BIOAVAILABILITY and BIOEQUIVALENCE
APRIL
15 - 16, 2004 Hotel Princess Ýstanbul
Seminer Sunumlarý
BA/BY Studies as a Surrogate for Clinical Investigations
Rettig, APV
Biopharmaceutical Classification System (BCS) – Dissolution
Testing as a Surrogate for BE Studies Barends, APV
Dissolution Testing as a Surrogate for Bio - Studies - The
BCS Concept Krämer, APV
USP
Chapter 1092
Quality of Clinical Trial Material to be Tested in Man Krämer, APV
Annex 13 -Manufacture
of investigational medicinal products
Design of Typical Bioavailability and Bioequivalence
Studies Rettig, APV
EMEA – NIG 1401/98
Physiological Meaningful Dissolution Testing
? Krämer, APV
Summary of Day One Warm Up Krämer, APV
Pharmacokinetic Analysis and Biometric Evaluation Rettig, APV
616fnl Stat-FDA
Design
and Validation of Bioanalytical Test Methods for
BA/BE Studies Krämer, APV
FDA bioanalytical method validation may2001_4252fnl
Special Aspects for BA/BE Testing Rettig, APV
EMEA Nfg
604/96
EMEA Nfg 280/96
EMEA Nfg
240/95
187503 Line Extension to MR
General Discussion on BE/BE Testing and/or Data Processing
Demonstrations Rettig, APV - Krämer,
APV
Demo f2
Comparisons
Role of IVIVC in BA/BE Stratejies
for Product Development Rettig, APV
Application and Experience in the EU of the BCS Concept in
the View of Existing Drug Variations Barends, APV