Hayes' Principles and Methods of Toxicology, Sixth Edition
暂无分享,去创建一个
[1] L. Buckley,et al. High dose selection in general toxicity studies for drug development: A pharmaceutical industry perspective. , 2009, Regulatory toxicology and pharmacology : RTP.
[2] G. Sachs,et al. Gastric H,K-ATPase as therapeutic target. , 1988, Annual review of pharmacology and toxicology.
[3] D. G. Davey,et al. The predictive value for man of toxicological tests of drugs in laboratory animals. , 1970, British medical bulletin.
[4] P. Williams. The role of pharmacological profiling in safety assessment. , 1990, Regulatory toxicology and pharmacology : RTP.
[5] E. Hansson,et al. Toxicology Studies with Omeprazole , 1986 .
[6] Richard W. Lewis,et al. Recognition of Adverse and Nonadverse Effects in Toxicity Studies , 2002, Toxicologic pathology.
[7] J. Contrera,et al. A Systemic Exposure-Based Alternative to the Maximum Tolerated Dose for Carcinogenicity Studies of Human Therapeutics , 1995 .
[8] E J Calabrese,et al. Hormesis as a biological hypothesis. , 1998, Environmental health perspectives.
[9] James L Stevens,et al. The future of drug safety testing: expanding the view and narrowing the focus. , 2009, Drug discovery today.
[10] Samuel M Cohen,et al. Human carcinogenic risk evaluation: an alternative approach to the two-year rodent bioassay. , 2004, Toxicological sciences : an official journal of the Society of Toxicology.
[11] B. Butterworth,et al. Nongenotoxic carcinogens in the regulatory environment. , 1989, Regulatory toxicology and pharmacology : RTP.
[12] Gary W. Caldwell,et al. Allometric scaling of pharmacokinetic parameters in drug discovery: Can human CL, Vss and t1/2 be predicted fromin-vivo rat data? , 2004, European Journal of Drug Metabolism and Pharmacokinetics.
[13] D. Grahame-Smith. Preclinical toxicological testing and safeguards in clinical trials , 2004, European Journal of Clinical Pharmacology.
[14] D. Rall,et al. The evaluation of anticancer drugs in dogs and monkeys for the prediction of qualitative toxicities in man , 1970, Clinical pharmacology and therapeutics.
[15] C. Schreiner. APPLICATION OF SHORT‐TERM TESTS TO SAFETY TESTING OF INDUSTRIAL CHEMICALS , 1983, Annals of the New York Academy of Sciences.
[16] J. French,et al. The utility of genetically modified mouse assays for identifying human carcinogens: a basic understanding and path forward. The Alternatives to Carcinogenicity Testing Committee ILSI HESI. , 2004, Toxicological sciences : an official journal of the Society of Toxicology.
[17] K. G. Wormsley. Omeprazole: Gastrin and gastric data , 1991, Digestive Diseases and Sciences.
[18] F W Lee,et al. Testing paradigm for prediction of development-limiting barriers and human drug toxicity. , 2004, Chemico-biological interactions.
[19] S. Allerheiligen,et al. Concomitant Toxicokinetics: Techniques for and Interpretation of Exposure Data Obtained During the Conduct of Toxicology Studies , 1995, Toxicologic pathology.
[20] J. Swenberg. Bioassay design and MTD setting: old methods and new approaches. , 1995, Regulatory toxicology and pharmacology : RTP.
[21] G. Hajian,et al. Nonclinical Toxicology Studies with Zidovudine: Acute, Subacute, and Chronic Toxicity in Rodents, Dogs, and Monkeys , 1996 .
[22] G. Scott. Interferon: pharmacokinetics and toxicity. , 1982, Philosophical transactions of the Royal Society of London. Series B, Biological sciences.
[23] B. Ames,et al. Too many rodent carcinogens: mitogenesis increases mutagenesis. , 1990, Science.
[24] G. Zbinden. Safety Evaluation of Biotechnology Products , 1990, Drug safety.
[25] Joy A. Cavagnaro,et al. Preclinical safety evaluation of biotechnology-derived pharmaceuticals , 2002, Nature Reviews Drug Discovery.
[26] Nonclinical Toxicology Studies with Zidovudine: Genetic Toxicity Tests and Carcinogenicity Bioassays in Mice and Rats , 1996 .
[27] T. Priestman,et al. Monkeys are insensitive to pyrogenic effects of human α-interferons , 1982, Nature.
[28] J. Contrera,et al. Carcinogenicity testing and the evaluation of regulatory requirements for pharmaceuticals. , 1997, Regulatory toxicology and pharmacology : RTP.
[29] Bradley L Ackermann,et al. Recent advances in use of LC/MS/MS for quantitative high-throughput bioanalytical support of drug discovery. , 2002, Current topics in medicinal chemistry.
[30] C. E. Lumley. General pharmacology, the international regulatory environment, and harmonization of guidelines , 1994 .
[31] R. Tamura,et al. Comparison of the immunogenicity of recombinant and pituitary human growth hormone in rhesus monkeys. , 1991, Fundamental and applied toxicology : official journal of the Society of Toxicology.
[32] M. Golub,et al. Immunological aspects of toxicology: premises not promises. , 1989, Regulatory toxicology and pharmacology : RTP.
[33] F. Staedtler,et al. Toxicogenomics in Drug Development , 2003, Toxicologic pathology.
[34] G. Descotes,et al. Drug immunotoxicological approaches with some selected medical products: cyclophosphamide, methylprednisolone, betamethasone, cefoxitine, minor tranquillizers. , 1982, Toxicology letters.
[35] Report of validation study of assessment of direct immunotoxicity in the rat. The ICICIS Group Investigators. International Collaborative Immunotoxicity Study. , 1998, Toxicology.
[36] E. Calabrese. Paradigm lost, paradigm found: the re-emergence of hormesis as a fundamental dose response model in the toxicological sciences. , 2005, Environmental pollution.
[37] J. Haseman. Issues in Carcinogenicity Testing: Dose Selection , 1985 .
[38] S. Walker,et al. The value of chronic animal toxicology studies of pharmaceutical compounds: A retrospective analysis. , 1985, Fundamental and applied toxicology : official journal of the Society of Toxicology.
[39] J. Dean. A Brief History of Immunotoxicology and a Review of the Pharmaceutical Guidelines , 2004, International journal of toxicology.
[40] G. B. Gori. Are animal tests relevant in cancer risk assessment? A persistent issue becomes uncomfortable. , 1991, Regulatory toxicology and pharmacology : RTP.
[41] K. Cantell,et al. Synthesis in E. coli of a polypeptide with human leukocyte interferon activity , 1980, Nature.
[42] D. Amacher,et al. A toxicologist's guide to biomarkers of hepatic response , 2002, Human & experimental toxicology.
[43] D. Hunninghake,et al. Biotransformation of lovastatin. V. Species differences in in vivo metabolite profiles of mouse, rat, dog, and human. , 1993, Drug metabolism and disposition: the biological fate of chemicals.
[44] E. Rinderknecht,et al. Antiviral effects of bacteria-derived human leukocyte interferons against encephalomyocarditis virus infection of squirrel monkeys , 2005, Archives of Virology.
[45] T. Baillie,et al. Drug metabolites in safety testing. , 2002, Toxicology and applied pharmacology.
[46] B. Wallmark. Mechanism of action of omeprazole. , 1986, Scandinavian journal of gastroenterology. Supplement.
[47] L. Koller. A perspective on the progression of immunotoxicology. , 2001, Toxicology.
[48] A. Riggs,et al. Expression in Escherichia coli of chemically synthesized genes for human insulin. , 1979, Proceedings of the National Academy of Sciences of the United States of America.
[49] H. Larsson,et al. Pharmacology and toxicology of omeprazole--with special reference to the effects on the gastric mucosa. , 1986, Scandinavian journal of gastroenterology. Supplement.
[50] R Scott Obach,et al. SEEING THROUGH THE MIST: ABUNDANCE VERSUS PERCENTAGE. COMMENTARY ON METABOLITES IN SAFETY TESTING , 2005, Drug Metabolism and Disposition.
[51] K. Luthman,et al. Caco-2 monolayers in experimental and theoretical predictions of drug transport , 1996 .
[52] M. Gralinski. The assessment of potential for QT interval prolongation with new pharmaceuticals: impact on drug development. , 2000, Journal of pharmacological and toxicological methods.
[53] Jeffery A Engelhardt,et al. The no-observed-adverse-effect-level in drug safety evaluations: use, issues, and definition(s). , 2005, Regulatory toxicology and pharmacology : RTP.
[54] J. Weissinger. Pharmacology and Toxicology of Novel Drug Delivery Systems , 1990 .
[55] P. Baldrick. Pharmaceutical excipient development: the need for preclinical guidance. , 2000, Regulatory toxicology and pharmacology : RTP.
[56] Munro Ic. Considerations in chronic toxicity testing: the chemical, the dose, the design. , 1977 .
[57] Melvin E Andersen,et al. Toxicokinetics and Physiologically Based Toxicokinetics in Toxicology and Risk Assessment , 2003, Journal of toxicology and environmental health. Part B, Critical reviews.
[58] D. Davis,et al. “Hormesis”—An Inappropriate Extrapolation from the Specific to the Universal , 2004, International journal of occupational and environmental health.
[59] L. Lemberger. Early clinical evaluation in man: the buck stops here. , 1987, Xenobiotica; the fate of foreign compounds in biological systems.
[60] Ian Ragan,et al. Preclinical development of monoclonal antibodies , 2009, mAbs.
[61] D. Gaylor,et al. New directions for predicting carcinogenesis , 1997, Molecular carcinogenesis.
[62] A B Wilson. The toxicology of the end products from biotechnology processes. , 1987, Archives of toxicology. Supplement. = Archiv fur Toxikologie. Supplement.
[63] G. Zbinden. Invited contribution: Acute toxicity testing, public responsibility and scientific challenges , 1986, Cell Biology and Toxicology.
[64] R. Tennant,et al. Evaluation of transgenic mouse bioassays for identifying carcinogens and noncarcinogens. , 1996, Mutation research.
[65] R. W. Hansen,et al. The price of innovation: new estimates of drug development costs. , 2003, Journal of health economics.
[66] N. Friedmann. Thymopentin: Safety overview , 1985, Survey of immunologic research.
[67] J. Caldwell,et al. The current status of attempts to predict species differences in drug metabolism. , 1981, Drug metabolism reviews.
[68] C. Bowman,et al. Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices. , 2011, Birth defects research. Part B, Developmental and reproductive toxicology.
[69] M. Klegerman,et al. Lymphokines and Monokines , 1993 .
[70] J. Martial,et al. Human growth hormone: complementary DNA cloning and expression in bacteria. , 1979, Science.
[71] W. Hoffman,et al. Analysis of rodent growth data in toxicology studies. , 2002, Toxicological sciences : an official journal of the Society of Toxicology.
[72] Rick Mullin. Drug Development Costs About $1.7 Billion , 2003 .
[73] K. Cassidy,et al. Characterization of 2-[[4-[[2-(1H-tetrazol-5-ylmethyl)phenyl]methoxy]methyl]quinoline N-glucuronidation by in vitro and in vivo approaches. , 2001, Drug metabolism and disposition: the biological fate of chemicals.
[74] Iftekhar Mahmood,et al. Interspecies scaling of biliary excreted drugs: a comparison of several methods. , 2005, Journal of pharmaceutical sciences.
[75] C. E. Lumley,et al. A Toxicology Databank Based on Animal Safety Evaluation Studies of Pharmaceutical Compounds , 1985, Human toxicology.
[76] L Ekman,et al. Toxicological studies on omeprazole. , 1985, Scandinavian journal of gastroenterology. Supplement.
[77] P. Yi,et al. A radiocalibration method with pseudo internal standard to estimate circulating metabolite concentrations. , 2010, Bioanalysis.
[78] Chang-Ho Ahn,et al. Regulatory considerations for preclinical development of anticancer drugs , 1997, Cancer Chemotherapy and Pharmacology.
[79] J. Litchfield. Forecasting drug effects in man from studies in laboratory animals. , 1961, JAMA.
[80] J. Fenters,et al. Development of a testing battery to assess chemical-induced immunotoxicity: National toxicology program's guidelines for immunotoxicity evaluation in mice , 1988 .
[81] P. Trotta. Preclinical biology of alpha interferons. , 1986, Seminars in oncology.
[82] J. Zapp. Extrapolation of animal studies to the human situation. , 1977, Journal of toxicology and environmental health.
[83] C. Swift,et al. Stereoselectivity of ibuprofen metabolism and pharmacokinetics following the administration of the racemate to healthy volunteers , 2002, Xenobiotica; the fate of foreign compounds in biological systems.
[84] P. de Miranda,et al. Nonclinical toxicology studies with zidovudine: reproductive toxicity studies in rats and rabbits. , 1996, Fundamental and applied toxicology : official journal of the Society of Toxicology.
[85] M. Fielden,et al. The role of early in vivo toxicity testing in drug discovery toxicology , 2008 .
[86] F. Sundler,et al. Plasma gastrin and gastric enterochromaffinlike cell activation and proliferation. Studies with omeprazole and ranitidine in intact and antrectomized rats. , 1986, Gastroenterology.
[87] G. Zbinden,et al. Toxicity of interferon and interleukin , 1987 .
[88] J. Kramer,et al. The application of discovery toxicology and pathology towards the design of safer pharmaceutical lead candidates , 2007, Nature Reviews Drug Discovery.
[89] Kiyomi Ito,et al. Prediction of Human Drug Clearance from in Vitro and Preclinical Data Using Physiologically Based and Empirical Approaches , 2004, Pharmaceutical Research.
[90] G. Zbinden. The significance of pharmacologic screening tests in the preclinical safety evaluation of new drugs. , 1966, The Journal of New Drugs.
[91] Edward J Calabrese,et al. Toxicology rethinks its central belief , 2003, Nature.
[92] Italo Poggesi,et al. Predicting human pharmacokinetics from preclinical data. , 2004, Current opinion in drug discovery & development.
[93] Shibing Deng,et al. A Simple Liquid Chromatography-Tandem Mass Spectrometry Method to Determine Relative Plasma Exposures of Drug Metabolites across Species for Metabolite Safety Assessments , 2010, Drug Metabolism and Disposition.
[94] K. Norbury. Immunotoxicology in the pharmaceutical industry. , 1982, Environmental health perspectives.
[95] Salomon Sand,et al. The Benchmark Dose Method—Review of Available Models, and Recommendations for Application in Health Risk Assessment , 2003, Critical reviews in toxicology.
[96] L. Lasagna,et al. From DNA to NDA--the impact of recombinant DNA technology on new drug development. , 1985, Regulatory toxicology and pharmacology : RTP.
[97] G. Boorman,et al. Methods and approaches for assessing immunotoxicity: an overview. , 1982, Environmental health perspectives.
[98] R. Dunn,et al. Concise review: gene expression applied to toxicology. , 1999, Toxicological sciences : an official journal of the Society of Toxicology.
[99] F. Kishida,et al. Simulation of the toxicokinetics of trichloroethylene, methylene chloride, styrene and n-hexane by a toxicokinetics/toxicodynamics model using experimental data. , 2005, Environmental sciences : an international journal of environmental physiology and toxicology.
[100] Scott Gm. The toxic effects of interferon in man. , 1983 .
[101] J Higginson. Multiplicity of factors involved in cancer patterns and trends. , 1980, Journal of environmental pathology and toxicology.
[102] G. Zbinden. Current trends in safety testing and toxicological research , 1982, Die Naturwissenschaften.
[103] E J Calabrese,et al. Improved method for selection of the NOAEL. , 1994, Regulatory toxicology and pharmacology : RTP.
[104] S. Walker,et al. An International Appraisal of the Minimum Duration of Chronic Animal Toxicity Studies , 1992, Human & experimental toxicology.
[105] W M Kluwe. The complementary roles of in vitro and in vivo tests in genetic toxicology assessment. , 1995, Regulatory toxicology and pharmacology : RTP.
[106] G. Boorman,et al. Procedures available to examine the immunotoxicity of chemicals and drugs. , 1982, Pharmacological reviews.
[107] R. Ings,et al. New Approaches to the Use of Pharmacokinetics in Toxicology and Drug Development , 1988, Human toxicology.
[108] B. Lima,et al. Mechanisms of nongenotoxic carcinogenesis and assessment of the human hazard. , 2000 .
[109] S. Ankier,et al. Research and Development of New Medicines , 1989, The Journal of international medical research.
[110] J Ashby,et al. Alternatives to the 2-species bioassay for the identification of potential human carcinogens , 1996, Human & experimental toxicology.
[111] A. Fletcher,et al. Drug Safety Tests and Subsequent Clinical Experience , 1978, Journal of the Royal Society of Medicine.
[112] J. Weissinger. Nonclinical pharmacologic and toxicologic considerations for evaluating biologic products. , 1989, Regulatory toxicology and pharmacology : RTP.
[113] H. Schellekens,et al. The Chimpanzee as a Model to Test the Side Effects of Human Interferons , 1984, Journal of medical primatology.
[114] I. Horii. Dose selection for carcinogenicity studies of pharmaceuticals. , 1995, The Journal of toxicological sciences.
[115] L. Lasagna. PREDICTING HUMAN DRUG SAFETY FROM ANIMAL STUDIES : CURRENT ISSUES , 1987 .
[116] G. Zbinden. The problem of the toxicologic examination of drugs in animals and their safety in man , 1964, Clinical pharmacology and therapeutics.
[117] Anthony Clemento. New and Integrated Approaches to Successful Accelerated Drug Development , 1999 .
[118] G. Zbinden. Effects of recombinant human alpha-interferon in a rodent cardiotoxicity model. , 1990, Toxicology letters.
[119] R. Pohland,et al. Comparison of quantitative whole-body autoradiographic and tissue dissection techniques in the evaluation of the tissue distribution of [14C]daptomycin in rats. , 1994, Journal of pharmaceutical sciences.
[120] V. Bocci. Physicochemical and biologic properties of interferons and their potential uses in drug delivery systems. , 1992, Critical reviews in therapeutic drug carrier systems.
[121] D. Jenssen,et al. Studies of Metabolism Mediated Mutagenicity In Vitro , 1990 .
[122] R. Frothingham,et al. Rates of Torsades de Pointes Associated with Ciprofloxacin, Ofloxacin, Levofloxacin, Gatifloxacin, and Moxifloxacin , 2001, Pharmacotherapy.
[123] Luis G Valerio,et al. In silico toxicology for the pharmaceutical sciences. , 2009, Toxicology and applied pharmacology.
[124] Keith W Ward,et al. A comprehensive analysis of the role of correction factors in the allometric predictivity of clearance from rat, dog, and monkey to humans. , 2004, Journal of pharmaceutical sciences.
[125] K. Hastings. Implications of the new FDA/CDER immunotoxicology guidance for drugs. , 2002, International immunopharmacology.
[126] P. Morrow,et al. Dust overloading of the lungs: update and appraisal. , 1992, Toxicology and applied pharmacology.
[127] L. Lasagna. Clinical testing of products prepared by biotechnology. , 1986, Regulatory toxicology and pharmacology : RTP.
[128] W. Creutzfeldt,et al. Session 6: Is Hypergastrinaemia Dangerous to Man? , 1991 .
[129] Use of the Ames test in toxicology. , 1985, Regulatory toxicology and pharmacology : RTP.
[130] A. Howell,et al. A phase I toxicity study of human rDNA interferon in patients with solid tumours , 2004, Cancer Chemotherapy and Pharmacology.
[131] A. Monro,et al. What is an appropriate measure of exposure when testing drugs for carcinogenicity in rodents? , 1992, Toxicology and applied pharmacology.
[132] J. DiMasi. Risks, regulation, and rewards in new drug development in the United States. , 1994, Regulatory toxicology and pharmacology : RTP.
[133] J. Bucher,et al. Evaluating the human relevance of chemically induced animal tumors. , 2004, Toxicological sciences : an official journal of the Society of Toxicology.
[134] J. Vos,et al. Histopathologic Approaches to Detect Changes Indicative of Immunotoxicity , 2000, Toxicologic pathology.
[135] L. Ellwein,et al. Cell proliferation in carcinogenesis. , 1990, Science.
[136] J. P. Van Oosterhout,et al. The utility of two rodent species in carcinogenic risk assessment of pharmaceuticals in Europe. , 1997, Regulatory toxicology and pharmacology : RTP.
[137] R. Tennant,et al. Transgenic animals in toxicology. , 1994, Fundamental and applied toxicology : official journal of the Society of Toxicology.
[138] L Lasagna,et al. Cost of innovation in the pharmaceutical industry. , 1991, Journal of health economics.
[139] J. G. Vos,et al. Immune suppression as related to toxicology. , 1977, CRC critical reviews in toxicology.
[140] Robert I. Chien. Issues in pharmaceutical economics , 1979 .
[141] P. Fu,et al. Neonatal mouse assay for tumorigenicity: alternative to the chronic rodent bioassay. , 1997, Regulatory toxicology and pharmacology : RTP.
[142] W. Choy. Principles of genetic toxicology. , 1996, Drug and chemical toxicology.
[143] P. Trown,et al. The preclinical development of roferon®‐A , 1986, Cancer.
[144] R. Bass,et al. Toxicological evaluation of biotechnology products: a regulatory viewpoint. , 1987 .
[145] J. Cavagnaro. The Principles of ICH S6 and the Case‐by‐Case Approach , 2010 .
[146] Gary M Williams,et al. Cellular systems for toxicity testing. , 1983, Annals of the New York Academy of Sciences.