UMH - DEVELOPMENT OF ORAL MEDICATION: BIOPHARMACEUTICAL AND PHARMACOKINETIC OPTIMIZATION

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DEVELOPMENT OF ORAL MEDICATION: BIOPHARMACEUTICAL AND PHARMACOKINETIC OPTIMIZATION

Course

Code: 3622

Degree: Master's in Biotechnology and Bioengineering

Faculty of Experimental Sciences

Year: Year 1 of Master's in Biotechnology and Bioengineering

Semester: Fall

Type: Elective

Language: Spanish

ECTS credits: 3

Lecture: 2

Laboratory: 1

Hours: 75

Directed: 30

Shared: 18

Autonomous: 27

Subject matter: Biomedical Biotechnology and Bioengineering

Module: Elective

Course instructors are responsible for the course content descriptions in English.

Description

Review of preclinical and clinical development of drugs destined to be administered orally. Description of procedures for evaluating and improving pharmacokinetic and biopharmaceutical characteristics of new molecules and their transformation into medicine, from the screening of optimal molecules to the design and evaluation of drug formulations. Use of simple tools (spreadsheet-based) to characterize kinetic parameters and statistical comparisons applicable for evaluating bioavailability, bioequivalence, and simulation of biological processes.

Faculty

Name	Coordinator	Lecture	Laboratory
BERMEJO SANZ, MARIA DEL VAL	■	■	■
LOZOYA AGULLO, ISABEL		■	■
GONZALEZ ALVAREZ, MARIA ISABEL		■	■
GONZALEZ ALVAREZ, MARTA		■	■

Competencies and learning outcomes

General competencies

Apply acquired knowledge to solve problems in new or unfamiliar environments within broader (or multidisciplinary) contexts related to biotechnology and bioengineering.
Ability to integrate knowledge and handle the complexity of making judgments based on information that, although incomplete or limited, includes reflections on social and ethical responsibilities linked to the application of knowledge and judgments on biotechnology and bioengineering.
Ability to communicate conclusions and the knowledge and latest rationale that sustain them to specialized and non-specialized audiences in a clear and unambiguous manner.
Develop the capacity to continue studying in a mostly self-directed or autonomous manner.
Capacity to manage and organize information.
Have the ability to design and propose experiments in biotechnology and bioengineering.
Be able to critically assess and discuss information.
Be capable of coming up with new ideas to address problems related to biotechnology and bioengineering.

Specific competencies

Knowledge and skills in the use of the most common basic and advanced experimental techniques in the field of biotechnology and bioengineering and their applications for solving specific problems in this area.
Demonstrate skills to quantify phenomena and processes in biotechnology and bioengineering.
Be able to critically interpret and discuss results published and/or disseminated in journals, at conferences, and in other scientific forums.
Technical and scientific competence to ensure the achievement of accurate and reproducible results from which valid conclusions can be drawn in the scientific area of specialization within the field of biotechnology and bioengineering.
The ability to design a research project using the scientific method, compiling and evaluating information critically to solve problems in biotechnology and bioengineering.
The ability to transfer knowledge of biotechnology and bioengineering to finding effective industrial, therapeutic, or preventive interventions, preparing the application request for a patent for a biotechnological invention.

Objectives (Learning outcomes)

Identify relevant physicochemical characteristics that determine the oral absorption of a substance.
Select the appropriate methodology for the study of intestinal absorption and experimental design
Analysing and interpreting test results of absorption and bioavailability preclinical and clinical
Designing experimental studies for evaluation of new drug delivery systems
Using simulation methodologies of experimental data understanding the basics of mathematical modeling as a tool to study kinetic processes.

Teaching units

Basic bibliography

Methodology and grading

Methodology

Cooperative learning: Develop active learning through cooperative working strategies among students and promote shared responsibility to reach group goals.
Lecture: Pass on knowledge and activate cognitive processes in students, encouraging their participation.
Problem-based learning: Develop active learning strategies through problem solving that promote thinking, experimentation, and decision making in the student.
Project-based learning: Realization of a project to solve a problem, applying acquired learning and promoting abilities related to planning, design, performing activities, and reaching conclusions.

Grading

A) The driving theory test will be a test of multiple-choice questions (multiple choice) with a penalty for wrong answers (factor -0.33) B) The practical examination will consist of problem solving data analysis using spreadsheets and reasoned biopharmaceutical evaluation of a substance based on its properties. C) Formative assessment will take place during practice sessions and by providing solved problems.

Weighting:

A: 40%; B:30% C:30%

Correction criteria

Criterios de corrección

Para el examen de respuesta múltiple: 3 preguntas incorrectas restan 1 correcta.

Parte práctica: La clasificacion Biofarmaceutica provisional de una sustancia ha de hacerse de manera razonada. Se evaluará:

la clasificación correcta 20%.

los cálculos necesarios para la misma 30%.

la selección de la información necesaria para realizar los cálculos 30%.

La adecuada presentación en forma de informe científico con la necesaria bibliografía y análisis crítico de las limitaciones de los resultados 20%.

La evaluacion formativa consistirá en la entrega de los ejercicios resueltos correctamente en las sesiones informáticas

About: DEVELOPMENT OF ORAL MEDICATION: BIOPHARMACEUTICAL AND PHARMACOKINETIC OPTIMIZATION

General competencies

Specific competencies

Objectives (Learning outcomes)

Lecture topics

Teaching units

Course contents

Basic bibliography

Complementary bibliography

Links

Software

Methodology

Grading

Correction criteria