophoretic Delivery of a Series of Tripeptides Across the Skin In Vitro. Pharm. Res. 1991; 8: 1121–1127, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Pikal M.J., Shah S. Transport Mechanisms in Iontophoresis. III: An Experimental Study of the Contributions of Electroosmotic Flow and Permeability Change in the Transport of Low and High Molecular Weight Solutes. Pharm. Res. 1990; 7: 222–229, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Hirvonen J., Guy R.H. Iontophoretic Delivery Across the Skin; Electroosmosis and Its Modulation by Drug Substances. Pharm. Res. 1997; 14: 1258–1263, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Ruddy S.B., Hadzija B.W. The Role of Stratum Corneum in Electrically Facilitated Transdermal Drug Delivery. I: Influence of Hydration, Tape-Stripping and Delipidization on the DC Electrical Properties of Skin. J. Controlled Release 1995; 37: 225–238, [CROSSREF]
  • Elias P.M., Menon G.K. Structural and Lipid Biochemical Correlates of the Epidermal Permeability Barrier. Adv. Lipid Res. 1991; 24: 1–26, [PUBMED], [INFOTRIEVE]
  • Mitragotri S., Blankschtein D., Langer R. Transdermal Drug Delivery Using Low-Frequency Sonophoresis. Pharm. Res. 1996; 13: 411–420, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Mitragotri S., Blankschtein D., Langer R. Ultrasound-Mediated Transdermal Protein Delivery. Science 1995; 269: 850–853, [PUBMED], [INFOTRIEVE]
  • Vanbever R., Le Boulenge E., Preat V. Transdermal Delivery of Fentanyl by Electroporation. I: Influence of Electrical Factors. Pharm. Res. 1996; 13: 559–565, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Woodard D.F., Nieves A.L., Williams L.S., Spada C.S., Wawley S.B., Duenes J.L. A New Hairless Strain of Guinea Pig: Characterization of the Cutaneous Morphology and Pharmacology. Models in Dermatology, H.I. Maibach, N.J. Lowe. Karger, Basel 1989; Vol. 4: 71–78
  • Buehler E.V., Kreuzmann J.J., Sakr A., Gu X.H. Comparable Sensitivity of Hairless and Hartley Strain Guinea Pigs to a Primary Irritant and a Sensitizer. J. Toxicol. Cutan. Ocul. Toxicol. 1990; 9: 163–168
  • Chester A.E., Terrell T.G., Nave E., Dorr A.E., DePass L.R. Dermal Sensitization Study in Hairless Guinea Pigs with Dinitrochlorobenzene and Ethyl Aminobenzoate. J. Toxicol. Cutan. Ocul. Toxicol. 1988; 7: 273–281
  • Ademola J., Maibach H.I. Safety Assessment of Transdermal and Topical Dermatological Products. Transdermal and Topical Drug Delivery Systems, T.K. Ghosh, W.R. Pfister, S.I. Yum. Interpharm Press, Buffalo Grove 1997; 191–214
  • Buehler E.V. Prospective Testing for Delayed Contact Hypersensitivity in Guinea Pigs: The Buehler Method. Methods in Immunotoxicol, G.R. Burleson, J.H. Dean, A.E. Munson. Wiley-Liss, New York 1995; Vol. 2: 343–356
  • Prevo M., Cormier M., Nichols K. Predictive Toxicology Methods for Transdermal Delivery Systems. Dermatotoxicology, F.N. Marzulli, H.I. Maibach. 5th Ed., Taylor & Francis, Washington, DC 1996; 397–410
  • Guideline for Industry Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies. Federal Register (60 FR 11264), March 1, 1995.
  • Keister J.C., Kasting G.B. The Use of Transient Diffusion to Investigate Transport Pathways Through Skin. J. Controlled Release 1986; 4: 111–117, [CROSSREF]
  • Illel B., Schaefer H., Wepierre J. Follicles Play an Important Role in Percutaneous Absorption. J. Pharm. Sci. 1991; 80: 424–427, [PUBMED], [INFOTRIEVE]
  • Kao J., Hall J., Helman G. In Vitro Percutaneous Absorption in Mouse Skin: Influence of Skin Appendages. Toxicol. Appl. Pharmacol. 1988; 94: 93–103, [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
  • Rolland A., Wagner N., Chatelus A., Shroot B., Schaefer H. Site-Specific Drug Delivery to Pilosebaceous Structures Using Polymeric Microspheres. Pharm. Res. 1993; 10: 1738–1744, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Bidmon H.J., Pitts J.D., Solomon H.F., Bondi J.V., Stumpf W.E. Estradiol Distribution and Penetration in Rat Skin after Topical Application, Studied by High Resolution Autoradiography. Histochemistry 1990; 95: 43–54, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Lauer A.C., Lieb L.M., Ramachandran C., Flynn G.L., Weiner N.D. Transfollicular Drug Delivery. Pharm. Res. 1995; 12: 179–186, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Michaels A.S., Chandrasekaran S.K., Shaw J.E. Drug Permeation Through Human Skin: Theory and In Vitro Experimental Measurement. AICHE J. 1975; 21: 985–996, [CROSSREF]
  • Chandrasekaran S.K., Michaels A.S., Campbell P.S., Shaw J.E. Scopolamine Permeation Through Human Skin In Vitro. AICHE J. 1976; 22: 828–832, [CROSSREF]
  • Guy R.H., Carlstrom E.M., Bucks D.A.W., Hinz R.S., Maibach H.I. Percutaneous Penetration of Nicotinates: In Vivo and In Vitro Measurements. J. Pharm. Sci. 1986; 75: 968–972, [PUBMED], [INFOTRIEVE]
  • Friend D.R. In Vitro Skin Permeation Techniques. J. Controlled Release 1992; 18: 235–248, [CROSSREF]
  • Spencer T.S. Preclinical Assessment of Transdermal Drug Delivery Systems. Transdermal and Topical Drug Delivery Systems, T.K. Ghosh, W.R. Pfister, S.I. Yum. Interpharm Press, Buffalo Grove 1997; 167–179
  • Kasting G.B., Filloon T.G., Francis W.R., Meredith M.P. Improving the Sensitivity of In Vitro Skin Penetration Experiments. Pharm. Res. 1994; 11: 1747–1754, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Skelly J.P., Shah V.P., Maibach H.I., Guy R.H., Wester R.C., Flynn G., Yacobi A. FDA and AAPS Report of the Workshop on Principles and Practices of In Vitro Percutaneous Penetration Studies: Relevance to Bioavailability and Bioequivalence. Pharm. Res. 1987; 4: 265–267, [CROSSREF]
  • Franz T.J. Percutaneous Absorption. On the Relevance of In Vitro Data. J. Invest. Dermatol. 1975; 64: 190–195, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Rougier A., Lotte C., Maibach H.I. In Vivo Percutaneous Penetration of Some Organic Compounds Related to Anatomic Site in Humans: Predictive Assessment by the Stripping Method. J. Pharm. Sci. 1987; 76: 451–454, [PUBMED], [INFOTRIEVE]
  • Shah A.K., Wei G., Lanman R.C., Bhargava V.O., Weir S.J. Percutaneous Absorption of Ketoprofen from Different Anatomical Sites in Man. Pharm. Res. 1996; 13: 168–172, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Kasting G.B., Bowman L.A. Electrical Analysis of Fresh, Excised Human Skin: A Comparison with Frozen Skin. Pharm. Res. 1990; 7: 1141–1146, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Franz T.J., Lehman P.A. The Use of Water Permeability as a Means of Validation for Skin Integrity in In Vitro Percutaneous Absorption Studies. J. Invest. Dermatol. 1990; 95: 525
  • Kasting G.B., Bowman L.A. DC Electrical Properties of Frozen, Excised Human Skin. Pharm. Res. 1990; 7: 134–143, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Kao J., Patterson F.K., Hall J. Skin Penetration and Metabolism of Topically Applied Chemicals in Six Mammalian Species, Including Man: An In Vitro Study with Benzo[a]Pyrene and Testosterone. Toxical. Appl. Pharmacol. 1985; 81: 502–516, [CROSSREF]
  • Wester R.C., Christoffel J., Hartway T., Poblete N., Maibach H.I., Forsell J. Human Cadaver Skin Viability for In Vitro Percutaneous Absorption: Storage and Detrimental Effects of Heat-Separation and Freezing. Pharm. Res. 1998; 15: 82–84, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Raffali F., Rougier A., Roguet R. Measurement and Modulation of Cytochrome-P450 Dependent Enzyme Activity in Cultured Human Keratinocytes. Skin Pharmacol. 1994; 7: 345–354, [PUBMED], [INFOTRIEVE]
  • Coulomb B., Lebreton C., Dubertret L. The Skin Equivalent: A Model for Skin and General Pharmacology. Models in Dermatology, H.I. Maibach, N.J. Lowe. Karger, Basel 1989; Vol. 4: 20–29
  • Loper, A.E.; Michaels, A.S.; Bamopoulos, G.; Ng, L.L.; Bondi, J.V.; Cohen, E.M. Drug Transport Through Membranes from a Reservoir with Time-Dependent Diffusional Resistance. Proceedings of the 11th International Symposium of Controlled Release of Bioactive Materials, 1984.
  • Hojyo-Tomoka M.T., Kligman A.M. Does Cellophane Tape Stripping Remove the Horny Layer?. Arch. Dermatol. 1972; 106: 767–768, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Bronaugh R.L., Stewart R.F. Methods for In Vitro Percutaneous Absorption Studies. V: Permeation Through Damaged Skin. J. Pharm. Sci. 1985; 74: 1062–1066, [PUBMED], [INFOTRIEVE]
  • Turner N.G., Kalia Y.N., Guy R.H. The Effect of Current on Skin Barrier Function In Vivo: Recovery Kinetics Post-Iontophoresis. Pharm. Res. 1997; 14: 1252–1257, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Flynn G.L., Yalkowsky S.H., Roseman T.J. Mass Transport Phenomena and Models: Theoretical Concepts. J. Pharm. Sci. 1974; 63: 1276–1280, [PUBMED], [INFOTRIEVE]
  • Palm J., Ferguson F.G. Fuzzy, a Hypotrichotic Mutant in Linkage Group I of the Norway Rat. J. Hered. 1976; 67: 284–288, [PUBMED], [INFOTRIEVE]
  • Loper A.E., Grabowski L.A., Fong E.K., Wiernik M.D., Bondi J.V. Fuzzy Rat Skin as a Surrogate for Cadaver Skin for In Vitro Diffusion Studies. Pharm. Res. 1986; 3: 72S
  • Bronaugh R.L., Stewart R.F. Methods for In Vitro Percutaneous Absorption Studies. VI: Preparation of the Barrier Layer. J. Pharm. Sci. 1986; 75: 487–491, [PUBMED], [INFOTRIEVE]
  • Krueger G.G., Wojciechowski Z.J., Burton S.A., Gilhar A., Huether S.E., Leonard L.G., Rohr U.D., Petelenz T.J., Higuchi W.I., Pershing L.K. The Development of a Rat/Human Skin Flap Served by a Defined and Accessible Vasculature on a Congenitally Athymic (Nude) Rat. Fundam. Appl. Toxicol. 1985; 6: S112–S121, [CROSSREF]
  • Riviere J.E., Bowman K.F., Monteiro-Riviere N.A., Dix L.P., Carver M.P. The Isolated Perfused Porcine Skin Flap (IPPSF). Fundam. Appl. Toxicol. 1986; 7: 444–453, [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
  • Cheriathundam E., Almirez R., Alvares A.P. Comparisons of Hepatic and Renal Cytochrome P-450-Dependent Monooxygenases from Fuzzy and Sprague–Dawley Rats. Drug Metab. Dispos. 1992; 20: 19–22, [PUBMED], [INFOTRIEVE]
  • Muck W.M., Henion J.D. High-Performance Liquid Chromatography/Tandem Mass Spectrometry: Its Use for the Identification of Stanozolol and Its Major Metabolites in Human and Equine Urine. Biomed. Environ. Mass Spectrom. 1990; 19: 37–51, [PUBMED], [INFOTRIEVE]
  • Olah T.V., McLoughlin D.A., Gilbert J.D. The Simultaneous Determination of Mixtures of Drug Candidates by Liquid Chromatography/Atmospheric Pressure Chemical Ionization Mass Spectrometry as an In Vivo Drug Screening Procedure. Rapid Commun. Mass Spectrom. 1997; 11: 17–23, [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
  • Noonan P.K., Wester R.C. Cutaneous Metabolism of Xenobiotics. Percutaneous Absorption Mechanisms—Methodology—Drug Delivery, R.L. Bronaugh, H.I. Maibach. Marcel Dekker, New York 1985; 65–85
  • Bucks D.A.W. Skin Structure and Metabolism: Relevance to the Design of Cutaneous Therapeutics. Pharm. Res. 1984; 1: 148–153, [CROSSREF]
  • Martin R.J., Denyer S.P., Hadgraft J. Skin Metabolism of Topically Applied Compounds. Int. J. Pharm. 1987; 39: 23–32, [CROSSREF]
  • Loo J.C., Riegelman S. New Method for Calculating the Intrinsic Absorption Rate of Drugs. J. Pharm. Sci. 1968; 57: 918–928, [PUBMED], [INFOTRIEVE]
  • Yacobi A., Baughman R.A., Cosulich D.B., Nicolau G. Method for Determination of First-Pass Metabolism in Human Skin. J. Pharm. Sci. 1984; 73: 1499–1500, [PUBMED], [INFOTRIEVE]
  • Gillespie W.R., Veng Pedersen P. A Polyexponential Deconvolution Method. Evaluation of the Gastrointestinal Bioavailability and Mean In Vivo Dissolution Time of Some Ibuprofen Dosage Forms. J. Pharmacokinet. Biopharm. 1985; 13: 289–307, [PUBMED], [INFOTRIEVE]
  • Wagner J.G. Pharmacokinetics for the Pharmaceutical Scientist. Technomic Publishing, Lancaster 1993; 159–206
  • Guideline for Industry Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies. Federal Register 1995, 60(40), 11274–11275.
  • Brown W.R., Hardy M.H. The Asebia Mouse: An Animal Model of Psoriasiform Disease. Models in Dermatology, H.I. Maibach, N.J. Lowe. S. Karger, New York 1985; Vol. 1: 220–227
  • Puhvel S.M. Animal Models for Comedolytic Agents. Models in Dermatology, H.I. Maibach, N.J. Lowe. S. Karger, New York 1985; Vol. 2: 64–69
  • Shah V.P., Flynn G.L., Yacobi A., Maibach H.I., Bon C., Fleischer N.M., Franz T.J., Kaplan S.A., Kawamoto J., Lesko L.J., Marty J.P., Pershing L.K., Schaefer H., Sequeira J., Shrivastava S., Wilkin J., Williams R. AAPS/FDA Workshop Report Bioequivalence of Topical Dermatological Dosage Forms—Methods of Evaluation of Bioequivalence. Pharm. Technol. 1998; 140–148, March
  • Vickers C.F.H. Stratum Corneum Reservoir for Drugs. Advances in Biology of Skin, Pharmacology and the Skin, W. Montagna, E.J. Van Scott, R.B. Stoughton. Appleton-Century-Crofts, New York 1969; Vol. 12: 177–189
  • Fong E.K., Frank J.D., Cartwright M.E., Loper A.E. Improved Method for Rhesus Monkey or Rat Skin Preparation and Cryosectioning for Topical or Transdermal Skin Distribution Studies. Exp. Dermatol. 1996; 5: 45–48, [PUBMED], [INFOTRIEVE], [CSA]
  • Neelissen J.A.M. Visualization of Percutaneous Steroid Transport. Leiden University, The Netherlands 1962
  • Anderson C., Andersson T., Boman A. Cutaneous Microdialysis for Human In Vivo Dermal Absorption Studies. Dermal Absorption and Toxicity Assessment, M.S. Roberts, K.A. Walters. Marcel Dekker, New York 1998; 231–244
  • Auletta C.S. Acute, Subchronic and Chronic Toxicology. CRC Handbook of Toxicology, M.J. Derelanko, M.A. Hollinger. CRC Press, Boca Raton, FL 1995; 51–104
  • Rush R.E., Bonnette K.L., Douds D.A., Merriman T.N. Dermal Irritation and Sensitization. CRC Handbook of Toxicology, M.J. Derelanko, M.A. Hollinger. CRC Press, Boca Raton, FL 1995; 105–162
  • Lawrence J.N. Application of In Vitro Human Skin Models to Dermal Irritancy: A Brief Overview and Future Prospects. Toxicol. In Vitro 1997; 11: 305–312, [CROSSREF], [CSA]
  • Draize J.H., Woodard G., Calvery H.O. Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Ther. 1944; 82: 377–390
  • Klein-Szanto A.J.P., Conti C.J., Aldaz C.M. Skin and Oral Mucosa. Handbook of Toxicologic Pathology, W.M. Haschek, C.G. Rousseaux. Academic Press, San Diego 1991; 165–193
  • de Silva O., Basketter D.A., Barratt M.D., Corsini E., Cronin M.T.D., Das P.K., Degwert J., Enk A., Garrigue J.L., Hauser C., Kimber I., Lepoittevin J.-P., Peguet J., Ponec M. Alternative Methods for Skin Sensitisation Testing: the Report and Recommendations of ECVAM Workshop 19. ALTA 1996; 24: 683–705
  • Bour H., Krasteva M., Nicolas J.-F. Allergic Contact Dermatitis. Skin Immune System (SIS): Cutaneous Immunology and Clinical Immunodermatology, J.S. Bos. 2nd Ed., CRC Press, Boca Raton, FL 1997; 509–522
  • Gad S.C. Safety Evaluation of Medical Devices. Marcel Dekker, New York 1997; 131–188
  • Kimber I., Dearman R.J. Contact Hypersensitivity: Immunological Mechanisms. Toxicology of Contact Hypersensitivity, I. Kimber, T. Maurer. Taylor & Francis, London 1996; 4–25
  • Patrick E., Maibach H.I. Principles and Methods of Toxicology, A.W. Hayes. 3rd Ed., Raven Press, New York 1994; 767–803
  • Scheper R.J., von Blomberg B.M.E. Mechanisms of Allergic Contact Dermatitis to Chemicals. Allergic Hypersensitivities Induced by Chemicals: Recommendations for Prevention, J.G. Vos, M. Younes, E. Smith. CRC Press, Boca Raton, FL 1996; 185–201
  • Klecak G. Test Methods for Allergic Contact Dermatitis in Animals. Dermatotoxicology Methods: the Laboratory Worker's Vade Mecum, F.N. Marzulli, H.I. Maibach. Taylor & Francis, Washington DC 1998; 121–143
  • Maurer T. Guinea Pig Predictive Tests. Toxicology of Contact Hypersensitivity, I. Kimber, T. Maurer. Taylor & Francis, London 1996; 107–126
  • Prevo M., Cormier M., Matriano J. Developing a Toxicology Evaluation Plan for Transdermal Delivery Systems. Dermatotoxicology Methods: the Laboratory Worker's Vade Mecum, F.N. Marzulli, H.I. Maibach. Taylor & Francis, Washington DC 1998; 75–87
  • Maguire H.C. Estimation of the Allergenicity of Prospective Human Contact Sensitizers in the Guinea Pig. Animal Models in Dermatology, H.I. Maibach. Churchill Livingstone, New York 1975; 67–75
  • Griffith J.F. Predictive and Diagnostic Testing for Contact Sensitization. Toxicol. Appl. Pharmacol. 1969; 3: 90–102
  • Buehler E.V. Delayed Contact Hypersensitivity in the Guinea Pig. Arch. Dermatol. 1965; 91: 171–175, [PUBMED], [INFOTRIEVE]
  • Basketter D.A., Cookman G., Gerberick G.F., Hamaide N., Potokar M. Skin Sensitization Thresholds: Determination in Predictive Models. Food. Chem. Toxicol. 1997; 35: 417–425, [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
  • Haeberlin B., Friend D.R. Anatomy and Physiology of the Gastrointestinal Tract: Implications for Colonic Drug Delivery. Oral Colon-Specific Drug Delivery, D.R. Friend. CRC Press, Boca Raton, FL 1992; 1–43
  • Braun-Falco O., Korting H.C. Normal pH Value of Human Skin. Hautarzt 1986; 37: 126–129, [PUBMED], [INFOTRIEVE]
  • Matsushima D., Prevo M.E., Gorsline J. Absorption and Adverse Effects Following Topical and Oral Administration of Three Transdermal Nicotine Products to Dogs. J. Pharm. Sci. 1995; 84: 365–369, [PUBMED], [INFOTRIEVE]
  • United States Pharmacopoeia 23/National Formulary 18. Rockville, MD: United States Pharmacopoeia Convention, 1995, pp 1699–1703.
  • Freshney R.I. Measurement of Viaibility and Cytotoxicity. Culture of Animal Cells: A Manual of Basic Technique, R.I. Freshney. 3rd Ed., Wiley-Liss, New York 1994; 287–307
  • Mosmann T. Rapid Colorimetric Assay for Cellular Growth and Survival: Application to Proliferation and Cytotoxicity Assays. J. Immunol. Methods 1983; 65: 55–63, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Gad S.C. Safety Evaluation of Medical Devices. Marcel Dekker, New York 1997; 75–84
  • United States Pharmacopeia 23/National Formulary 18. Rockville, MD: United States Pharmacopeial Convention, 1995, pp 1697–1699.
  • Wier P.J., Wise L.D. Middle Atlantic Reproduction and Teratology Association: Bibliography of Reproductive and Developmental Toxicology Test Guidelines and Related Publications. Developmental Toxicology, R.D. Hood. CRC Press, Boca Raton 1997; 735–749
  • Ecobichon D.J. Reproductive Toxicology. The Basis of Toxicity Testing, D.J. Ecobichon. 2nd Ed., CRC Press, Boca Raton, FL 1997; 117–156
  • Ecobichon D.J. Reproductive Toxicology. CRC Handbook of Toxicology, M.J. Derelanko, M.A. Hollinger. CRC Press, Boca Raton, FL 1995; 379–402
  • MacKenzie K.M., Hoar R.M. Developmental Toxicology. CRC Handbook of Toxicology, M.J. Derelanko, M.A. Hollinger. CRC Press, Boca Raton, FL 1995; 403–450
  • Manson J.M., Kang Y.J. Test Methods for Assessing Female Reproductive and Developmental Toxicology. Principles and Methods of Toxicology, A.W. Hayes. 3rd Ed., Raven Press, New York 1994; 989–1037
  • Rogers J.M., Kavlock R.J. Developmental Toxicology. Casarett & Doull's Toxicology: The Basic Science of Poisons, C.D. Klaassen. 5th Ed., McGraw-Hill, New York 1996; 301–331
  • Thomas J.A. Toxic Responses of the Reproductive System. Casarett & Doull's Toxicology: The Basic Science of Poisons, C.D. Klaassen. 5th Ed., McGraw-Hill, New York 1996; 547–581
  • Kimmel C.A., Francis E.Z. Proceedings of the Workshop on the Acceptability and Interpretation of Dermal Developmental Toxicity Studies. Fundam. Appl. Toxicol. 1990; 14: 386–398, [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
  • Rogers J.M., Kavlock R.J. Developmental Toxicology. Casarett & Doull's Toxicology: The Basic Science of Poisons, C.D. Klaassen. McGraw-Hill, New York 1996; 301–331
  • Becci P.J., Knickerbocker M.J., Reagan E.L., Parent R.A., Burnette L.W. Teratogenicity Study of N-Methylpyrrolidone after Dermal Application to Sprague–Dawley Rats. Fundam. Appl. Toxicol. 1982; 2: 73–76, [PUBMED], [INFOTRIEVE]
  • Feuston M.H., Mackerer C.R. Developmental Toxicity Study in Rats Exposed Dermally to Clarified Slurry Oil for a Limited Period of Gestation. J. Toxicol. Environ. Health 1996; 49: 207–220, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Feuston M.H., Mackerer C.R., Schreiner C.A., Hamilton C.E. Systemic Toxicity of Dermally Applied Crude Oils in Rats. J. Toxicol. Environ. Health 1997; 51: 387–399, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Feuston M.H., Kerstetter S.L., Singer E.J., Mehlman M.A. Developmental Toxicity of Clarified Slurry Oil Applied Dermally to Rats. Toxicol. Ind. Health 1989; 5: 587–599, [PUBMED], [INFOTRIEVE]
  • Feuston M.H., Kerstetter S.L., Wilson P.D. Teratogenicity of 2-Methoxyethanol Applied as a Single Dermal Dose to Rats. Fundam. Appl. Toxicol. 1990; 15: 448–456, [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
  • Hoberman A.M., Christian M.S., Lovre S., Roth R., Koschier F. Developmental Toxicity Study of Clarified Slurry Oil (CSO) in the Rat. Fundam. Appl. Toxicol. 1995; 1: 34–40, [CROSSREF]
  • Seegmiller R.E., Carter M.W., Ford W.H., White R.D. Induction of Maternal Toxicity in the Rat by Dermal Application of Retinoic Acid and Its Effect on Fetal Outcome. Reprod. Toxicol. 1990; 4: 277–281, [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
  • Tyl R.W., Fisher L.C., Kubena M.F., Vrbanic M.A., Gingell R., Guest D., Hodgson J.R., Murphy S.R., Tyler T.R., Astill B.D. The Developmental Toxicity of 2-Ethylhexanol Applied Dermally to Pregnant Fischer 344 Rats. Fundam. Appl. Toxicol. 1992; 19: 176–185, [PUBMED], [INFOTRIEVE], [CROSSREF], [CSA]
  • Forbes P.D., Sambuco C.P., Dearlove G.E., Parker R.M., Kiorpes A.L., Wedig J.H. Sample Protocols for Carcinogenesis and Photocarcinogenesis. Dermatotoxicology Methods: The Laboratory Worker's Vade Mecum, F.N. Marzulli, H.I. Maibach. Taylor & Francis, Washington, DC 1998; 281–302
  • Marzulli F.N., Maibach H.I. Photoirritation (Phototoxicity, Phototoxic Dermatitis). Dermatotoxicology, F.N. Marzulli, H.I. Maibach. 5th Ed., Taylor & Francis, Washington, DC 1996; 231–237
  • Lambert L.A., Wamer W.G., Kornhauser A. Animal Models for Phototoxicity Testing. Dermatotoxicology, F.N. Marzulli, H.I. Maibach. 5th Ed., Taylor & Francis, Washington, DC 1996; 515–529
  • Forbes P.D. Carcinogenesis and Photocarcinogenesis Test Methods. Dermatotoxicology, F.N. Marzulli, H.I. Maibach. 5th Ed., Taylor & Francis, Washington, DC 1996; 535–544

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