Drug Development and Pharmaceutical Processes

Recommended Prerequisites

No specific pre-requisites.

Teaching Methods

Theoretical classes: oral exposition, using audiovisual support materials and internet access. Theoretical concepts will be accompanied and supported by application examples and case studies.

Tutorial classes: tasks/projects/monographs selection (proposed by students/teacher), tutorial supervision by teacher (during the whole semester). Students will be organized in groups.

Special seminars (to be presented by specialist guest lecturers - academic/industrial) will be scheduled. Field visits to pharmaceutical companies will be organized.

Learning Outcomes

The main goal of this course is the acquisition/development of basic/specific knowledge/skills in the fields of discovery/development of new drugs/medicines, and of pharmaceutical processing (APIs and medicine manufacturing). The involved regulatory requirements, and particularly “Good Manufacturing Practices” - GMPs, will be covered in detail. A multidisciplinary perspective is always provided. Other course goals are related to the expansion and application of some of the already acquired Chemical Engineering knowledge/skills (transformation and separation processes, quality systems, etc.) into the areas of pharmaceutical technology and pharmaceutical processes. Tasks/projects/monographs on the subjects covered in this course will be proposed and will help to develop students’ synthesis skills. Special seminars (to be presented by specialist guest lecturers - academic/industrial) will be scheduled. Field visits to pharmaceutical companies will be organized.

Work Placement(s)

No

Syllabus

Theoretical component: introduction to drugs and to the pharmaceutical industry; diseases, targets and receptors; basic concepts of Pharmacy; medicines and routes of administration; pharmacodynamics; pharmacokinetics; toxicology; regulatory authorities: Portugal (Infarmed), Europe (EMA), USA (FDA), other: ICH, PIC/S WHO); regulatory issues towards market authorization; non-clinical studies (GLP); clinical studies and trials (GCP); Good Manufacturing Practices (cGMP); primary pharmaceutical processing – API manufacturing; secondary pharmaceutical processing – medicine manufacturing.

Tutorial component: classes involve the tutorial supervision of proposed tasks/projects/monographs (proposed/defined by students/teacher). Students will be organized in groups and will develop these activities during the whole semester. Special seminars (to be presented by specialist guest lecturers - academic/industrial) will be scheduled. Field visits to pharmaceutical companies will be organized.

Head Lecturer(s)

Hermínio José Cipriano de Sousa

Assessment Methods

Assessment
Exam: 40.0%
Synthesis work: 60.0%

Bibliography

Ng, R., Drugs: From Discovery to Approval, 2nd Ed., Wiley-Blackwell, 2008

Bartfai, T., Lees, G.V., Drug Discovery - From Bedside to Wall Street, Elsevier Academic Press, 2006.

Pandit, N.K., Introduction to the Pharmaceutical Sciences, Lippincott Williams & Wilkins, 2006.

Bennett, B., Cole, G. (Eds.), Pharmaceutical Production, An Engineering Guide, Institution of Chemical Engineers (IChemE), 2003.

Swarbrick, J. (Ed.), Encyclopedia of Pharmaceutical Technology, 3rd Ed., Vols 1-3, Informa Healthcare, 2007.

Nally, J.D. (Ed.), Good Manufacturing Practices for Pharmaceuticals, 6th Ed., Informa Healthcare, 2007.

Gad, S.C. (Ed.), Pharmaceutical Manufacturing Handbook: Production and Processes, John Wiley & Sons, 2008.

Hickey, A.J., Ganderton, D., Pharmaceutical Process Engineering, Marcel Dekker, 2001.

Outra bibliografia poderá ser indicada/fornecida durante as aulas da disciplina/Other bibliographic materials may be provided/indicated during course classes.