ECTS credits ECTS credits: 4.5
ECTS Hours Rules/Memories Student's work ECTS: 74.25 Hours of tutorials: 2.25 Expository Class: 18 Interactive Classroom: 18 Total: 112.5
Use languages Spanish, Galician
Type: Ordinary Degree Subject RD 1393/2007 - 822/2021
Departments: Pharmacology, Pharmacy and Pharmaceutical Technology
Areas: Pharmacy and Pharmaceutical Technology, Pharmacology
Center Faculty of Biology
Call: Second Semester
Teaching: Sin docencia (Extinguida)
Enrolment: No Matriculable
- List the regulation and formulation of biotechnological drugs.
- Identify the main biotechnological drugs, their production processes and applications.
- Understand recent advances in innovative drugs and therapies and design strategies for the production of biotechnological drugs.
1. Theory classes program (20 h)
Topic 1 (1h) - Regulatory framework of biotechnological drugs.
Topic 2 (1h) - Authorization of medicines.
Topic 3 (1h) - Development of biological drugs in host cells.
Unit 4 (2h) - Manufacturing methods of biotechnological drugs.
Topic 5 (3h) - Routes of administration of biotechnological drugs.
Unit 6 (2h) - Main groups of biotechnological drugs.
Unit 7 (2h) - Advanced therapies.
Unit 8 (2 h) - Pre-formulation and stability of biotechnological drugs.
Topic 9 (1,5h) - Biotechnological drugs in parenteral forms I.
Topic 10 (1,5h) - Biotechnological drugs in parenteral forms II.
Topic 11 (2 h) - Transmucosal administration of biotechnological products.
Topic 12 (1 h) - Biomaterials in regeneration.
2. Program of interactive classes (12 h)
Seminar 1. Quality in the pharmaceutical industry (2h).
Seminar 2. Efficiency of biotechnological drugs in the current therapeutic framework (2h).
Seminar 3. Clinical trials of biotechnological drugs (2h).
Seminar 4. Introduction of biotechnology in the development of personalized medicine (2h).
Seminar 5. Formulation of biotechnological products (2h).
Seminar 6. Biotechnological drugs (2h).
3. Program of laboratory classes (5h)
Practice 1 is carried out in the laboratory. Practice 2 is carried out in the computer room.
Practice 1. Experimental simulation of plasmatic levels after IV bolus drug administration (2.5h).
Practice 2. Pharmacokinetic modelling (2.5h).
4. Tutorials
Group tutorials to clarify doubts, provide information or guide progress in the acquisition of skills.
Basic
-Crommelin DJA, Sindelar RD, Meibohm B, editors. Pharmaceutical Biotechnology. Cham: Springer; 2019. ISBN: 978-3-030-00709-6.
- Aulton M.E. and Taylor K.M.G. Aulton's pharmaceutics: the design and manufacture of medicines 4th. Ed, Elsevier, 2013.
- M. E. Aulton. Pharmacy: the science of the design of pharmaceutical forms (2nd ed) Madrid. Elsevier, D.L. 2003. ISBN: 84-8174-728-9.
- Martín Brieva, Humberto. Fundamentals of pharmaceutical biotechnology. Madrid. Dextra. 2018. ISBN 9788416898510.
- Ratledge C and Kristiansen B, editors. Basic Biotechnology (3rd ed). Cambridge. Cambridge University Press. 2007. ISBN: 978-0-521-54958-5.
Basic and general competences.
Those that appear in the memory of the degree.
Transversal competences.
CT1 - Think in an integrated way and approach problems from different perspectives.
CT2 - Search, process, analyze and synthesize information from various sources.
CT3 - Organize and plan your work.
CT4 - Interpret experimental results and identify consistent and inconsistent elements.
CT7 - Maintain an ethical commitment.
CT6 - Critically reasoning
CT8 - Adaptation to new situations (resilience).
CS11. Quality concern.
Specific skills
CE12 - Know the fundamentals of cellular and tissue bioengineering, the therapeutic possibilities of regenerative medicine and its current limitations, both technical and ethical.
A) Lectures: Lesson given by the teacher that can have different formats (theory, problems and / or general examples, subject guidelines).
B) Interactive classes: Theoretical / practical class in which applications of the theory, problems and exercises are proposed and solved. Videos with complementary information to the classes are also displayed.
The interactive class program includes a project-based learning activity (PBLA) carried out in small groups where the operation, regulatory status, pharmaceutical and biopharmaceutical aspects of a biotechnological drug are analyzed. This PBLA is delivered as a presentation in pdf format and presented at seminar 6.
C) Tutorials: They will be used to resolve doubts about the different contents of the subject.
D) Practices: The practical classes are divided into two 2.5-hour modules to be carried out in the computer room and laboratory.
MANDATORY EVALUABLE ACTIVITIES:
Written exam. It will consist of between 4 and 6 short questions or problems, and optionally a test module of maximum 20 questions. To pass the subject it is necessary to obtain at least 45% of the maximum mark in this element.
NON-COMPULSORY EVALUABLE ACTIVITIES:
Seminars and PBLA: The grade correspond to a weighted average of the exercises, tasks, and participation in seminar classes (40% of the grade) and the assessment of the work and presentation of the PBLA (60% of the grade). For the assessment of the PBLA it will be necessary to have participated in the work and be present for the presentation of the work in Seminar 6 (except absence for justified reasons). Practice: presence int the practical classes is necessary for their evaluation. Marks will be given based on student participation assessed by assistance checking and the presentation of a small report by the end each session.
Failure to carry out these activities will imply a grade of 0 in parameters B and C of the calculation of the final grade.
The Final Grade (FG) out of 10 is obtained from the following equation: FG = 0.7 * A + 0.2 * B + 0.1 * C.
In this equation, A represents the exam grade, B the seminars and PBLA grade, and C the Practice grade.
To pass the subject it is necessary to obtain a FG equal to or greater than 5. For the second chance assessment, grades B and C (continuous assessment) are retained. Upon request of the interested party, grades B and C may be retained if the subject has been taken in previous academic years.
The student must dedicate 40.5 contact hours to the study of the topics and 72 hours to personal work.
Work regularly.
- The subject is supported through material and activities in the Virtual Classroom. Subject notifications are sent from the News Forum of said Virtual Classroom and students must make sure they can receive them. The MS Teams platform will be used for activities that require direct contact with the teacher such as grupal or individual titorial sessions.
Marcos Garcia Fuentes
Coordinador/a- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacy and Pharmaceutical Technology
- Phone
- 881815450
- marcos.garcia [at] usc.es
- Category
- Professor: University Lecturer
Araceli Tobio Ageitos
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacology
- araceli.tobio.ageitos [at] usc.es
- Category
- Professor: LOU (Organic Law for Universities) PhD Assistant Professor
Anton Leandro Martinez Rodriguez
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacology
- Phone
- 881815484
- antonleandro.martinez [at] usc.es
- Category
- Professor: LOU (Organic Law for Universities) PhD Assistant Professor
Noemi Stefania Csaba
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacy and Pharmaceutical Technology
- noemi.csaba [at] usc.es
- Category
- Professor: University Lecturer
Jesús María González Jartín
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacology
- jesus.gonzalez [at] usc.es
- Category
- Professor: LOU (Organic Law for Universities) PhD Assistant Professor
| Monday | |||
|---|---|---|---|
| 09:00-10:00 | Grupo /CLE_01 | Galician, Spanish | Classroom 09. Barbara McClintock |
| Tuesday | |||
| 09:00-10:00 | Grupo /CLE_01 | Galician, Spanish | Classroom 09. Barbara McClintock |
| Thursday | |||
| 11:00-13:00 | Grupo /CLIS_01 | Spanish, Galician | Classroom 09. Barbara McClintock |
| 05.16.2023 10:00-14:00 | Grupo /CLE_01 | Classroom 04: James Watson and Francis Crick |
| 07.04.2023 10:00-14:00 | Grupo /CLE_01 | Classroom 03. Carl Linnaeus |