slide1
Download
Skip this Video
Download Presentation
S. Guinot - First Evitherm Industry Forum Meeting – September the 15 th 2003 - Paris

Loading in 2 Seconds...

play fullscreen
1 / 5

S. Guinot - First Evitherm Industry Forum Meeting – September the 15 th 2003 - Paris - PowerPoint PPT Presentation


  • 73 Views
  • Uploaded on

DRUG Development in Pharmacuetical Pre-clinical Research. Pre-clinical research and development objective :. To obtain a molecule that is active in animals, ready to be tested in humans witn minimum risk and maximum chances of success. Pharmaceutical sciences :. Preformulation

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about ' S. Guinot - First Evitherm Industry Forum Meeting – September the 15 th 2003 - Paris' - knoton


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1

DRUG Development in Pharmacuetical

Pre-clinical Research

  • Pre-clinical research and development objective :
  • To obtain a molecule that is active in animals,
  • ready to be tested in humans witn minimum risk and
  • maximum chances of success.
  • Pharmaceutical sciences :
  • Preformulation
  • Clinical Development
  • Pharmaceutical Development
  • Regulatory Affairs

S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris

slide2

Pharmaceutical Sciences – Preformulation

  • Role : establish the physicochemical and biopharmaceutical profile of pharmaceutical compounds to help selection of candidates for clinical administration.
  • Disciplines :
  • Chemical analysis : solubility and chemical stability
  • Physical analysis : solid state profile and stability, polymorphism
  • Biopharmacy : physico-chemistry and formulation for in vivo
  • administration

S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris

slide3

Purification

Crystallisation

Formulation

Storage

Synthesis

Administration

Storage

Distribution

Physico-chimistry

in the body

Preformulation – Physical analysis

*

* Physical form

of the drug

is

CRUCIAL !

*

*

S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris

slide4

Physical form of the drug is CRUCIAL !

  • to guarantee a good bioavailability
  • to ensure physical stability during formulation, storage and processing
  • Most stable and appropriate crystalline form wanted
  • Solid state parameters needed :
  • crystallinity *
  • « physical » purity *
  • melting temperature *
  • decomposition temperature *
  • hygroscopicity
  • shape and particle size distribution
  • texture
  • polymorphic form in general *

* Can be obtained by

thermal methods

S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris

slide5

Thermal info overall needs in a pharmaceutical sciences context

  • Info (any kind) about thermal analysis and microcalorimetry
  • equipment suppliers
  • Basic advices for equipment maintenance and calibration
  • Thermal database for APIs and excipients
  • Basic technical and academic knowledge concerning thermal methods
  • (DSC, MDSC, TGA, Hres TGA, coupling…)
  • Support for complex thermal methods choice of parameters
  • (MDSC, HiRes TGA…)
  • Contacts with experts in the field
  • Items and/or web links for thermal analysis and calorimetry trainings, workshops, conferences, outsourcing, consultancy, jobs, people…
  • Thermal bibliography sorted for specific field of interest
  • (food, pharmaceuticals-polymorphism, cosmetics…)
  • Support for complex data interpretation

Low

priority

High

priority

S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris

ad