Drukuj sylabusApplication of selected analytical methods in drug product quality control
Informacje ogólne
| Kod przedmiotu: | 1700-OG-EN-APPSELN |
| Kod Erasmus / ISCED: |
(brak danych)
/
(0916) Farmacja
|
| Nazwa przedmiotu: | Application of selected analytical methods in drug product quality control |
| Jednostka: | Katedra Chemii Nieorganicznej i Analitycznej |
| Grupy: | |
| Punkty ECTS i inne: |
2.00
|
| Język prowadzenia: | angielski |
| Wymagania wstępne: | (tylko po angielsku) A basic knowledge of pharmaceutical sciences and instrumental analytical methods is needed to participate in laboratory. |
| Całkowity nakład pracy studenta: | (tylko po angielsku) Contact hours with teacher: - participation in laboratory - 30 hrs - consultations- 2 hrs The workload related to the activities requiring the direct participation of academic teachers is 32 hrs, which corresponds to 1.28 ECTS points. Self-study hours: - preparation for laboratory - 7 hrs - reading literature- 4 hrs - preparation for test- 7 hrs The total workload related to the self-study hours is 18 hours, which corresponds to 0.72 ECTS point. Altogether: 50 hrs (2 ECTS) |
| Efekty uczenia się - wiedza: | (tylko po angielsku) Student: W1: has basic knowledge of selected analytical methods (e.g. UV-Vis spectroscopy, high performance liquid chromatography) – K_B.W13 W2: knows basic definitions and scientific terminology connected with selected analytical methods used in pharmaceutical quality control- K_B.W13 W3: possesses knowledge on sample preparation for pharmaceutical analysis - K_B.W14 W4: is familiar with the quality control of pharmaceutical raw materials and drug products - K_B.W14 W5: is acquainted with the development and optimization of selected analytical methods used in drug product quality control - K_B.W14 |
| Efekty uczenia się - umiejętności: | (tylko po angielsku) Student: U1: has the ability to select and develop the appropriate analytical method for drug product quality control – K_B.U7 U2: is capable of the assessment the drug product quality - K_C.U2 U3: has basic skills in sample preparation for pharmaceutical analysis - K_B.U8 U4: can define basic terminology connected with pharmaceutical quality control - K_B.U7 U5: has basic skills in data analysis and interpretation as well as drawing conclusions on drug product quality - K_C.U19 |
| Efekty uczenia się - kompetencje społeczne: | (tylko po angielsku) Student: K1: understands the significance of drug product quality control – K_B.K1 K2: understands the importance of selection the appropriate analytical method for the reliable evaluation of drug product quality - K_B.K1 |
| Metody dydaktyczne: | (tylko po angielsku) Expository teaching methods: - practical analysis in labs |
| Skrócony opis: |
(tylko po angielsku) The subject includes 30 hours of labs. The laboratory is focused on instrumental analytical methods used in pharmaceutical quality control. |
| Pełny opis: |
(tylko po angielsku) The student will be involved in the pharmaceutical quality evaluation of selected drug dosage forms as well as pharmaceutical raw materials. During lab classes the student will carry out experimental research studies in the field of pharmaceutical analysis and drug product quality control. The student will gather knowledge and practical skills in the selection and development of the appropriate analytical methods (e.g. UV-Vis spectroscopy, high performance liquid chromatography) for the evaluation of drug product quality. The student will gather skills in data analysis and interpretation as well as drawing conclusions on drug product quality. |
| Literatura: |
(tylko po angielsku) Scientific articles (indicated by the lecturer) published in international journals such as: European Journal of Pharmaceutical Sciences, Drug Development and Industrial Pharmacy, Journal of Pharmaceutical and Biomedical Analysis, Pharmaceutics. Pharmaceuticals. Articles available online: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/quality-guidelines http://biblio.cm.umk.pl/index.php?id=czytelnia_online |
| Metody i kryteria oceniania: |
(tylko po angielsku) Assessment methods: - test (W1-W5, U1-U5) The appropriate number of points from the final test is required. Assessment criteria: fail- 0-59% satisfactory- 60-67% satisfactory plus- 68-75% good – 76-83% good plus- 84-90% very good- 91-100% |
| Praktyki zawodowe: |
(tylko po angielsku) Not applicable |
Zajęcia w cyklu "Semestr letni 2021/22" (zakończony)
| Okres: | 2022-02-21 - 2022-09-30 |
 
PN WT ŚR CZ PT |
| Typ zajęć: |
Laboratorium, 30 godzin
|
|
| Koordynatorzy: | Joanna Ronowicz-Pilarczyk | |
| Prowadzący grup: | (brak danych) | |
| Lista studentów: | (nie masz dostępu) | |
| Zaliczenie: |
Przedmiot -
Zaliczenie na ocenę
Laboratorium - Zaliczenie na ocenę |
|
| Skrócony opis: |
(tylko po angielsku) The subject includes 30 hours of labs. The laboratory is focused on instrumental analytical methods used in pharmaceutical quality control. |
|
| Pełny opis: |
(tylko po angielsku) The student will be involved in the pharmaceutical quality evaluation of selected drug dosage forms as well as pharmaceutical raw materials. During lab classes the student will carry out experimental research studies in the field of pharmaceutical analysis and drug product quality control. The student will gather knowledge and practical skills in the selection and development of the appropriate analytical methods (e.g. UV-Vis spectroscopy, high performance liquid chromatography) for the evaluation of drug product quality. The student will gather skills in data analysis and interpretation as well as drawing conclusions on drug product quality. |
|
| Literatura: |
(tylko po angielsku) Scientific articles (indicated by the lecturer) published in international journals such as: European Journal of Pharmaceutical Sciences, Drug Development and Industrial Pharmacy, Journal of Pharmaceutical and Biomedical Analysis, Pharmaceutics. Pharmaceuticals. Articles available online: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/quality-guidelines http://biblio.cm.umk.pl/index.php?id=czytelnia_online |
|
Zajęcia w cyklu "Semestr letni 2022/23" (zakończony)
| Okres: | 2023-02-20 - 2023-09-30 |
PN WT ŚR CZ PT |
| Typ zajęć: |
Laboratorium, 30 godzin, 6 miejsc
|
|
| Koordynatorzy: | Joanna Ronowicz-Pilarczyk | |
| Prowadzący grup: | (brak danych) | |
| Lista studentów: | (nie masz dostępu) | |
| Zaliczenie: |
Przedmiot -
Zaliczenie na ocenę
Laboratorium - Zaliczenie na ocenę |
|
| Skrócony opis: |
(tylko po angielsku) The subject includes 30 hours of labs. The laboratory is focused on instrumental analytical methods used in pharmaceutical quality control. |
|
| Pełny opis: |
(tylko po angielsku) The student will be involved in the pharmaceutical quality evaluation of selected drug dosage forms as well as pharmaceutical raw materials. During lab classes the student will carry out experimental research studies in the field of pharmaceutical analysis and drug product quality control. The student will gather knowledge and practical skills in the selection and development of the appropriate analytical methods (e.g. UV-Vis spectroscopy, high performance liquid chromatography) for the evaluation of drug product quality. The student will gather skills in data analysis and interpretation as well as drawing conclusions on drug product quality. |
|
| Literatura: |
(tylko po angielsku) Scientific articles (indicated by the lecturer) published in international journals such as: European Journal of Pharmaceutical Sciences, Drug Development and Industrial Pharmacy, Journal of Pharmaceutical and Biomedical Analysis, Pharmaceutics. Pharmaceuticals. Articles available online: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/quality-guidelines http://biblio.cm.umk.pl/index.php?id=czytelnia_online |
|
Właścicielem praw autorskich jest Uniwersytet Mikołaja Kopernika w Toruniu.
