CLINICAL PHARMACOLOGY & EARLY HUMAN STUDIES - 2017/8
Module code: PHMM037
School of Biosciences and Medicine
TRINDER S Dr (Biosc & Med)
Number of Credits
FHEQ Level 7
Module cap (Maximum number of students)
Overall student workload
Workshop Hours: 6
Independent Study Hours: 120
Lecture Hours: 26
Tutorial Hours: 8
|Assessment type||Unit of assessment||Weighting|
|Coursework||Home Assignment - Question 1||50|
|Coursework||Home Assignment - Question 2||50|
Prerequisites / Co-requisites
The module provides the principles of clinical pharmacology and how they are applied in the design and conduct of clinical studies. In addition the module will addresses conprehensively legal, ethical, moral and regulatory requirements of study design in healthy human volunteer subjects. This module is central to both the Pharmaceutical Medicine and Pharmaceutical Medicine with Clinical Pharmacology routes.
Systematic overview of where clinical pharmacology fits into the clinical development programme.
Systematic overview of ADME (PK) in relation to the plasma concentration versus time curve. Pharmacogenomics, age, renal and hepatic affects.
Systematic overview of Pharmacodynamics (PD). In relation to the plasma concentration versus time curve. Pharmacodynamic markers, bioavailability, bioequivalence, pharmacogenomics, age, renal and hepatic affects
Comprehensive study design for early human studies, safety considerations.
Complex issues in relation to ethics, Declaration of Helsinki, informed consent, Good Clinical Practice and ICH guidelines.
|1||A systematic understanding of knowledge and a critical awareness of clinical pharmacology and how they are applied in developing a new medicine with regard to current problems and new insights.||KCT|
|2||A comprehensive understanding of the techniques of simple non-compartmental pharmacokinetic analysis of blood/plasma/serum concentration data (to construct a blood/plasma/serum concentration versus time curve and derive/interpret the key parameters AUC, t1/2, Tmax, Cmax and VD).( C, K, T)||KCT|
|3||Thorough interpretation of concentration-effect relationships.||KCT|
|4||Critical evaluation of the sources of PK and PD variability and the methods of assessing these.||KT|
|5||Critical evaluation and development of a drug development plan and design key clinical pharmacology studies based on the target profile, preclinical investigations and other data.||CPT|
|6||Systematic understanding of the key ethical and quality issues in doing early human studies.||KT|
C - Cognitive/analytical
K - Subject knowledge
T - Transferable skills
P - Professional/Practical skills
Indicative content includes:
Pre-clinical toxicology testing of drugs
Clinical Pharmacology in Drug Development
Declaration of Helsinki: Ethics and standards in human pharmacology studies
Recording and assessing adverse events in clinical studies
First time to humans and early Clinical Pharmacology studies
ADME (Absorption, Distribution, Metabolism and Excretion)
Bio-availability and bio-equivalence
Determining key PK parameters in Excel (Tmax, Cmax, T1/2, AUC, VD, clearance)
General principles of using pharmacodynamics measures in clinical pharmacology studies
Biomarkers in exploratory drug development
Proof of concept studies
Clinical pharmacology requirements in a regulatory submission for approval of a new drug and in a Summary of Products Characteristics
Methods of Teaching / Learning
The learning and teaching strategy is designed to:
Introduce the principles of clinical pharmacology in relation to drug development and to develop these principles by the construction of a clinical development plan during the module for a new drug entity
The learning and teaching methods include:
Lectures 26 hours
Syndicate work 6 hours
Case studies 2 hours
Student presentations 6 hours
This is an intense 5 day module from 09:00-18:30 hours each day.
The assessment strategy is designed to provide students with the opportunity to demonstrate
• A systematic understanding of knowledge and a critical awareness of clinical pharmacology and how they are applied in developing a new medicine with regard to current problems and new insights.
• A comprehensive understanding of the techniques of simple non-compartmental pharmacokinetic analysis of blood/plasma/serum concentration data (to construct a blood/plasma/serum concentration versus time curve and derive/interpret the key parameters AUC, t1/2, Tmax, Cmax and VD).
• Interpretation of concentration-effect relationships.
• Critically evaluation of the sources of PK and PD variability and the methods
• Evaluation and development of a drug development plan and design key clinical pharmacology studies based on the target profile, preclinical investigations and other data.
• Systematic understanding of the key ethical and quality issues in doing early human studies
Thus, the summative assessment for this module consists of:
Two post module assignments which are two units of assessment. Each unit is weighted at 50% of the total module mark and the pass mark is 50% overall.
Formative assessment and feedback
Students are given formative feedback each morning of day 2, 3, 4 and 5 of the module when they give their syndicate presentations from the previous evenings syndicate work. In addition on day 5 the syndicate presentations are to the module teaching team in the form of a clinical development plan for the drug(s) studied.
Reading list for CLINICAL PHARMACOLOGY & EARLY HUMAN STUDIES : http://aspire.surrey.ac.uk/modules/phmm037
Please note that the information detailed within this record is accurate at the time of publishing and may be subject to change. This record contains information for the most up to date version of the programme / module for the 2017/8 academic year.