Tantargy

Data

Official data in SubjectManager for the following academic year: 2025-2026

Topic

Aim of this course is to introduce biopharmaceutical aspects of medicines taking into account dosage forms and routes of administration. Basic pharmacokinetic aspects (kinetics of active agents, compartmental analysis, routes of administration), some in vitro and in silico biopharmaceutical practices (using special biopharmaceutical softwares) are presented, bioequivalence studies of medicines are discussed. Students learn to design and develop pharmaceutical dosage forms according to biopharmaceutical requirements. Single and repeated dosing calculations are discussed according to pharmaceutical and physiological aspects.

Lectures

• 1. Subject and general approach of biopharmacy - Pál Szilárd
• 2. Subject and general approach of biopharmacy - Pál Szilárd
• 3. Drug delivery systems and the input options - Pál Szilárd
• 4. Drug delivery systems and the input options - Pál Szilárd
• 5. Biopharmaceutical classification of substances and pharmaceutical preparations - Pál Szilárd
• 6. Biopharmaceutical classification of substances and pharmaceutical preparations - Pál Szilárd
• 7. Biopharmaceutical basics of drug qualification I (drug liberation studies) - Pál Szilárd
• 8. Biopharmaceutical basics of drug qualification I (drug liberation studies) - Pál Szilárd
• 9. Biopharmaceutical basics of drug qualification II (dissolution and absorption models) - Pál Szilárd
• 10. Written test - Pál Szilárd
• 11. Biopharmaceutical basics of drug qualification II. (IVIVC, original and generic preparations) - Pál Szilárd
• 12. Biopharmaceutical basics of drug qualification II. (IVIVC, original and generic preparations) - Pál Szilárd
• 13. LADME system and its control options I - Pál Szilárd
• 14. LADME system and its control options I - Pál Szilárd
• 15. LADME system and its control options II - Pál Szilárd
• 16. LADME system and its control options II - Pál Szilárd
• 17. Written test - Pál Szilárd
• 18. Written test - Pál Szilárd
• 19. Biopharmaceutical basics of medicinal therapy I (dermal and transdermal therapy) - Kása Péter
• 20. Biopharmaceutical basics of medicinal therapy I (dermal and transdermal therapy) - Kása Péter
• 21. Biopharmaceutical basics of medicinal therapy II (eye, nasal and ear preparations) - Pál Szilárd
• 22. Biopharmaceutical basics of medicinal therapy II (eye, nasal and ear preparations) - Pál Szilárd
• 23. Biopharmaceutical basics of medicinal therapy III (hormonal disorders) - Pál Szilárd
• 24. Biopharmaceutical basics of medicinal therapy III (hormonal disorders) - Pál Szilárd
• 25. Biopharmaceutical basics of medicinal therapy IV (chronotherapy, cardiovascular diseases, asthma) - Pál Szilárd
• 26. Biopharmaceutical basics of medicinal therapy IV (chronotherapy, cardiovascular diseases, asthma) - Pál Szilárd
• 27. Biopharmaceutical basics of medicinal therapy V (specific medicinal therapy) - Kása Péter
• 28. Written test - Pál Szilárd

Practices

Seminars

Reading material

Obligatory literature

Literature developed by the Department

Notes

Recommended literature

Leon Shargel, A. B.C: .Applied Biopharmaceutics and Pharmacokinetics, Yu, Stamford

Susanna Wu-Pong, Yon Rojanasakul: Biopharmaceutical Drug Design and Development, Humana Press

Gilbert S. Banker, Christopher T. Rhodes: Modern Pharmaceutics, Marcel Dekker Inc., New York- Basel

www.gytk.pte.hu

www.sciencedirect.com

Conditions for acceptance of the semester

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Mid-term exams

Conditions for the acceptance of the semester are as follows:

Students are required to complete 2 written assessments during the semester on predetermined dates. The cumulative result of these assessments must be at least 60.1%. The institute provides an opportunity to make up any missed assessments; failure to take advantage of this opportunity results in a grade of 0% for that assessment. If the combined result of the two written assessments is below 60.1%, two opportunities for improvement are provided, in accordance with the Code of Studies and Examinations. The first retake assessment must achieve a minimum grade of 60.1%. If the first retake assessment is unsuccessful/insufficient, the second retake assessment must also achieve at least 60.1% for semester acceptance and eligibility for examination (provided that absences have not exceeded the specified limit).

Making up for missed classes

Students must fulfil requirements determined by the Code of Studies and Examinations.

Exam topics/questions

Students will receive the topic lists in the Institute and/or on the website.

At the end of semesters, students take oral exam.Exams is preceded by the "Minimum Test" (MT). To write the MT, students have at most 30 minutes, and will be evaluated by percentage. Those students, who achieve less than 60% in MT, will get unsatisfactory grade and cannot continue with the oral part of the exam.

In addition to the exam topics, part of the exam is answering questions that aim at assessing the general knowledge of the student.

Examiners

• Pál Szilárd

Instructor / tutor of practices and seminars

• Kása Péter
• Pál Szilárd