Master of Science Model-based Drug Development
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Owner/Developer: University of Manchester
|Description:||Our MSc Model-based Drug Development course provides the knowledge and skills for making evidence-based decisions at various stages of drug development. It covers the scientific and regulatory aspects of evaluating a drug, with emphasis on the use of modelling and simulation methods. You will learn why these methods are so highly valued by industry and regulatory authorities as effective, cost-saving, decision-making tools. Learning is reinforced via hands-on application of the skills to real data. The course has been developed with an emphasis on mechanistic approaches to assessing and predicting pharmacokinetics and pharmacodynamics (PKPD), such as physiologically-based pharmacokinetics (PBPK) . As this comes under the general umbrella of systems biology, you will be able to apply your knowledge of modelling and simulation in various areas of research within the pharmaceutical industry. Full-time students benefit from immersion in the varied biomedical research environment at The University of Manchester, including interaction with research staff at the renowned Centre for Applied Pharmacokinetic Research . Alternatively, part-time students already working in the pharmaceutical industry can take advantage of the flexible, distance learning mode of the course, which allows you to fit study around other commitments.|
Hands-on training, Lecture, Recorded tutorial, Webinars, Workshops, Other
1 year full time or 2 years part time
Academic entry qualification overview
We require a relevant first degree (minimum Lower Second or equivalent) from a reputable internationally recognised institution.
English language students whose first language is not English require a minimum of one of the following:
IELTS 6.5 with at least 6.0 in writing
internet-based TOEFL of 90 with a minimum of 22 in each component.
We may also accept evidence of a confirmed place on a University Pre-sessional English language course if your current IELTS scores are:
minimum 6.0 overall with 6.0 in writing plus enrolment and attendance on the 5-week pre-sessional course (PS5);
minimum 5.5 overall with 5.5 in writing plus enrolment and attendance on the 10-week pre-sessional course (PS10).
English language test validity
Some English Language test results are only valid for two years. Your English Language test report must be valid on the start date of the course.
In vitro methods, Computational methods
Full coverage (a dedicated course)
|Details on the topic or technology covered:||
The course focuses on the following topics.
Pharmacokinetics: addressing how a drug dose is administered to the body and the fate of drug molecules that enter the body.
Pharmacodynamics: addressing the chemical and physiological response of the body to drug.
Pharmacometrics: the science that quantifies drug, disease and trial information to aid efficient drug development and/or regulatory decisions (definition used by the US FDA).
Systems pharmacology: analysis of interactions between drug and a biological system, using mathematical models.
In vitro: in vivo extrapolation using physiologically based pharmacokinetic models (IVIVE-PBPK).
Teaching and learning
The course emphasises the development of problem-solving skills. A large portion of the learning involves structured problems requiring you to apply theory and practical skills to solve typical problems that arise in drug development.
Course unit details
The course includes the following units:
YEAR 1 (full-time)
Term 1 (September to January)
Unit 1a: Introduction to clinical trials (15 credits) . This online Unit provides an overview of the drug development process followed by in-depth coverage of scientific, statistical and regulatory considerations in the design and interpretation of clinical trials.
Unit 1b: Basic Pharmacokinetics and Pharmacodynamics (15 credits). This unit provides information on how drugs get into the body, how they get around the body and how they are removed from the body
Unit 2: In Vitro - In Vivo Extrapolation in ADME (30 credits). The applications of modelling and simulation have been limited to the so-called phase I-III of drug development. This unit provides information on modelling and simulation as applied to extrapolating data from in vitro systems to the in vivo conditions (IVIVE) prior to phase I.
Term 2 (February to May)
Unit 3: Data Analysis in PKPD (30 credits) This addresses the specialised area of modelling that combines mathematical and statistical knowledge in data fitting with the sound knowledge of the human body as a system. The unit emphasises the value and implementation of mechanistic models. You will be introduced to different types of modelling packages and learn how to choose which package is best for a given application.
Unit 4: Advanced topics in modelling and simulation (30 credits) This unit focuses on the elements that make up a successful modelling and simulation project. We consider the scientific and commercial rationale for undertaking a modelling project, and how these rationales then guide the project design. After reviewing case studies which illustrate the characteristics of a successful project, you will create a research proposal on a topic of current importance in the general area of modelling, simulation and data analysis. The primary aim should be to identify a gap in knowledge and investigate this area by proposing a detailed research project.
Term 3 (May to September)
Unit 5: Supervised Research Project/Dissertation (60 credits): This unit follows on directly from the research proposal in modelling and simulation (Unit 4). You will require both an academic and an industrial supervisor and will carry out the research project (typically at a place of work) proposed in Unit 4, ie on a topic of current interest that addresses issues raised in their research proposal.
Course content for part-time mode
If you are planning to complete the course in 24 months, the content will be delivered in the following sequence:
Unit 1a: Introduction to Clinical trials
Unit 1b: Basic Pharmacokinetics and Pharmacodynamics (PKPD)
Unit 3: Data Analysis in PKPD
Unit 2: In Vitro - In Vivo Extrapolation in ADME
Unit 4: Advanced topics in modelling and simulation
Unit 5: Supervised research, culminating in MSc dissertation
The aim of the course is to provide specialist knowledge and skills that are highly relevant for a career linked to drug development and pharmaceutical industry.
It is designed for science, engineering or mathematics graduates who want to acquire:
awareness of the commercial and regulatory factors in drug development;
understanding of the physiological, chemical, and mathematical foundations used to define the safe and effective use of potential medicines;
training in the use of mathematical modelling and simulation methods to guide drug development.
The course aims to:
provide background information on the theory and methods for quantitative assessment of drug absorption, distribution and elimination;
provide an understanding of the role of pharmacometrics in the process of drug development;
provide background information on in vitro assays used to characterise ADME properties of new drug entities;
indicate the mathematical framework that is capable of integrating in vitro information with knowledge of the human body to predict pharmacokinetics;
provide familiarity and experience of using different software platforms related to pharmacometric data analysis including R, Phoenix, NONMEM, MATLAB, Simcyp, WinBUGS and MONOLIX;
equip you to reflect upon influential research publications in the field, to critically assess recent published literature in a specific area;
provide awareness of the elements of a convincing research proposal based on modelling and simulation;
provide the opportunity to undertake a project and carry out original research.
|Accreditation body and/or authority that approved the education or training:||
University education and ERT
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