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