Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? R. L. WilliamsW. AdamsFDA Biopharmaceutics Coordinating Committee OriginalPaper Pages: 7 - 12
The basis for individual bioequivalence R. L. WilliamsR. N. PatnaikFDA Population and Individual Bioequivalence Working Group OriginalPaper Pages: 13 - 17
Dissolution and in vivo evidence of differences in reference products: impact on development of generic drugs Michael SpinoYu Chung TsangRadu Pop OriginalPaper Pages: 18 - 24
Guidances related to bioavailability and bioequivalence: European industry perspective Gertrud AhrBarbara VoithJochen Kuhlmann OriginalPaper Pages: 25 - 27
Differences in reference products: dissolution and in vivo evidence Iain J. McGilveray OriginalPaper Pages: 32 - 35
Current status of the international comparator (reference) product system Juhana E. Idänpään-Heikkilä OriginalPaper Pages: 36 - 37
Equivalence concepts in clinical trials V. W. SteinijansM. NeuhäuserF. Bretz OriginalPaper Pages: 38 - 40
Biopharmaceutical characterisation of herbal medicinal products: are in vivo studies necessary? H. H. BlumeB. S. Schug OriginalPaper Pages: 41 - 48
Pharmacometrics: modelling and simulation tools to improve decision making in clinical drug development R. GieschkeJ-L. Steimer OriginalPaper Pages: 49 - 58
International reference product — innovator industry’s perspective Martin Siewert BriefCommunication Pages: 61 - 62
Realities and implementation — report of the International Workshop on IBE, Montreal, Canada, August 1999 K. K. MidhaM. J. RawsonJ. W. Hubbard Announcement Pages: 63 - 63
Bioequivalence-quality parameter or therapeutic surrogate Lennart K. Paalzow BriefCommunication Pages: 64 - 64
Dissolution studies as surrogate for bioequivalence Gordon L. Amidon BriefCommunication Pages: 65 - 65
CPMP ‘Note for Guidance’ on bioavailability and bioequivalence Jóse A. Guimarães Morais BriefCommunication Pages: 66 - 67
Permeability, metabolism, transporters and systemic exposure Leslie Z. Benet BriefCommunication Pages: 68 - 68
Clinical consequences of ‘failed’ bioequivalence studies Lawrence J. LeskoDennis BashawPeter K. Honig BriefCommunication Pages: 69 - 69
Pharmacokinetic evaluation of controlled release dosage forms Avraham Yacobi BriefCommunication Pages: 70 - 70
