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Toxicology Course & Certification
Intermediate
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3 hours
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About
Toxicology training provides an overview of the principles and practices used to evaluate the nonclinical safety of investigational drugs before and during clinical development. It helps learners understand how toxicology studies identify potential hazards, characterize target-organ toxicity, establish safe exposure levels, and support decisions about first-in-human clinical trials.
This Toxicology Course & Certification provides essential knowledge on acute and repeat-dose toxicity, NOAEL, LOAEL, MTD, exposure and safety margins, human equivalent dose calculations, safety factors, MABEL, safety pharmacology, genotoxicity, reproductive and developmental toxicity, and carcinogenicity. The course also covers GLP principles, regulatory expectations, Investigator's Brochure and CTD documentation, and how nonclinical findings are translated into clinical monitoring, eligibility criteria, stopping rules, and trial duration. Upon successful completion, learners receive a certification demonstrating their understanding of toxicology principles and the application of nonclinical safety data in drug development.
Who Should Enrol?
- Clinical Research Associates (CRAs) and Clinical Research Professionals
- Pharmacovigilance and Drug Safety Professionals
- Regulatory Affairs and Clinical Regulatory Professionals
- Toxicology and Nonclinical Safety Professionals
- Clinical Development and Medical Affairs Teams
- Quality Assurance and Compliance Professionals
- Pharmacologists and Drug Development Scientists
- Anyone involved in evaluating, interpreting, or applying nonclinical safety data in drug development
What you will learn
Understand the fundamental principles of toxicology and the role of nonclinical safety studies in drug development, including acute, repeat-dose, and target-organ toxicity assessment.
Learn how to interpret key toxicology concepts such as NOAEL, LOAEL, MTD, exposure margins, human equivalent dose, safety factors, and MABEL, and understand their relevance to first-in-human dose selection.
Develop knowledge of safety pharmacology, genotoxicity, reproductive and developmental toxicity, carcinogenicity, and common target-organ findings including hepatic, cardiac, and bone marrow toxicity.
Gain understanding of GLP, regulatory expectations, nonclinical documentation, Investigator's Brochure and CTD requirements, and how toxicology findings inform clinical trial duration, monitoring, stopping rules, and safety assessments.
Course Syllabus
- Why harm must be characterised before the first human dose
- Dose-response and 'the dose makes the poison'
- Dose-limiting toxicity and the maximum tolerated dose
- NOAEL and LOAEL - reading them off a dose-response
- Safety and exposure margins - why a bigger margin is more comfortable
- Reversibility, adverse vs adaptive change, GLP and toxicokinetics
- Worked example - reading a veltarib dose-response table
- Acute (single-dose) toxicity - initial hazard
- Repeat-dose, subchronic and chronic toxicity - target organs and NOAEL
- Safety pharmacology (cardiovascular incl. hERG/QT, respiratory, CNS)
- Genotoxicity - Ames, in-vitro mammalian and in-vivo micronucleus
- Carcinogenicity and reproductive/developmental toxicity (DART)
- How study duration and timing gate each clinical phase (ICH M3(R2))
- Worked example - matching veltarib findings to the study type
- NOAEL to human equivalent dose (HED) via allometric scaling
- Choosing the species that gives the lowest, most conservative HED
- The safety factor (default 10) and when to increase it
- The maximum recommended starting dose (MRSD); MABEL and the PAD check
- How the first-in-human protocol uses the starting dose, escalation and stopping rules
- How tox findings become clinical monitoring (liver, cardiac, blood, renal)
- Worked example - veltarib NOAEL to HED to MRSD, step by step
- Describing findings by target organ
- Hepatotoxicity - ALT, AST, ALP and bilirubin as readouts
- Hy's Law conceptually and why veltarib's finding does not meet it
- Cardiotoxicity - the hERG channel, QT prolongation and torsade risk
- The hERG-to-QT screening logic and veltarib's comfortable margin
- Other target organs - kidney, bone marrow/blood, GI, CNS, immune
- Worked example - reading an LFT panel against Hy's Law
- Where the nonclinical safety story lives (IB, IND/IMPD, CTD Module 2.4/2.6)
- The structure of a nonclinical safety summary
- Reading a NOAEL, target-organ and margin line by line
- What a CRA, QA, regulatory or PV reviewer looks for
- How tox findings connect to the protocol's monitoring and eligibility
- Common misreadings to avoid
- Worked example - reading a mock veltarib IB nonclinical safety table
- Cross-reference General Pharmacology - ADME/PK and how exposure and margins arise
- Cross-reference Clinical Phases - where nonclinical tox sits before Phase I
- Which studies gate which phase (ICH M3(R2))
- How tox flows into the IND/IMPD and the first-in-human protocol
- How nonclinical safety keeps informing pharmacovigilance and benefit-risk
- The regulatory map - ICH M3, the S-series, FDA and EMA first-in-human guidance
- Worked example - tracing veltarib from NOAEL to the FIH protocol
- Synthesis - what tox establishes; the study battery; NOAEL to HED to MRSD
- Organ-specific basics - Hy's Law and hERG/QT
- Reading a toxicology summary in an Investigator's Brochure
- How it all connects to pharmacology, clinical phases and pharmacovigilance
- A one-page toxicology-literacy checklist
- Glossary and references pointer; boundary note
- 📘 Bonus: Toxicology eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development points on completion of this course.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (estimands and sensitivity analysis), ICH E3 (clinical study reports) and CONSORT 2010 reporting standards for time-to-event endpoints, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by practitioners in oncology and clinical-trial biostatistics to ensure that learners can read a Kaplan-Meier curve and a forest plot, interpret a hazard ratio, and report a survival analysis that will withstand regulatory and peer review.
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