Teaching Responsibility
LJMU Schools involved in Delivery:
Pharmacy & Biomolecular Sciences
Learning Methods
Lecture
Seminar
Workshop
Module Offerings
6004PHASCI-JAN-CTY
Aims
To develop awareness and understanding of preclinical testing, management and regulation of clinical trials in the process of drug development as well the procedures used in the toxicity and safety assessment of cosmetic products.
Learning Outcomes
1.
Evaluate the key processes involved in preclinical and clinical testing during drug development in accordance with GCP-ICH guidelines.
2.
Critically discuss the importance of preclinical and computational toxicity testing in pharmaceutical and cosmetic product development.
3.
Identify and evaluate the challenges with respect to patient recruitment and retention in the different phases of Clinical Trials and the ethical issues of outsourcing of clinical trials.
Module Content
Outline Syllabus:Preclinical toxicity testing
Computational toxicity
Adverse Reactions
Toxicity and safety assessment of cosmetic products
Clinical trial documentation
Clinical Trial design
Patient recruitment and retention
Outsourcing of clinical trials
Ethics and Law
GCP-ICH
Standard Operating Procedures
Trial Closedown and Clinical Trial Data Dissemination
Regulatory requirements for the safety of cosmetic and pharmaceutical products
Module Overview:
The aim of this module is to gain an awareness and understanding of preclinical testing and management and regulation of clinical trials in the process of drug development.
The aim of this module is to gain an awareness and understanding of preclinical testing and management and regulation of clinical trials in the process of drug development.
Additional Information:The module will run in parallel and complement the Industrial Product Development module in semester 2 of Level 6