Beginners Guide To Toxicology
Foundations of Safety: A Comprehensive Beginners Guide to Toxicology in Drug Development – Understanding Assessments, Risk Identification, and Clinical Implications
Toxicology Training Courses: Beginners Guide to Toxicology
Learn the principles of practical toxicology
About the Course
The non-clinical safety assessment for marketing approval of a pharmaceutical product usually includes pharmacology studies, general toxicity studies, toxicokinetic and non-clinical pharmacokinetic studies, reproduction toxicity studies, and genotoxicity studies. For biotechnology-derived products, appropriate non-clinical safety studies should also be conducted on a case-by-case basis. Non-clinical safety studies and human clinical trials should be planned and designed to represent an approach that is scientifically and ethically appropriate.
In toxicology, it should be possible to distinguish expected pharmacology (related to the mechanism of action of the drug) from unexpected or abnormal pharmacology. It should also be possible to rank molecules based on their intrinsic toxic potential and to identify potential adverse effects. These effects should be correlated in toxicology with exposure to assess the presence of a dose-response. Overall toxicology studies should allow the extrapolation from non-clinical data of the human situation. This will allow the inclusion of suitable assessments during clinical development to ensure that the safety of the enrolled subjects (either healthy volunteers or patients) is maintained.
Who Will Benefit
Our toxicology training courses are beneficial to everyone involved in drug development.
- Clinical research associates
- Medicinal chemists
- Pharmacologists
- Toxicologists
- Project managers
- Business development managers
- Medical writers
Key Learning Objectives
- Learn the principles of practical toxicology
- Understand the role of toxicology in the different phases of drug development
- Learn the principles of regulatory toxicology
- Main toxicology studies and related disciplines
- Understand the definition and role of “toxicokinetics”
- Toxicology terminology
- Understand description concept of ‘safety margins’
- Gain insights through practical case studies
Run this course in-house
Informa Connect Academy’s customised training solutions have helped organisations deliver tailored learning in different languages to suit every requirement.
Bespoke training designed for your organisation only, combining traditional classroom setting, blended and online learning models
Next Courses
schedule Date | maps_home_work Delivery Type | person Trainer | language Language | ||
|---|---|---|---|---|---|
21 Oct 2024 40 days Australia/Sydney | location_on Scheduled Digital Australia | Stefano Persiani | English | AUD$2,095.00 | |
21 Oct 2024 40 days Singapore | location_on Scheduled Digital Singapore | Stefano Persiani | English | SGD$2,095.00 |
21 Oct 2024
40 days, Australia/Sydney
location_onScheduled Digital
Australia
Language: English
Trainer: Stefano Persiani
AUD$2,095.00
21 Oct 2024
40 days, Singapore
location_onScheduled Digital
Singapore
Language: English
Trainer: Stefano Persiani
SGD$2,095.00
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Course Information
Instructional Delivery Method: Schedule Digital
Prerequisite & Advanced Preparation: Reading material will be sent prior to the course
LEARN MORE ABOUT THIS TRAINING COURSE
Delivered by Dr. Stefano Persiani
Dr. Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. After years working in academia, Dr. Persiani moved to the pharmaceutical industry and CRO sector holding different positions in R&D at Farmitalia Carlo Erba, Pharmacia, Upjon, and Zambon Group.
Run this course in-house
Informa Connect Academy’s customised training solutions have helped organisations deliver tailored learning in different languages to suit every requirement.