Search results with tag "Bioavailability studies"

Guideline o the Investigation of Bioequivalence

www.ema.europa.eu

studies, except pilot studies for which study report synopses (in accordance with ICH E3) are sufficient. Full study reports for pilot studies should be available upon request. Study report synopses for bioequivalence or comparative bioavailability studies conducted during formulation development should also be included in Module 2.7.

Studies, Investigation, Bioequivalence, Bioavailability, Bioavailability studies, The investigation of bioequivalence

ASEAN GUIDELINE FOR THE CONDUCT OF BIOEQUIVALENCE …

asean.org

criteria under which bioavailability studies need not be required (either waiver for additional strength, see section 3.1.6, a specific type of formulation, see Appendix II or BCS based Biowaiver, see Appendix III). Specific recommendations regarding bioequivalence studies for other products, eg.

Studies, Bioavailability, Bioavailability studies

Data exclusivity, market protection, orphan and paediatric ...

www.ema.europa.eu

bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in

Data, Protection, Studies, Market, Bioequivalence, Bioavailability, Orphans, Exclusivity, Bioavailability studies, Data exclusivity, Market protection, Orphan and

BIOAVAILABILITY OF METALS INTRODUCTION

pubs.usgs.gov

these metal fluxes must be considered in overall metal bioavailability studies. Bioaccumulation of metals by biota in surface water and by plants and animals in terrestrial environments can adversely affect humans. In surface and ground water, sediment and air, bioavailability is a complex function of many factors including total concentration