EUFEPS Decennial
Anniversary Conference on
Optimising Drug Development
Rational Design of
Drug Materials and Drug Delivery Systems
September 20-21 •
2001
European Parliament,
entrance Avenue Robert Schuman
Bâtiment Winston Churchill (WIC) • Strasbourg •
France
A unique discussion
forum for scientists from the pharmaceutical industry, regulatory
agencies and academic institutions.
Scope
and aim
Pharmaceutical and Biopharmaceutical Performances of New Chemical
Entities (NCE) are largely dependent on the formulations and/or
drug delivery systems available for their study. This Conference
will focus on how to select and design the drug material, the
formulations and/or the drug delivery systems that will be needed
for NCE Developability Assessment (Bioavailability, Manufacturability,
Stability), as well as on how to conduct the studies from lead
identification to First in Man. The questions raised include:
-
What
complexities in salt screening and salt selection should be
considered?
-
How
and when to assess the biopharmaceutical performance of solid
state drug material?
-
What
complexities in polymorph/solid state variations have to be
considered?
-
Can
polymorph/solid state variations be predicted in silico?
-
How
to design relevant preclinical formulations (standard versus
non standard) and when?
-
What
are the decision points for initiating in vivo bioavailability
assessments, with regard to drug delivery system opportunities?
-
What
complexities in the design of drug delivery systems should be
explored?
-
How
could drug delivery systems solve NCE solubility limitations?
-
How
could drug delivery systems modify NCE chemical degradation?
-
How
could drug delivery systems modify NCE membrane transport as
well as enzyme degradation?
-
Will
clinicians agree on what is important? With regard to dose limitations?
PK profile?
-
How
to translate solid state characterisation data into drug substance
specifications?
-
What
complexities to consider before First in Man?
Scientific Programme
Committee
Co-Chairs: Per Artursson; Henning Kristensen; Michel Veillard
Vice-Chairs: Gordon Amidon; Ubaldo Conte; Ajaz Hussain;
Franck Leveiller
Additional Members: Agnès Artiges; Michel Bauer;
Ole J. Bjerrum; Henning H. Blume; Michael Bowker; Graham Buckton;
Dominique Duchêne; Henk de Jong; Malcolm Rowland; Francis
Schuber; Jörgen Vessman
Organising Committee
Chair: Michael Bowker
Additional Members: Hans H. Linden; Maria Norrlander
Call for Abstracts
Scientific contributions relating to any aspect of drug material
and drug delivery will be considered for poster presentation.
Abstracts should be submitted to the EUFEPS Secretariat, both
as an email attachment and as a hard copy, before July 15, 2001.
Forward material to the Secretariat by email; conferences@eufeps.org
or by fax +46 8 4113217.
Click for editorial
instructions.
Language
English will be the language of the Conference. No simultaneous
translation will be provided.
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