Università degli Studi di Urbino Carlo Bo / Portale Web di Ateneo


QUALITY BY DESIGN IN PHARMACEUTICAL DEVELOPMENT
QUALITY BY DESIGN: APPLICAZIONE DI DISEGNI SPERIMENTALI FATTORIALI NELLO SVILUPPO FARMACEUTICO

A.Y. Credits
2024/2025 3
Lecturer Email Office hours for students
Annalisa Aluigi From Monday to Friday, by appointment via email
Teaching in foreign languages
Course with optional materials in a foreign language
This course is entirely taught in Italian. Study materials can be provided in the foreign language and the final exam can be taken in the foreign language.

Assigned to the Degree Course

Industrial Pharmacy (LM-13)
Curriculum: PERCORSO COMUNE
Date Time Classroom / Location
Date Time Classroom / Location

Learning Objectives

The main objective of the course is to provide the student with the theoretical foundations and operational tools to design and plan experiments as well as to analyze data and optimize processes in chemical research.

Various design tools will be discussed underlying their respective differences, advantages, and disadvantages. Fundamentals of multivariate analysis to treat complex systems in the field of chemistry and pharmacology will be addressed.  A practical activity with the Stat Ease DesignExpert software will complete the course.

The student will therefore be able to evaluate the characteristics of the several approaches for screening and optimization of processes in chemical research. The student will also be able to suggest the choice of the methodology and tools for experimental design most suitable to address a specific problem.

Program

1. Introduction to the Design of Experiments (DOE)

2. Screening Designs and their applications

3. Optimization Designs and their applications

4. Responses Analysis

5. Practical activities

Learning Achievements (Dublin Descriptors)

D1 – KNOWLEDGE AND ABILITY TO UNDERSTAND.

  • describe the main algorithms presented in the course for correct use
  • describe the fundamental parameters for evaluating the result
  • describe the advantages and disadvantages of the different algorithms studied

D2 - ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING.

  • to select the most suitable method to address a data analysis problem
  • to predict what type of information will be possible to extract from the data under examination
  • to evaluate the possibility of alternative design tools to solve the problem
  • to concretely apply the selected design tools and calculate the relevant informative statistical parameters

D3 - INDEPENDENCE OF JUDGMENT.

  • to acquire the knowledge and skills capable of developing a critical understanding of main tools for the design of experiments
  • to select the techniques and statistical parameters useful for extracting specific information from the data under examination
  • to draft and justify a critical discussion on the methods used and the information obtained from the data analysis

D4 - COMMUNICATION SKILLS.

  • To be able to communicate and transmit the concepts and notions learned during the training activity with appropriate terms and appropriate examples.

D5 – LEARNING ABILITY.

  • To understand the different techniques studied and their methodological placement for the purpose of correct use aimed at the problem to be solved.

Teaching Material

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

Teaching, Attendance, Course Books and Assessment

Teaching

Classroom lessons supported by the projection of the teaching materials.

Innovative teaching methods

Flipped Lessons

Workin group

Attendance

Attendance at lessons is not mandatory but is strongly recommended on a regular basis to encourage both interaction in the classroom and the acquisition of knowledge and skills.

Course books

Design and Analysis of Experiments - DOUGLAS C. MONTGOMERY - Eighth Edition - John Wiley & Sons, Inc.-ISBN 978-1-118-14692-7

Assessment

Written exam followed by an oral interview.

The written test will be a semi-structured test consisting of 3 open questions and 1 exercise, lasting 2 hours.

The objective of the open questions is to ascertain the mastery of basic knowledge relating to the topics of the course through the assessment of the ability to precisely define theoretical principles and fundamental concepts. The objective of the exercise is to ascertain the ability to apply knowledge, deal with complex situations, and make connections between topics covered by the teaching program.

Open questions and exercises will be evaluated with a different weight score: up to 8 points for open questions and up to 9 points for the exercise.

The oral interview, which can be quantified on average in 20 minutes, will start from a comment on the written test and will serve both to assess communication skills and to ascertain the ability to apply knowledge and concepts relating to the topics of the course.

Both the written test and the oral exam will be evaluated with a mark out of thirty. The final grade will derive from the oral exam, also taking into consideration the outcome of the written exam.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

Additional Information for Non-Attending Students

Teaching

Non-attending students can use the Moodle platform (Blended Learning UniUrb-CISDEL)

Attendance

Non-attending students can use the Moodle platform (Blended Learning UniUrb-CISDEL)

Course books

To give the opportunity to students and non-attending students to compensate with independent study carried out during the lessons, the following materials referring to the same contents of the program in order to promote full understanding:

Design and Analysis of Experiments - DOUGLAS C. MONTGOMERY - Eighth Edition - John Wiley & Sons, Inc.-ISBN 978-1-118-14692-7

Assessment

Written exam followed by an oral interview.

The written test will be a semi-structured test consisting of 3 open questions and 1 exercise, lasting 2 hours.

The objective of the open questions is to ascertain the mastery of basic knowledge relating to the topics of the course through the assessment of the ability to precisely define theoretical principles and fundamental concepts. The objective of the exercise is to ascertain the ability to apply knowledge, deal with complex situations, and make connections between topics covered by the teaching program.

Open questions and exercises will be evaluated with a different weight score: up to 8 points for open questions and up to 9 points for the exercise.

The oral interview, which can be quantified on average in 20 minutes, will start from a comment on the written test and will serve both to assess communication skills and to ascertain the ability to apply knowledge and concepts relating to the topics of the course.

Both the written test and the oral exam will be evaluated with a mark out of thirty. The final grade will derive from the oral exam, also taking into consideration the outcome of the written exam.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

« back Last update: 02/07/2024

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