European Journal of Drug Metabolism and Pharmacokinetics

FIP Bio-International ’99

Forward

A. Benakis

Preface

K. K. Midha

Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence?

R. L. Williams, W. Adams, M-L. Chen, D. Hare, A. Hussain, L. Lesko, R. Patnaik, V. Shah

The basis for individual bioequivalence

R. L. Williams, R. N. Patnaik, M-L. Chen

Dissolution and in vivo evidence of differences in reference products: impact on development of generic drugs

Michael Spino, Yu Chung Tsang, Radu Pop

Guidances related to bioavailability and bioequivalence: European industry perspective

Gertrud Ahr, Barbara Voith, Jochen Kuhlmann

Japanese guidance on bioavailability and bioequivalence

Nobuo Aoyagi

Differences in reference products: dissolution and in vivo evidence

Iain J. McGilveray

Current status of the international comparator (reference) product system

Juhana E. Idänpään-Heikkilä

Equivalence concepts in clinical trials

V. W. Steinijans, M. Neuhäuser, F. Bretz

Biopharmaceutical characterisation of herbal medicinal products: are in vivo studies necessary?

H. H. Blume, B. S. Schug

Pharmacometrics: modelling and simulation tools to improve decision making in clinical drug development

R. Gieschke, J-L. Steimer

Summaries of presented papers

International reference product — innovator industry’s perspective

Martin Siewert

Realities and implementation — report of the International Workshop on IBE, Montreal, Canada, August 1999

K. K. Midha, M. J. Rawson, J. W. Hubbard

Bioequivalence-quality parameter or therapeutic surrogate

Lennart K. Paalzow

Dissolution studies as surrogate for bioequivalence

Gordon L. Amidon

CPMP ‘Note for Guidance’ on bioavailability and bioequivalence

Jóse A. Guimarães Morais

Permeability, metabolism, transporters and systemic exposure

Leslie Z. Benet

Clinical consequences of ‘failed’ bioequivalence studies

Lawrence J. Lesko, Dennis Bashaw, Dale P. Conner, Peter K. Honig

Pharmacokinetic evaluation of controlled release dosage forms

Avraham Yacobi

Equivalence in disease states

G. T. Tucker

Equivalence in special populations

Hiroyasu Ogata