Search Tools
- FDA Website
- Clinical trials registry
- NLM NIH PubMed
- NIH ToxTutor: a self-paced tutorial covering key principles of toxicology for users of the National Library of Medicine (NLM) chemical and toxicology databases. It is divided into the following sections:
- Introduction to Toxicology
- Dose and Dose-Response
- Toxic Effects
- Interactions
- Toxicity Testing Methods
- Risk Assessment
- Exposure Standards and Guidelines
- Basic Physiology
- Introduction to Toxicokinetics
- Absorption
- Distribution
- Biotransformation
- Excretion
- Cellular Toxicology
- Intuitive Toxicology and Risk Communication
- Environmental Toxicology, Environmental Health, and One Health
- Conclusion
Covid-19 Related Resources:
- FDA Coronavirus Treatment Acceleration Program (CTAP): special emergency program for possible COVID-19 therapeutics
Disease-Related Resources:
Cardiology
- Han et al. Pulmonary diseases and the heart. Circulation. 2007;116:2992-3005.
Gastrointestinal System:
- “Medical Physiology: The Big Picture” by Kibble and Halsey. Chapter 7, The Gastrointestinal System
Hypertension:
Neurological Disorders:
Oncology:
Reproduction
Genetic Editing
- MIT Technology Review. “First Human Embryos Edited in U.S.” by Steve Connor on Jul 26, 2017.
- Nature News. “CRISPR gene editing in human embryos wreaks chromosomal mayhem” by Heidi Ledford on June 25, 2020.
Overcoming Infertility from Chemotherapy
- Express (UK). “Artificial ovary could help women conceive after chemotherapy and cancer treatment” by Express on July 2, 2018.
- The Atantic. “A New Hope for Male Fertility After Cancer Treatment” by Rachel Mabe on Oct 13, 2017.
Uterus Transplantation
Male Birth Control
Textbooks:
Pathophysiology
- Porth CM. Essentials of Pathophysiology. 2015 (4th Ed). Wolters Kluwer: Philadelphia, PA. ISBN-13: 978-1-4511-9080-9 OSU eBook
- Klaassen, C.D., Ed.: Casarett and Doull’s Toxicology: The Basic Science of Poisons. 8th Edition, McGraw-Hill, (2013) eBook
Toxicology
- Nelson, L., & Goldfrank, L. R. (2011). Goldfrank’s toxicologic emergencies. New York: McGraw-Hill Medical. eBook
- Rosenbaum, Sara E. Basic Pharmacokinetics and Pharmacodynamics: An Integrated Textbook and Computer Simulations. Wiley, 450 p. 2011. eISBN 9781118001059 eBook
Pharmacodynamic/Pharmacokinetics:
- Kwon, Younggil. Handbook of essential pharmacokinetics, pharmacodynamics and drug metabolism for industrial scientists. New York: Kluwer. 2002. ISBN 9780306462344 eBook
- Arthur J. Atkinson, Jr., Shiew‐Mei Huang, Juan J.L. Lertora and Sanford P. Markey. 3rd Principles of Clinical Pharmacology. San Diego: Academic Press. 2012. ISBN: 978‐0‐12‐385471‐1 eBook
- Spruill, William J., Wade, William E., DiPiro, Joseph T, Blouin, Robert A., Pruemer, Jane M. Concepts in clinical pharmacokinetics (6th Edition). American Society of Health‐System Pharmacists. 2014. ISBN: 978‐1‐58528‐387‐3 eBook
- Macheras, Panos and Iliadis, Athanassios. Modeling in biopharmaceutics, pharmacokinetics, and pharmacodynamics: Homogeneous and Heterogeneous Approaches. Springer New York. 2006. ISBN‐13: 978‐0387‐28178‐ eBook
Safety Pharmacology
- Guyton and Hall textbook of Medical Physiology, 13th Edition, John E. Hall, PhD, 2016
- Principles of Safety Pharmacology (Handbook of Experimental Pharmacology), Michael K. Pugsley and Michael Curtis, Editors, 2015
- Nonclinical Assessment of Abuse Potential for New Pharmaceuticals, Carrie Markgraf, Thomas Hudzik, and David Compton, Editors, 2015
- Electrocardiography of Laboratory Animals, Jeffrey W. Richig and Meg M. Sleeper, 2013
- Textbook of Veterinary Internal Medicine, Stephen Ettinger and Edward C. Feldman, 7th Edition (earlier editions may not have the same chapters)
- Chapters on Electrocardiographic Techniques; Echocardiography; Syncope; Pathophysiology of Heart Failure; Electrocardiography and Cardiac Arrhythmias; Neurologic Examination and Neuroanatomic Diagnosis; Vestibular Disease; and Clinical Approach and Laboratory Evaluation of Renal Disease
Post-Marketing Surveillance
- Gad, Shayne C. Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance (2nd Edition). London, GBR: CRC Press, 2012. ISBN‐13: 978‐1‐4398‐4568‐ eBook
Scientific Journals
- Journal of Pharmacological & Toxicological Methods
- Regulatory Toxicology and Pharmacology
- British Journal of Pharmacology
- Journal of Cardiovascular Pharmacology
- Journal of Applied Toxicology
- Cardiovascular Toxicology
- Expert Opinion on Drug Safety
- Toxicology and Applied Pharmacology
- Fundamental and Clinical Pharmacology
Regulatory guidelines
- Anon. (2000). ICHS7A: Safety pharmacology studies for human pharmaceuticals. CPMP/ICH/539/00. London. www.emea.eu.int/pdfs/human/ich/053900en.pdf
- Anon. (2005). HHS. International Conference on Harmonisation; guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; availability. Notice. Fed Regist. 70(202):61133-4.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129122.pdf - Anon. (1997). Committee for Proprietary Medicinal Products (CPMP) Points to Consider: The assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products. CPMP/986/96. www.ganimed.biz/bibliothek/media/EMEA_CPMP_Dec1997.pdf
- Anon. (2005). Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (E14). http://www.fda.gov/cber/gdlns/iche14qtc.pdf
- Anon. (2010). Guidance for Industry Assessment of Abuse Potential of Drugs. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM198650.pdf
- Anon. (2011). ICH S6: Preclinical safety evaluation of biotechnology-derived pharmaceuticals. CPMP/ICH/302/95. (Revised version (R1) finalised June 2011.).
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf - Anon. (2009). ICH M3(R2): Guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M3_R2/Step4/M3_R2__Guideline.pdf
- Anon. (2005). ICH S5(R2): Detection of toxicity to reproduction for medicinal products and toxicity to male fertility. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S5_R2/Step4/S5_R2__Guideline.pdf
- Anon. (2006). Food and Drug Administration. Guidance for Industry: Nonclinical Safety Evaluation of Pediatric Drug Products. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079247.pdf
- Anon. (2008). Committee for Human Medicinal Products (CHMP). Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications. EMEA/CHMP/SWP/169215/2005. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003305.pdf
- Anon. (2008). OECD: Guidance document on mammalian reproductive toxicity testing and assessment. ENV/JM/MONO(2008)16. www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2008)16&doclanguage=en
- Anon. (2008). Food and Drug Administration. Guidance for industry. Diabetes mellitus – evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071627.pdf
- Anon. (2006). FDA Guidance for Industry, Investigators and Reviewers: Exploratory IND Studies. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078933.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=exploratory IND&utm_content=1
- Anon. (2009). Nonclinical evaluation for anticancer pharmaceuticals. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S9/Step4/S9_Step4_Guideline.pdf
- Anon. (1995). Guidance for Industry Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (1995). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074937.pdf