Preclinical Development of Nononcogenic Drugs (Small and Large Molecules)

Comprehensive observational assessment: Ia. A systematic, quantitative procedure for assessing the behavioral and physiologic state of the mouse

Irwin, S. (1968) · Psychopharmacology · doi:10.1007/bf00401402 · Cited by 1,240

Drug Metabolites in Safety Testing

Baillie, T. A. (2002) · Toxicology and Applied Pharmacology · doi:10.1006/taap.2002.9440 · Cited by 371

Preclinical safety evaluation of biotechnology-derived pharmaceuticals

Cavagnaro, J. A. (2002) · Nature Reviews Drug Discovery · doi:10.1038/nrd822 · Cited by 340

Species differences in the structure and function of the immune system

Haley, P. J. (2003) · Toxicology · doi:10.1016/s0300-483x(03)00043-x · Cited by 336

Properties of Acyl Glucuronides: Implications for Studies of the Pharmacokinetics and Metabolism of Acidic Drugs

Faed, E. M. (1984) · Drug Metabolism Reviews · doi:10.3109/03602538409033562 · Cited by 299

GMP Audit Template, EU Guidelines (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4 en.htm)

(2009) · CRC Press eBooks · doi:10.3109/9781420081275-20 · Cited by 163

Growth hormone and insulin-like growth factor-I stimulate hormonal function and proliferation of thymic epithelial cells

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Dissolution Testing of Semisolid Dosage Forms

(2009) · CRC Press eBooks · doi:10.3109/9781420081275-21 · Cited by 128

Preclinical safety testing of monoclonal antibodies: the significance of species relevance

Chapman, K., Pullen, N., Graham, M., & Ragan, I. (2007) · Nature Reviews Drug Discovery · doi:10.1038/nrd2242 · Cited by 121

A Performance Standard for Clinical and Functional Observational Battery Examinations of Rats

Mattsson, J. L., Spencer, P. J., & Albee, R. R. (1996) · Journal of the American College of Toxicology · doi:10.3109/10915819609008716 · Cited by 117

Emerging issues in probiotic safety: 2023 perspectives

Merenstein, D., Pot, B., Leyer, G., Ouwehand, A. C., Preidis, G. A., Elkins, C. A., Hill, C., Lewis, Z. T., Shane, A. L., Zmora, N., et al. (2023) · Gut Microbes · doi:10.1080/19490976.2023.2185034 · Cited by 481

Preclinical Formulations: Insight, Strategies, and Practical Considerations

Shah, S. M., Jain, A. S., Kaushik, R., Nagarsenker, M. S., & Nerurkar, M. J. (2014) · AAPS PharmSciTech · doi:10.1208/s12249-014-0156-1 · Cited by 80

Advances of cassava starch-based composites in novel and conventional drug delivery systems: a state-of-the-art review

Das, S., Das, M. K., Jamatia, T., Bhattacharya, B., Mazumder, R., Yadav, P. K., Bishwas, N. R. G., Deka, T., Roy, D., Sinha, B., et al. (2024) · RSC Pharmaceutics · doi:10.1039/d3pm00008g · Cited by 38

Psidium guajava L.: From byproduct and use in traditional Mexican medicine to antimicrobial agent

Gutierrez-Montiel, D., Guerrero-Barrera, A. L., Vela, N. A. C., Avelar-González, F. J., & García, I. (2023) · Frontiers in Nutrition · doi:10.3389/fnut.2023.1108306 · Cited by 34

Antidiabetic profiling, cytotoxicity and acute toxicity evaluation of aerial parts of Phragmites karka (Retz.)

Mazumder, K., Sumi, T. S., Golder, M., Biswas, B., Maknoon, & Kerr, P. G. (2021) · Journal of Ethnopharmacology · doi:10.1016/j.jep.2021.113781 · Cited by 26

Clove (Syzygium aromaticum) and eugenol toxicity

Özbek, Z. A., & Ergönül, P. G. (2022) · Elsevier eBooks · doi:10.1016/b978-0-323-85177-0.00029-x · Cited by 16

Japan-Specific Key Regulatory Aspects for Development of New Biopharmaceutical Drug Products

Desai, K. G. H., Obayashi, H., Colandene, J. D., & Nesta, D. P. (2018) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2018.03.017 · Cited by 14

Toxicological Evaluation of Novel Cyclohexenone Derivative in an Animal Model through Histopathological and Biochemical Techniques

Kamil, M. R., Fatima, A., Ullah, S., Ali, G., Khan, R., Ismail, N., Qayum, M., Irimie, M., Dinu, C. G., Ahmedah, H. T., et al. (2021) · Toxics · doi:10.3390/toxics9060119 · Cited by 13

In Silico Screening of Active Compounds in Garri for the Inhibition of Key Enzymes Linked to Diabetes Mellitus

Enyoh, C. E., Maduka, T. O., Wang, Q., & Islam, M. R. (2022) · ACS Food Science & Technology · doi:10.1021/acsfoodscitech.2c00217 · Cited by 13

Good Laboratory Practice (GLP) Requirements for Preclinical Animal Studies

Srinivasan, K., Tikoo, K., & Jena, G. (2021) · Springer eBooks · doi:10.1007/978-981-16-0987-9_27 · Cited by 8

Dermatological Delivery of Nanodrugs

Shivalkar, S., Verma, A., Singh, V. K., & Sahoo, A. K. (2021) · doi:10.1002/9781119769897.ch12 · Cited by 6

Regulatory toxicology testing for pharmaceuticals

Kuppasani, P. R., & Thomas, A. (2024) · Elsevier eBooks · doi:10.1016/b978-0-443-23841-3.00021-2 · Cited by 4

Nutritional composition, phytochemicals and acute toxicity of herbal mixture (lemon, apple cider, garlic, ginger and honey) in zebrafish embryo and Wistar rat

Sajak, A. A. B., Azlan, A., Abas, F., & Hamzah, H. B. (2020) · Food Research · doi:10.26656/fr.2017.4(s1).s11 · Cited by 4

Examining the Toxicological Landscape of New Molecular Entities and Biotherapeutics

Narayanan, P. (2025) · Springer eBooks · doi:10.1007/978-3-031-81787-8_10 · Cited by 3

Regulatory issues in biological products

Sangeetha, V. P., Remya, N. S., & Mohanan, P. V. (2022) · Elsevier eBooks · doi:10.1016/b978-0-12-823966-7.00005-0 · Cited by 3

A potent candidate against Zika virus infection: Synthesis, bioactivity, radiolabeling and biodistribution studies

Kumar, S., Sharma, N., Dantas, W. M., do Nascimento, J. C. F., Maus, H., de Oliveira, R. N., Pandit, U. P., Singh, A. P., Schirmeister, T., Hazari, P. P., et al. (2022) · New Journal of Chemistry · doi:10.1039/d2nj02482a · Cited by 3

Understanding pharmacotoxicology

Pawar, B., Gupta, T., Vasdev, N., Tekade, M., Arafat, B. T., & Tekade, R. K. (2023) · Elsevier eBooks · doi:10.1016/b978-0-443-15840-7.00025-7 · Cited by 3

Toxicity Assessment of Ethanol Extract of Lygodium microphyllum

Kuncoro, H., Tappi, A. S. A. M., & Anggreini, P. (2024) · Tropical Journal of Natural Product Research · doi:10.26538/tjnpr/v8i7.20 · Cited by 3

Phytochemical characterization and evaluation of anti-amnesic activity of two source plants of Shankhapushpi

Sulaiman, C. T., Jyothi, C. K., Jinu Krishnan Unnithan, G., Prabhukumar, K. M., & Balachandran, I. (2024) · Brain Behavior and Immunity Integrative · doi:10.1016/j.bbii.2024.100085 · Cited by 3

In Vitro and In Silico Analysis of Alpha-Amylase Inhibitory Activity of Ethanolic Extract of Adhatoda vasica LeavesPreprint

Yadav, C. K., Sandhya, K. C., Thapa, S., Kandel, K., Shrestha, L., Palikhey, A., & Lamsal, A. (2023) · Preprints.org · doi:10.20944/preprints202307.1457.v1 · Cited by 3

In Vitro and in Silico Analysis of α -Amylase Inhibitory Activity of Ethanolic Extract of Adhatoda vasica Leaves

Yadav, C. K., Sandhya, K. C., & Thapa, S. (2024) · Global Advances in Integrative Medicine and Health · doi:10.1177/27536130241270621 · Cited by 2

Human Toxicity of Nanoinsecticides

Farhat, S. K., Binduja, S., & Krishnan, J. (2024) · Nanotechnology in the life sciences · doi:10.1007/978-3-031-75798-3_9 · Cited by 2

Drug discovery: Chaos can be your friend or your enemy

Miller, S. M., Moos, W. H., Munk, B. H., Munk, S. A., Hart, C. P., & Spellmeyer, D. C. (2023) · Elsevier eBooks · doi:10.1016/b978-0-12-824304-6.00012-2 · Cited by 3

Neurotropic activity and safety of methylene-cycloalkylacetate (MCA) derivative 3-(3-allyl-2-methylenecyclohexyl) propanoic acid

Lahiani, A., Haham, D., Lankri, D., Cornell-Kennon, S., Schaefer, E., Tsvelikhovsky, D., & Lazarovici, P. (2020) · ACS Chemical Neuroscience · doi:10.1021/acschemneuro.0c00255 · Cited by 2

Acute toxicity of C60–Cis-Pt nanocomplex in vivo

Lynchak, O. V., Byelinska, I. V., Dziubenko, N., Kuznietsova, H. M., Abramchuk, O., & Prylutska, S. (2021) · Applied Nanoscience · doi:10.1007/s13204-021-01680-3 · Cited by 2

Acute and 28-day toxicity evaluation of hydroethanolic extract of Eragrostis tremula (Poaceae) in Wistar rats

Nazifi, A. B., Abubakar, A., Magaji, M. G., Aliyu, M., Yaro, A. H., & DANJUMA, N. M. (2023) · Journal of Pharmacy & Bioresources · doi:10.4314/jpb.v20i3.6 · Cited by 2

Evaluation of acute oral toxicity of the Camellia sinensis phytosome formulation in female wistar rats

Mane, V. B., Killedar, S. G., & More, H. N. (2022) · International Journal of Health Sciences · doi:10.53730/ijhs.v6ns8.11579 · Cited by 1

PENGARUH PEMBERIAN DOSIS TINGGI POTASSIUM IODIDE (KI) TERHADAP FUNGSI TIROID, THYROID PEROXIDASE ANTIBODY (TPOAb), DAN BERAT BADAN PADA TIKUS JANTAN GALUR WISTAR HIPOTIROID

Hidayat, T., Samsudin, M., & Musoddaq, M. A. (2022) · Media Gizi Mikro Indonesia · doi:10.22435/mgmi.v14i1.6022 · Cited by 1

Toxicity Profiling and Antihyperuricemic Activity of Goubion: A Polyherbal Formulation

Sadia, H., Naveed, S., Rehman, H., Usman, R., Qamar, F., Yasmeen, S., Sana, A., Mughal, M., Asif, S., & Razzaq, G. (2023) · Evidence-based Complementary and Alternative Medicine · doi:10.1155/2023/7088628 · Cited by 1

Evaluation of the acute basic biological effects of herbal formulation to control obesity: a preliminary study

Kumar, M., Kaushik, D., Kaushik, R., Khan, A. U., Billeci, L., Öz, E., Proestos, C., Brennan, C. S., Ahmad, N., Elobeid, T., et al. (2023) · International Journal of Food Science & Technology · doi:10.1111/ijfs.16669 · Cited by 1

Isolation, In-silico Studies, and Biological Evaluation of Higenamine from Annona squamosa L. against Breast Cancer

Shailaja, A. D., & Pramodkumar, J. S. (2023) · International Journal of Pharmaceutical Quality Assurance · doi:10.25258/ijpqa.14.4.34 · Cited by 1

Role of Metabolism in Drug Toxicity

Coleman, M. D. (2020) · Wiley eBooks · doi:10.1002/9781119658016.ch8 · Cited by 1

Drugs From Threatened Medicinal Plants

Das, K., & Rajasekharan, P. E. (2020) · Springer eBooks · doi:10.1007/978-3-030-39793-7_12

Comments on "In Vivo Toxicological and Microbiological Activity of Marrubium vulgare L. on Candida albicans Isolated from Nosocomial Infections"

Askari, P., & Hosseini, M. (2020) · Pharmaceutical Sciences · doi:10.34172/ps.2020.87

Preclinical Efficacy Studies of a Novel Combination Cream (GN-037-C) and Lotion (GN-037-L) on Imiquimod-Induced Psoriasis of BALB/C MicePreprint

Karasulu, H. Y., Al, A. M., Diril, M., Kunt, Ş. T., Kozlu, S., & Topcu, E. (2023) · SSRN Electronic Journal · doi:10.2139/ssrn.4597971

An Acute Toxicological Assessment of Reissantia Indica Plant Extract in Male Sprague-Dawley Rats: Hematological and Serum BiochemicalPreprint

Amoateng, E. O., Amoateng, P., Ossei, P. P. S., Fenteng, E. A., Amponsah, I. K., Ayibor, W. G., Adjei, S., & Narh-Bedu, T. (2023) · SSRN Electronic Journal · doi:10.2139/ssrn.4628100

In vivo and in vitro evaluation of antidiarrhoeal properties of ethanol leaf and stem bark extract of Vitellaria paradoxa

Salawu, O. A., Micah, P. W., Ibrahim, H., Mohammed, A. S., Isaac, R. E., & Oladepo, O. M. (2025) · Oriental Pharmacy and Experimental Medicine · doi:10.1007/s13596-025-00847-5

Immunotoxicity assessment of biotechnology products: a regulatory point of view

Cavagnaro, J. A. (1995) · Toxicology · doi:10.1016/0300-483x(95)03121-u · Cited by 9

The basics of preclinical drug development for neurodegenerative disease indications

Steinmetz, K. L., & Spack, E. G. (2009) · BMC Neurology · doi:10.1186/1471-2377-9-s1-s2 · Cited by 165

Toxicology Application in Drug Development

Fan, A. M., Alexeeff, G., & Khan, E. (2015) · doi:10.1201/b18228-22

Nonclinical Safety Evaluation of Drugs

Monticello, T. M., & Bussiere, J. L. (2018) · CRC Press eBooks · doi:10.1201/9780429504624-2

Preclinical Safety Assessment: General and Genetic Toxicology

LeRoy, B. E., & Blomme, E. A. G. (2025) · Elsevier eBooks · doi:10.1016/b978-0-443-11881-4.00003-x · Cited by 1