SMIMB1151U Clinical Pharmacology and Biostatistics

Volume 2025/2026
Education

Master's Programme in Industrial Drug Development - compulsory

 

See course webpage for course dates

Compulsory for Master of Industrial Drug Development (MIND) students, elective for other part-time master's students at the Faculty of Health and Medical Sciences (subject to study board approval). Open for freelance students who meet the admission criteria.

The course is intended for MIND students and other professionals in drug development and health care.

Content

The course covers the transition process of drug candidates from the preclinical stage to clinical evaluation. The red thread comprises the writing of a full trial protocol done in groups. The theoretical aspects cover clinical trial designs, PK/PD methodology, selection of special patient populations, and regulatory requirements.  Special emphasis will be put on biostatistics including theory, considerations and hands-on calculations for practical use. Aspects special for biopharmaceuticals will be highlighted. Further an introduction will be given to in silico trial simulation.

Learning Outcome

The objective of this course is to give participants a thorough understanding of clinical pharmacological considerations during drug development. This will prepare the participants to take active part in the planning, organization and execution of a clinical trial.

Upon completion of the course, participants are expected to be able to:

Knowledge

  • outline comprehensively the clinical pharmacological considerations made during drug development
  • explain comprehensively the transition process from nonclinical studies to human clinic
  • demonstrate knowledge of basic clinical pharmacology as prerequisites for planning a clinical trial
  • give an account of pros and cons for available trial designs
  • demonstrate knowledge of pharmacometrics to optimise trial design
  • define the biostatistical concepts for a clinical trial
  • give an account for the value and limitation of use of surrogate endpoints
  • describe the regulatory requirements for conducting a clinical trial


Skills

  • master the design, the organisation and writing of a protocol on a clinical trial to be valid for the authorities and the clinicians
  • calculate the biostatistics and the power of a clinical study
  • analyse and react on the results of available pharmacometric information
  • identify and define special patient populations for the trial
  • substantiate the design chosen for a clinical study


Competencies

  • independently to plan and critically evaluate a clinical trial
  • translate safely the dosing information from the nonclinical to the clinical setting
  • conduct a clinical trial according to the regulatory requirements
  • liaise and communicate professionally with stakeholders involved in execution of a clinical trial using relevant terminology

Selected chapters in Pharmaceutical Medicines ed. J.P Griffin 7th ed. 2013 or similar textbook, relevant scientific articles, guidelines, notes on biostatistics, hand-outs of presentations from lectures. Total approximately 300 pages.

Applicants must meet the following criteria:
• A bachelor's degree, a professional bachelor’s degree, a diploma degree, a master’s degree or equivalent within chemistry, biochemistry, pharmacy, medicine, biomedicine, human biology, molecular biology, veterinary sciences, health sciences, nursing, engineering or equivalent.
• At least two years of relevant work experience related to development of medicines
• Proficiency in English
It is recommendable to have completed the MIND course Pharmacology before taking this course.
Lectures, tutorials and group discussions.
Besides the attendance in the class, some evenings between the two course weeks should be set aside for being able to prepare and write the trial protocol. This because the protocol is central for the achieving the learning outcome of the course
  • Category
  • Hours
  • Lectures
  • 30
  • Preparation
  • 59
  • Theory exercises
  • 20
  • Project work
  • 30
  • Exam
  • 1
  • Total
  • 140
Oral
Collective
Continuous feedback during the course of the semester
Feedback by final exam (In addition to the grade)
Peer feedback (Students give each other feedback)
Credit
5 ECTS
Type of assessment
Written assignment
Type of assessment details
During the course, the students work on a trial protocol (15-25 pages) based on a short description and a template that specify the essential elements required (handed out at the start of the course). The trial protocol is written in groups with clearly defined contributions from each student, and is submitted via Absalon to the course responsible at the end of teaching on Wednesday of the last course week.
The groups also prepare a presentation of the protocol. On the last course day, each student presents part of the protocol in plenum allowing feedback and questions from the fellow peers, the course leader and the external examiner.
A week after the course, each student hands in via Digital Exam a two-part assignment consist of A. a 2-page assignment that contains reflections on the learning during the course; and B. the trial protocol.
The assessment is based on three elements: The protocol and presentation as a whole, the student’s individual contribution and the individual assignment, according to the knowledge, skills and competence criteria specified.
Aid
All aids allowed

All aids allowed for preparation including access to internet and the use of Generative AI.

It is the responsibility of the student to ensure the accuracy, integrity, and originality of the text, including ensuring that the text is not factually incorrect, plagiarized, or contains copyrighted material. AI/LLM’s may not be used as an actual author or a scientific source cf. Vancouver Guidelines.

Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

See exam schedule.

Re-exam

The exam form for the reexam is the same as the ordinary exam, except that the assignment is handed in before or on the day of the oral presentation. See dates in the exam schedule.

Criteria for exam assesment

 

The purpose of the examination is to test that the examinee has a broad knowledge and comprehension of clinical pharmacology in drug development. To achieve grade 12 the student must be able to:

Knowledge

  • understand the transition process from nonclinical studies to human clinic
  • describe the content for full protocol for a clinical trial according to current regulatory guidelines and GCP
  • understand basic clinical pharmacology concepts, pharmacometrics and biostatistics
  • understand proof of concept of efficacy and safety in the clinical setting
  • explain the use of clinical hard endpoints and the use of biomarkers as surrogate endpoints
     

Skills

  • Evaluate conditions and designs for performing First-in-human studies, exploratory and confirmatory trials

  • apply the correct biostatistical concepts and calculations for a clinical  trial

  • select groups at risk for a trial

  • evaluate regulatory requirements for a given trial

Competences

  • Translate preclinical knowledge into a full trial protocol

  • Respond to regulatory requirements for a given trial

  • Integrate the correlation between pharmacokinetics, pharmacodynamics and safety of a drug candidate into a dosage and treatment scheme

  • Take responsibility for planning and setting up a correct clinical trial to be used for authorization purpose