ANALYTICAL METHODS FOR THE PHARMACEUTICAL INDUSTRY

The course aims to provide the student with some specialized notions in the field of the various analytical investigations necessary to comply with the regulatory activities governing the industrial production of a drug.

Frontal lessons

Preliminary and functional investigations for the production of a pharmaceutical preparation

Formulation studies

Control of the stability of the chosen formulation

Studies of pharmacokinetics and / or pharmacodynamics on the formulation

Preparation of the drug dossier

Controls necessary for the actual production phase

Control of raw materials

Checks during some phasesof the production process, and at the end as well

Checks on the pharmaceutical product before placing it on the market

Quality control of the pharmaceutical product

Pharmaceutical product stability checks

Quality in the Pharmaceutical Industry: from Development to Production

The pharmaceutical research & development process

The pharmaceutical profiling

Regulatory aspects: ICH guidelines (ICH-Q8, ICH-Q9, ICH-Q10)

Quality by design (QbD)

Critical quality attributes (CQA)

Studies of stability of a pharmaceutical product

Formal stability studies; the stress test.

From analytical techniques to analytical methods

The most common laboratory and instrumental analytical techniques

Identification of the analytical need

The choice of the appropriate analytical technique

Development of the analytical method

Validation of the analytical method

Specificity; linearity; range; detection limit; quantification limit; accuracy; precision; robustness.

Statistical treatment of results and evaluation of their significance; the T test and the Two-One-Side-Test (TOST).

Some examples of "case studies"

Qualitative and quantitative determination of antazolin and tetrizoline in ophthalmic preparations.

Example of determination of the purity of a raw material (octyl-dimethyl-p-amino benzoic acid).

Analysis of residual solvents in pharmaceutical substances, excipients and final products.

The application of HILIC chromatography for drugs with basic functional groups.

The application of Sequential Injection Analysis to analyze complex mixtures of polar and non polar drugs.

Seminar on: Pre-industrial development of a new pharmaceutical active ingredient.

- Behnam Davani, Pharmaceutical Analysis for Small Molecules

Print ISBN:9781119121114|Online ISBN:9781119425021; © 2017 John Wiley & Sons, Inc.

- Joachim Ermer and John H. McB. Miller, Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Print ISBN:9783527312559 |Online ISBN:9783527604685; © 2005 Wiley‐VCH Verlag GmbH & Co. KGaA