Tantargy

Data

Official data in SubjectManager for the following academic year: 2024-2025

Course director

Das Sourav
assistant lecturer,
Institute of Pharmaceutical Technology and Biopharmacy
sourav.das@pte.hu

Number of hours/semester

Lectures: 28 hours

Practices: 0 hours

Seminars: 0 hours

Total of: 28 hours

Subject data

Code of subject: OPF-APC-T
2 Credit
Pharmacy
Optional module
spring

Prerequisites:

OPG-C4E-T parallel

Course headcount limitations

min. 5 people – max. 30 people

Topic

This course provides a comprehensive understanding of the fundamental principles of technical calculations and statistical analysis in pharmaceutical sciences. Students will learn the importance of accurate measurement techniques in pharmaceutical manufacturing, quality control, and regulatory compliance. Through a combination of theoretical concepts, topics covered include measurement uncertainty, calibration methods, statistical methods for data analysis, and quality assurance principles. Emphasis will be placed on developing critical thinking skills to effectively interpret and apply metrological and statistical principles in pharmaceutical research and industrial practice. Additionally, the course will focus on refining students' abilities to engage in TDK-related research, preparing them for further exploration and advancement in the field of pharmaceutical sciences.

Lectures

1.
Introduction
- Das Sourav
2.
Introduction
- Das Sourav
3.
Principles of measurement uncertainty
- Das Sourav
4.
Principles of measurement uncertainty
- Das Sourav
5.
Calibration techniques in pharmaceutical sciences
- Das Sourav
6.
Calibration techniques in pharmaceutical sciences
- Das Sourav
7.
Statistical methods for data analysis
- Das Sourav
8.
Statistical methods for data analysis
- Das Sourav
9.
Quality control in pharmaceutical manufacturing
- Das Sourav
10.
Quality control in pharmaceutical manufacturing
- Das Sourav
11.
Analytical instruments and equipment
- Ámanné Takácsi-Nagy Anna Erzsébet
12.
Analytical instruments and equipment
- Ámanné Takácsi-Nagy Anna Erzsébet
13.
Written exam I
- Das Sourav
14.
Written exam I
- Das Sourav
15.
Design of experiments (DOE) in pharmaceutical research
- Das Sourav
16.
Design of experiments (DOE) in pharmaceutical research
- Das Sourav
17.
Good manufacturing practices (GMP) compliance
- Ámanné Takácsi-Nagy Anna Erzsébet
18.
Good manufacturing practices (GMP) compliance
- Ámanné Takácsi-Nagy Anna Erzsébet
19.
Case studies
- Das Sourav
20.
Case studies
- Das Sourav
21.
Statistical process control (SPC) in pharmaceutical production
- Das Sourav
22.
Statistical process control (SPC) in pharmaceutical production
- Das Sourav
23.
Validation and verification of measurement systems
- Das Sourav
24.
Validation and verification of measurement systems
- Das Sourav
25.
Applications of calculations and statistical analysis in regulatory compliance
- Das Sourav
26.
Applications of calculations and statistical analysis in regulatory compliance
- Das Sourav
27.
Written exam II
- Das Sourav
28.
Written exam II
- Das Sourav

Practices

Seminars

Reading material

Obligatory literature

Literature developed by the Department

Notes

Class notes and materials issued during the semester.

Recommended literature

Pharmaceutical Formulation: The Science and Technology of Dosage Forms, Geoffrey D Tovey, ISBN: 978178801443

European Pharmacopoeia (Ph. Eur.)

https://www.eurachem.org/index.php/publications/guides

Conditions for acceptance of the semester

A maximum of 25 % absence allowed

Mid-term exams

Students have to write an end-of-semester assessment from the lecture at an acceptable level of 60%.

Making up for missed classes

In case absences exceed 25% of total class time, the course will be regarded as uncompleted. There is no opportunity to make up missed classes.

Exam topics/questions