Advanced Pharmaceuticals: From Calculation to Analysis

Adatok

A Tantárgybejelentőben megadott hivatalos adatok az alábbi tanévre: 2024-2025

Tematika

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.

Előadások

• 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

Gyakorlatok

Szemináriumok

A tananyag elsajátításához szükséges segédanyagok

Kötelező irodalom

Saját oktatási anyag

Jegyzet

Class notes and materials issued during the semester.

Ajánlott irodalom

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

A félév elfogadásának feltételei

A maximum of 25 % absence allowed

Félévközi ellenőrzések

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

Távolmaradás pótlásának lehetőségei

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.

Vizsgakérdések

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

Vizsgáztatók

• Ámanné Takácsi-Nagy Anna Erzsébet
• Das Sourav

Gyakorlatok, szemináriumok oktatói

• Ámanné Takácsi-Nagy Anna Erzsébet
• Das Sourav