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Overview
About the course
Planning and conducting the first human clinical trial of a new medicine is an important step in the drug development pathway. Preclinical data generated in vitro and in vivo must be interpreted and used in a manner that allows a safe human trial to be conducted.
A sound understanding of the basic scientific principles is paramount but equally important are the basic principles of clinical trial design and regulatory requirements.
This Exploratory Drug Development module at King's College London combines these elements to provide participants with the capability to facilitate the effective design and conduct of exploratory clinical studies with respect to tolerability, safety, pharmacokinetics and pharmacodynamics.
The criteria for ‘go’ / ‘no-go’ decisions, assessment of the risk/benefit ratio, and dose-escalation in single and repeat-dose studies will be discussed with respect to the early clinical development plan and proof-of-concept.
Programme Structure
By the end of this module participants will be able to:- Evaluate the ethical issues relating to the study population in a Phase I trial.
- Critically appraise toxicological and pharmacological data to aid dose selection in Phase 1 clinical trials.
- Create a First-in-Human phase 1 clinical trial design and consider how this may need to be modified when human data become available.
- Compare and contrast early studies in humans with biologics and small molecules.
- Understand the key safety issues involved in a Phase I trial and how these can be assessed and mitigated.
- Be able to interpret pharmacokinetic and safety data generated during a Phase I trial and critically appraise their validity.
- Understand the importance of biomarkers and pharmacodynamic data generated during a Phase I trial.
- Understand the regulatory issues and procedures involved in a phase I trial.
Key information
Duration
- Full-time
- 5 days
Start dates & application deadlines
- Starting
- Apply before
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Language
English
Delivered
On Campus
Disciplines
Chemistry Pharmacy Pharmacology View 24 other Short Courses in Chemistry in United KingdomAcademic requirements
GPA Upper Second Class
English requirements
We are not aware of any English requirements for this programme.
Student insurance
Make sure to cover your health, travel, and stay while studying abroad. Even global coverages can miss important items, so make sure your student insurance ticks all the following:
- Additional medical costs (i.e. dental)
- Repatriation, if something happens to you or your family
- Liability
- Home contents and baggage
- Accidents
- Legal aid
We partnered with Aon to provide you with the best affordable student insurance, for a carefree experience away from home.
Get your student insurance nowStarting from €0.53/day, free cancellation any time.
Remember, countries and universities may have specific insurance requirements. To learn more about how student insurance work at King's College London and/or in United Kingdom, please visit Student Insurance Portal.
Other requirements
General requirements
- Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject.
- The course will suit individuals seeking to develop a practical understanding of clinical pharmacology e.g., pharmaceutical industry physicians, medical affairs and regulatory affairs personnel.
- Attendance at this short course is a required component of the Diploma in Human Pharmacology awarded by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Medicine.
Tuition Fee
To always see correct tuition fees
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International
2590 GBP/fullTuition FeeBased on the tuition of 2590 GBP for the full programme during 5 days. -
National
1670 GBP/fullTuition FeeBased on the tuition of 1670 GBP for the full programme during 5 days.
Living costs for London
1137 - 2157 GBP /month
Living costs
The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.
Funding
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