Research and Development of New Drugs: From Laboratory to Clinical Practice

- To provide an overview of the overall process of drug discovery and of development of new medicines.
- To give an account of the high throughput procedures used in the screening of new chemical entities (NCE) as drug candidates.
- To describe the pharmacological, toxicological and biopharmaceutical criteria that should be taken into account for the screening of new drugs.
- To present the structure of the preformulation programs and the pharmaceutical development activities.
- To present the structure of the preclinical and clinical studies.
- To give an account of the current concepts of quality assurance in the pharmaceutical industry.
- To describe the procedure and the structure of the dossier needed for registering new medicines.
- To give an account of the objective and the planning of post-marketing clinical studies.

Thematic block I- Discovery of new drugs and development of new medicines. Approach and steps.
Thematic block II- High throughput procedures for screening of new chemical entities (NCE) as drug candidates. Pharmacological, toxicological and biopharmaceutical criteria to take into account for the screening of new drugs.
Thematic block III- Preformulation studies and pharmaceutical development. Approach and objectives. Industrial production of medicines.
Thematic block IV- Preclinical trials. Clinical trials before registration of a new medicine and postmarketing.
Thematic block V- Registration of new medicines. Registration dossiers: quality, safety, efficacy.

- Raviña Rubira, E. Medicamentos. Un viaje a lo largo de la evolución histórica del descubrimiento de fármacos (I y II). Servizo de Publicacións e Intercambio Científico da Universidade de Santiago de Compostela, 2008.
- Preformulation in solid dosage form development. Moji Christianah Adeyeye, Harry G. Brittain (editores). New York : Informa Healthcare, cop. 2008.
- AGEMED web page. http://www.agemed.es/
- Normas de correcta fabricación : medicamentos de uso humano y uso veterinario. Madrid: Ministerio de Sanidad y Consumo, 2008.
- EMEA web page. http://www.emea.europa.eu/htms/human/raguidelines/application.htm
- Ensayos clínicos : diseño, análisis e interpretación. Alvarez Cáceres, Rafael. Madrid: Díaz de Santos, D.L. 2005.

- To understand the overall process of drug discovery.
- To understand the transformation process of a drug in a medicine.
- To acquire skills in the use of selection criteria for new drugs.
- To acquire ability to apply the basic concepts of quality assurance in the pharmaceutical industry.
- To acquire ability to interpret the different sections of a registration dossier.

Lectures, interactive seminars and practical sessions of compulsory attendance.

Attendance at lectures and work done in practical classes and seminars (50%), and final exam consisting in solving case studies related to the subject (50%).


In the event of fraudulent exercises or tests, the provisions of the Regulations for the Evaluation of Students' Academic Performance and Grade Review will apply.

Total ECTS credits: 6, distributed as follows:
- Theory (Assistance to lectures on thematic blocks): Class hours: 30; hours of student personal work: 45. 3 ECTS credits.
- Practice (access to databases, consultation and discussion of AGEMED and EMA documents) Class hours: 16; hours of student personal work: 24. 1.6 ECTS credits.
- Other activities: Preparation of material for seminars: hours of student personal work: 15. Presentations: hours of class: 10. 1 ECTS credits.
- Evaluation (Preparation and resolution of the exam). Class hours: 4; hours of student personal work: 6. 0.4 ECTS credits.

Basic knowledge of English and managing software.

Para los casos de realización fraudulenta de ejercicios o pruebas, se aplicará lo establecido en el Reglamento para la evaluación del desempeño académico de los estudiantes y la revisión de calificaciones.