Part XVI. Evaluation of the safety of new drugs by means of tests in animals

Concordance of the toxicity of pharmaceuticals in humans and in animals

Olson, H., Betton, G., Robinson, D., Thomas, K., Monro, A., Kolaja, G., Lilly, P., Sanders, J., Sipes, G., Bracken, W., et al. (2000) · Regulatory Toxicology and Pharmacology · doi:10.1006/rtph.2000.1399 · Cited by 2,050 · see citing works

Limitations of Animal Studies for Predicting Toxicity in Clinical Trials

Van Norman, G. A. (2019) · JACC: Basic to Translational Science · doi:10.1016/j.jacbts.2019.10.008 · Cited by 709 · see citing works

Animal to human translation: a systematic scoping review of reported concordance rates

Leenaars, C. H. C., Kouwenaar, C., Stafleu, F. R., Bleich, A., Ritskes-Hoitinga, M., De Vries, R. B. M., & Meijboom, F. L. B. (2019) · Journal of Translational Medicine · doi:10.1186/s12967-019-1976-2 · Cited by 310 · see citing works

Systematic reviews of animal models: methodology versus epistemology

Greek, R., & Menache, A. (2013) · International Journal of Medical Sciences · doi:10.7150/ijms.5529 · Cited by 207 · see citing works

An analysis of the use of animal models in predicting human toxicology and drug safety

Bailey, J., Thew, M., & Balls, M. (2014) · Alternatives to Laboratory Animals · doi:10.1177/026119291404200306 · Cited by 182 · see citing works

Potentials and limitations of nonclinical safety assessment for predicting clinical adverse drug reactions: correlation analysis of 142 approved drugs in Japan

Tamaki, C., Nagayama, T., Hashiba, M., Fujiyoshi, M., Hizue, M., Kodaira, H., Nishida, M., Suzuki, K., Takashima, Y., Ogino, Y., et al. (2013) · The Journal of Toxicological Sciences · doi:10.2131/jts.38.581 · Cited by 79 · see citing works

The Nuremberg Code subverts human health and safety by requiring animal modeling

Greek, R., Pippus, A., & Hansen, L. A. (2012) · BMC Medical Ethics · doi:10.1186/1472-6939-13-16 · Cited by 78 · see citing works

An analysis of the use of dogs in predicting human toxicology and drug safety

Bailey, J., Thew, M., & Balls, M. (2013) · Alternatives to Laboratory Animals · doi:10.1177/026119291304100504 · Cited by 71 · see citing works

Is the use of sentient animals in basic research justifiable?

Greek, R., & Greek, J. (2010) · Philosophy Ethics and Humanities in Medicine · doi:10.1186/1747-5341-5-14 · Cited by 54 · see citing works

Recent efforts to elucidate the scientific validity of animal-based drug tests by the pharmaceutical industry, pro-testing lobby groups, and animal welfare organisations

Bailey, J., & Balls, M. (2019) · BMC Medical Ethics · doi:10.1186/s12910-019-0352-3 · Cited by 51 · see citing works

Questions regarding the predictive value of one evolved complex adaptive system for a second: Exemplified by the SOD1 mouse

Greek, R., & Hansen, L. A. (2013) · Progress in Biophysics and Molecular Biology · doi:10.1016/j.pbiomolbio.2013.06.002 · Cited by 33 · see citing works

Animal Models in an Age of Personalized Medicine

Greek, R., Menache, A., & Rice, M. J. (2011) · Personalized Medicine · doi:10.2217/pme.11.89 · Cited by 30 · see citing works

Animal Experiments—A Failed Technology

Sharpe, R. (1989) · doi:10.1007/978-1-349-20376-5_5 · Cited by 28 · see citing works

The History and Biological Basis of Occupational Exposure Limits for Chemical Agents

Paustenbach, D. J. (2001) · Patty's Industrial Hygiene · doi:10.1002/0471435139.hyg041 · Cited by 28 · see citing works

Preclinical pharmacology and toxicology study of Ad-hTERT-E1a-Apoptin, a novel dual cancer-specific oncolytic adenovirus

Qi, Y., Guo, H., Hu, N., He, D., Zhang, S., Chu, Y., Huang, Y., Li, X., Sun, L., & Jin, N. (2014) · Toxicology and Applied Pharmacology · doi:10.1016/j.taap.2014.08.008 · Cited by 27 · see citing works

Animal Models in Drug Development

Greek, R. (2013) · InTech eBooks · doi:10.5772/53893 · Cited by 22 · see citing works

Animal Models and the Development of an HIV Vaccine

Greek, R. (2012) · Journal of AIDS & Clinical Research · doi:10.4172/2155-6113.s8-001 · Cited by 17 · see citing works

Data Processing and Interpretation

Evans, G. O. (2008) · CRC Press eBooks · doi:10.1201/9781420080100-14 · Cited by 16 · see citing works

Complex systems, evolution, and animal models

Greek, R., & Shanks, N. (2011) · Studies in History and Philosophy of Science Part C Studies in History and Philosophy of Biological and Biomedical Sciences · doi:10.1016/j.shpsc.2011.07.001 · Cited by 15 · see citing works

A Complete Review of Mexican Plants with Teratogenic Effects

Chamorro, G., Mojica-Villegas, M. A., García-Martínez, Y., Pérez‐Gutiérrez, S., Madrigal‐Santillán, E., Vargas-Mendoza, N., Morales‐González, J. A., & Cristóbal-Luna, J. M. (2022) · Plants · doi:10.3390/plants11131675 · Cited by 15 · see citing works

Human Tissue in the Evaluation of Safety and Efficacy of New Medicines: A Viable Alternative to Animal Models?

Coleman, R. A. (2011) · ISRN Pharmaceutics · doi:10.5402/2011/806789 · Cited by 13 · see citing works

Quantitative Concepts in the Clinical Study of Drugs

Zubrod, C. G. (1964) · Elsevier eBooks · doi:10.1016/b978-1-4831-9929-0.50007-3 · Cited by 13 · see citing works

Drug Development and Nonclinical to Clinical Translational Databases

Monticello, T. M. (2014) · Toxicologic Pathology · doi:10.1177/0192623314557189 · Cited by 12 · see citing works

Current problems in the choice of animals for toxicity testing

Stevenson, D. E. (1979) · Journal of Toxicology and Environmental Health · doi:10.1080/15287397909529720 · Cited by 10 · see citing works

EARLY EVALUATION OF PSYCHOTROPIC DRUGS IN MAN

Blackwell, B., & Shepherd, M. (1967) · The Lancet · doi:10.1016/s0140-6736(67)92250-7 · Cited by 10 · see citing works

Stable Gastric Pentadecapeptide BPC 157 as a Therapy and Safety Key: A Special Beneficial Pleiotropic Effect Controlling and Modulating Angiogenesis and the NO-System

Sikirić, P., Seiwerth, S., Škrtić, A., Starešinić, M., Štrbe, S., Vukšić, A., Sikirić, S., Bekić, D., Soldo, D., Grizelj, B., et al. (2025) · Pharmaceuticals · doi:10.3390/ph18060928 · Cited by 9 · see citing works

Statistical analysis of preclinical inter-species concordance of histopathological findings in the eTOX database

Wright, P. S. R., Briggs, K. A., Thomas, R., Smith, G. F., Maglennon, G., Mikulskis, P., Chapman, M., Greene, N., Phillips, B. U., & Bender, A. (2023) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2022.105308 · Cited by 8 · see citing works

The Ethical Implications for Humans in Light of the Poor Predictive Value of Animal Models

Greek, R. (2014) · International Journal of Clinical Medicine · doi:10.4236/ijcm.2014.516129 · Cited by 8 · see citing works

Model Selection in Toxicology: Principles and Practice

Gad, S. C. (1990) · Journal of the American College of Toxicology · doi:10.3109/10915819009078740 · Cited by 8 · see citing works

Drug Safety Evaluation: Animal Toxicology Studies and Their Interpretations

Kesterson, J. W. (1982) · Drug Information Journal · doi:10.1177/009286158201600104 · Cited by 8 · see citing works

Communication between the experimental animal and the pharmacologist*

van Noordwijk, J. (1964) · Statistica Neerlandica · doi:10.1111/j.1467-9574.1964.tb00527.x · Cited by 8 · see citing works

Translation of nonclinical to clinical safety findings for 27 biotherapeutics

Leach, M. W., Rana, P., Hu, W., Mittapalli, R. K., Pinkstaff, J. K., Potter, D., Qiu, X. M., Ramaiah, L., Rohde, C. M., Xia, F., et al. (2024) · Toxicology and Applied Pharmacology · doi:10.1016/j.taap.2024.116854 · Cited by 7 · see citing works

New approach methodologies for risk assessment of urinary occurring toxicants

Jobst, M., Guerreiro, I., Payros, D., Oswald, I. P., Fernandes, A. S., Warth, B., & Favero, G. D. (2025) · Ecotoxicology and Environmental Safety · doi:10.1016/j.ecoenv.2025.118649 · Cited by 6 · see citing works

A novel ex vivo model for critical illness neuromyopathy using freshly resected human colon smooth muscle

Patejdl, R., Klawitter, F., Walter, U., Zanaty, K., Schwandner, F., Sellmann, T., Porath, K., & Ehler, J. (2021) · Scientific Reports · doi:10.1038/s41598-021-03711-z · Cited by 6 · see citing works

The Predictive Value of Animal Toxicity Studies Carried Out on New Drugs

Golberg, L. (1963) · The Journal of New Drugs · doi:10.1002/j.1552-4604.1963.tb00054.x · Cited by 6 · see citing works

THE USE OF LABORATORY ANIMALS FOR DRUG TESTING

Durbin, C. G., & Robens, J. F. (1964) · Annals of the New York Academy of Sciences · doi:10.1111/j.1749-6632.1964.tb53138.x · Cited by 6 · see citing works

Acute Compartment Syndrome and Intra-Abdominal Hypertension, Decompression, Current Pharmacotherapy, and Stable Gastric Pentadecapeptide BPC 157 Solution

Sikirić, P., Seiwerth, S., Škrtić, A., Starešinić, M., Štrbe, S., Vukšić, A., Sikirić, S., Bekić, D., Penovic, T., Draženović, D., et al. (2025) · Pharmaceuticals · doi:10.3390/ph18060866 · Cited by 4 · see citing works

A Discussion of the Role of Complex Evolved Systems in the Development of Invasive Cardiovascular Interventions as Illustrated by the Blalock- Taussig Shunt and Intra-Arterial Stents

Greek, R. (2014) · Biological Systems Open Access · doi:10.4172/2329-6577.1000124 · Cited by 3 · see citing works

First Clinical Trials of Potential Drugs

LAURENCE, D. R. (1964) · Elsevier eBooks · doi:10.1016/b978-1-4832-2845-7.50007-4 · Cited by 3 · see citing works

Methods and Practices of Animal Experimentation

Millstone, E. P. (1989) · doi:10.1007/978-1-349-20376-5_4 · Cited by 3 · see citing works

Techniques Used to Assess the Efficacy of Psychotropic Drugs: A Critical Review

Newmark, C. S. (1971) · Psychological Reports · doi:10.2466/pr0.1971.28.3.715 · Cited by 3 · see citing works

Animal Models of Long Term Toxic Effects

Worden, A. N., & Walker, S. (1987) · Springer eBooks · doi:10.1007/978-94-009-3201-2_4 · Cited by 3 · see citing works

Data Processing and Interpretation

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The Science of Toxicology-Scope, Goals and Four Case Studies

Matter, B. E. (1984) · Springer eBooks · doi:10.1007/978-1-4613-2399-0_27 · Cited by 2 · see citing works

Toxic Hazards from Drugs

Barnes, J. M. (1963) · Journal of Pharmacy and Pharmacology · doi:10.1111/j.2042-7158.1963.tb11191.x · Cited by 2 · see citing works

Telemetry in Nonclinical Drug Safety Assessment Studies

Gad, S. C., & Gad, S. C. (2015) · CRC Press eBooks · doi:10.1201/b18705-17 · Cited by 1 · see citing works

The human predictive value of combined animal toxicity testing: current state and emerging approaches

Olson, H. M., & Davies, T. S. (2010) · Cambridge University Press eBooks · doi:10.1017/cbo9780511779053.003 · Cited by 1 · see citing works

Arzneimittelregulierung

Krücken, G. (1997) · VS Verlag für Sozialwissenschaften eBooks · doi:10.1007/978-3-322-86884-8_4 · Cited by 1 · see citing works

Epidemiology in Food Safety Evaluation-Past and Present

Riche, W. H. L. (1976) · Clinical Toxicology · doi:10.3109/15563657608988174 · Cited by 1 · see citing works

Animal Models in Science and Research

Greek, R. (2019) · doi:10.1002/9781118907283.ch29 · Cited by 1 · see citing works

Animal Tests as Predictors of Human Response

Folb, P. I. (2005) · CRC Press eBooks · doi:10.1201/9781420039146.ch4 · Cited by 1 · see citing works

Food safety as seen by an epidemiologist.

Wh, L. E. R. (1968) · PubMed Central

Synthesis and biological activity of new thebaine derivatives

Толстиков, Г. А., Tolstikova, T. G., Shultz, E. E., Mukhametyanova, T. S., Popov, V. G., Давыдова, В. А., Лазарева, Д. Н., Зарудий, Ф. С., Spirikhin, L. V., Chertanova, L. F., et al. (1993) · Pharmaceutical Chemistry Journal · doi:10.1007/bf00767655

Ethics and Evidence Regarding Animal Subjects Research: Splitting Hares–or Swallowing Camels?

Norman, G. A. V. (2015) · Springer eBooks · doi:10.1007/978-3-319-15949-2_17

Some Limitations of Animal Tests

Rümke, L. (1964) · Elsevier eBooks · doi:10.1016/b978-1-4832-2845-7.50011-6

Animal Tests as Predictors of Human Response

Folb, P. I. (1990) · doi:10.1007/978-1-349-10705-6_5

Ethics of Using Human Cells/Tissues for 3D Tissue Models

Lim, J. Y., Kim, D. H., Park, S. H., & Kim, S. W. (2019) · Royal Society of Chemistry eBooks · doi:10.1039/9781788012683-00329

Introduction

Ph.D., H. S., M.Sc., D. I. C. A. V. S. D. R., & Julie Knight, B. A. (1964) · Novartis Foundation symposium · doi:10.1002/9780470719329.ch26

Considerations Specific to Animal Test Models

Gad, S. C., & Chengelis, C. P. (1998) · Elsevier eBooks · doi:10.1016/b978-012272250-9/50012-5

Evaluation of Safety of New Drugs By the Food and Drug Administration

Smith, R. G. (1961) · The Journal of New Drugs · doi:10.1177/009127006100100202 · Cited by 2 · see citing works

fi©ifi1ll The Role of ClinicalChemistry in Chemical and Drug Safety Evaluationby Use of Laboratory Animals

Dooley, J. (2015)

Bolstering the FDA's Drug-Safety Authority

Schultz, W. B. (2007) · New England Journal of Medicine · doi:10.1056/nejmp078212 · Cited by 36 · see citing works

Safety Assessment

Boelsterli, U. A. (2023) · CRC Press eBooks · doi:10.1201/9781003346661-18

Risk predicted from animal studies

Zbinden, G. (1987) · Springer eBooks · doi:10.1007/978-94-009-3221-0_5 · Cited by 5 · see citing works