2024
Pharmaceutical Development II
Name: Pharmaceutical Development II
Code: CMS13753I
3 ECTS
Duration: 15 weeks/78 hours
Scientific Area:
Ciências Farmacêuticas
Teaching languages: Portuguese
Languages of tutoring support: Portuguese
Presentation
Study of the processes, methodologies and strategies applicable to the preparation, development and testing of new biological or biotechnological medicinal products. Analysis of case study situations.
Sustainable Development Goals
Learning Goals
1. Describe and justify the role and importance of the various disciplines involved in the different phases of drug discovery and development of biological and biotechnological drugs.
2. Review and evaluate preclinical and clinical pharmaceutical studies with a general understanding of aim, choice of procedures, results, conclusions and importance.
3. Explain scientific, ethical and market-related considerations of importance in the development of biological and biotechnological drugs.
4. Carry out searches in databases to retrieve information relevant to the development of a new drug.
5. Account for decision points in the drug development process.
6. Artificial intelligence in making early decisions on drug discovery and development.
7. Consider the regulatory requirements for the authorization of experimental drug products and for filling the MA file for biological or biotechnological entities.
2. Review and evaluate preclinical and clinical pharmaceutical studies with a general understanding of aim, choice of procedures, results, conclusions and importance.
3. Explain scientific, ethical and market-related considerations of importance in the development of biological and biotechnological drugs.
4. Carry out searches in databases to retrieve information relevant to the development of a new drug.
5. Account for decision points in the drug development process.
6. Artificial intelligence in making early decisions on drug discovery and development.
7. Consider the regulatory requirements for the authorization of experimental drug products and for filling the MA file for biological or biotechnological entities.
Contents
1. Theoretical programme
a. Introduction
b. Artificial intelligence on discovery and development of biological and biotechnological drugs
c. Drug discovery of pharmacological medicinal products
d. Proteomics and genomics for drug development of biological and biotechnological drugs
e. Drug delivery of biological and biotechnological drugs
f. Compound selection for delivery and clinical effect
g. Clinical study design and start-up activities. Ethical issues.
h. Clinical trials: phase 1, phase 2 and phase 3
i. Regulatory considerations for filing an investigational new application for biological and biotechnological drugs
j. Considerations with phase IV clinical trials
k. New application, filing and product labelling for biological and biotechnological drugs
2. Practical programme
a. Selection of one recent new biological or biotechnological product application
b. Study of the pharmaceutical development accomplished
c. Oral presentation on the pharmaceutical development options.
a. Introduction
b. Artificial intelligence on discovery and development of biological and biotechnological drugs
c. Drug discovery of pharmacological medicinal products
d. Proteomics and genomics for drug development of biological and biotechnological drugs
e. Drug delivery of biological and biotechnological drugs
f. Compound selection for delivery and clinical effect
g. Clinical study design and start-up activities. Ethical issues.
h. Clinical trials: phase 1, phase 2 and phase 3
i. Regulatory considerations for filing an investigational new application for biological and biotechnological drugs
j. Considerations with phase IV clinical trials
k. New application, filing and product labelling for biological and biotechnological drugs
2. Practical programme
a. Selection of one recent new biological or biotechnological product application
b. Study of the pharmaceutical development accomplished
c. Oral presentation on the pharmaceutical development options.
Teaching Methods
1. Theoretical presentations
4. Autonomous research of pharmaceutical development strategies
5. Public presentation and discussion of applied pharmaceutical development.
The evaluation of the theoretical component, by continuous assessment of frequencies or final examination, will have a relative weight of 75%.
The evaluation of the monograph and its public presentation will have a relative weight of 25%. If and when it is possible to do all teaching in the classroom, the relative weight of the monograph will be reduced to 15% and 10% will be attributed to the attendance of students to all the components.
4. Autonomous research of pharmaceutical development strategies
5. Public presentation and discussion of applied pharmaceutical development.
The evaluation of the theoretical component, by continuous assessment of frequencies or final examination, will have a relative weight of 75%.
The evaluation of the monograph and its public presentation will have a relative weight of 25%. If and when it is possible to do all teaching in the classroom, the relative weight of the monograph will be reduced to 15% and 10% will be attributed to the attendance of students to all the components.
Certificações
