Analytical Development in Generic PharmaThe Place and the Role of Analytical Support for Development of Generic Pharmaceutical Products

Conducted by: Dr. Vladimir Ioffe
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Classroom
Date:  25 November, 2020
Course location: Kfar Maccabiah, Ramat Gan
Duration: 1-Day Course
Hours: 09:00 - 17:00
Credits: 1
Course Language: עברית

Course price: 1,850 NIS + VAT
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Issues to be covered

The first part of the seminar describes the role of analytical support in pharmaceutical development, especially in development of formulations for generic pharmaceutical products.

The main emphasis will be on the special role of pharmaceutical analysis in assessing information on the quality of pharmaceutical products. The correct choice of parameters to be measured will be discussed.
Special attention will be given to building interdisciplinary communication and establishing a common language.

The key aims of drug analysis – quality and safety – will be reviewed, as well as types of analytical tasks with respect to the requirements of regulatory authorities.

The second part of the seminar will be dedicated to the role of pharmaceutical analysis in assessing information on the quality of pharmaceutical products. Meaning and importance of selectivity and specificity in pharmaceutical analysis will be discussed. Introduction of separation methods (chromatography, etc.) into the pharmaceutical analysis will be explained and justified.

The following issues will be covered:

  • Overview of separation methods
  • Overview of detection techniques
  • Influence of mobile phase composition, pH, temperature, column type, etc. on the chromatographic performance
  • Comparison of isocratic and gradient chromatography
  • Introduction of the definition “stability indicating method”
  • Confirmation stability indicating capability of analytical methods
  • Overview of chiral (enantioselective) methods

The third part of the seminar will be dedicated to assessment of drug performance characteristics, especially, dissolution testing. Special emphasis will be placed on the fact that it is a quality control tool and an aid to formulation development, and may also be indicative of changes in stability.

The following issues will be covered:

  • Discussion on bioavailability, bioequivalence and in-vitro / in-vivo correlation
  • Overview of dissolution techniques, their differences and fields of application
  • Factors influencing dissolution rate

The last part of the seminar will deal with some auxiliary tests relevant for pharmaceutical development.

The following issues will be covered:

  • Particle size and shape analysis
  • Polymorphism studies
  • Influence of packaging materials on the quality of pharmaceutical products, especially, analysis of leachables and extractables.

Who should attend

  • Industrial pharmaceutical scientists working in R&D laboratories or in QC/QA
  • University students and post-graduates in the field of pharmaceutical development.

Benefits to the Participants

Participants will learn about:

  • The role of analytical support in pharmaceutical development
  • The role of pharmaceutical analysis in assessing information on the quality of pharmaceutical products
  • The role of pharmaceutical analysis in assessing information on the quality of pharmaceutical products
  • How to assess drug performance characteristics
  • Auxiliary tests relevant for pharmaceutical development

& – above all –
Building interdisciplinary communication and establishing a common language between the R&D and the analytical staff

About The Lecturer

Vladimir Ioffe
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