Analytical Development in Generic Pharma

The Place and the Role of Analytical Support for Development of Generic Pharmaceutical Products
Lecturer: Dr. Vladimir Ioffe

Date: 21 October 2018
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 1 - Day Course
Hours: 09:00 – 17:00
Price: 1,850 NIS + VAT
Credit Points: 1
SKU: 18403
Course Language: Hebrew
About the Course
TBA
Who should attend
TBA
Analytical Development in Generic Pharma
Benefits to the Participants
TBA
Contact us
  • Full Name
  • Email
  • Phone
  • Notes
  • Send
Issues to be covered
 
What should a pharmaceutical scientist think about when he requires analytical service?
This question and more will be addressed in this 1 day course.

A comprehensive list of recommended literature, relevant for pharmaceutical analysis and analytical development, will be provided as a valuable supplement to the seminar.
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
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.
About the Speaker
Vladimir Ioffe, Ph.D: Team Leader, Analytical Development, Global Innovative R&D Division, Teva Pharmaceutical Industries, Ltd.
Principal fields of interest:
  • Innovative development of HPLC methods
  • Upgrade of analytical HPLC procedures to bioanalytical
  • RP HPLC of polar lipids and new biologically active small molecules
  • Combination of various detection techniques within one HPLC method
  • Simultaneous development of auxiliary to HPLC analytical methods (planar chromatography, spectral and thermal methods, mass-spectrometry, etc.)
About The Lecturer
More Courses from this Category
Learning from us