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1.
J Microbiol Methods ; 105: 51-3, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25043843

ABSTRACT

We describe a simple device for the aseptic collection of environmental water samples at high spatial resolution to depths of 50m. To demonstrate the utility of this technique we present geochemical and archaeal community data from samples collected throughout the water column of a stratified lake.


Subject(s)
Archaea/isolation & purification , Microbiological Techniques/instrumentation , Microbiological Techniques/methods , Water Microbiology
2.
Eur J Clin Pharmacol ; 67(10): 1007-16, 2011 Oct.
Article in English | MEDLINE | ID: mdl-21494766

ABSTRACT

PURPOSE: The objective of this study was to determine whether the so-called "shift" or "drift" problem might occur when generic anti-epileptic drugs are interchanged, and thus to assess if generic anti-epileptic drugs are interchangeable and can be used in an efficacious and safe way on the basis of their bioequivalence to one and the same reference product. METHODS: The bioequivalence of topiramate and gabapentin generics was evaluated. For proper interstudy comparison, individual exposure data (AUC and C(max)) for each bioequivalence study present in the registration dossier was normalized based on the absolute exposure data of one of two innovators. The exposure-normalized plasma concentration curves of the generic product arms between studies were compared, providing indirect evidence of bioequivalence of the different generics. Additionally, comparisons were made for generic-generic as well as innovator-innovator exchange based on absolute exposure data from individual bioequivalence studies. RESULTS: In almost all cases, estimated 90% confidence intervals of the AUC and C(max) ratios for generic-generic interchange were within the routine 80-125% criterion. When absolute, non-corrected exposure data were used for this interstudy comparison, in a number of cases 90% confidence intervals outside the 80-125% criterion were found upon interchanging generics from two studies. However, a similar pattern of 90% confidence intervals outside the 80-125% criterion was observed for the comparison of innovator arms, despite the fact that the innovator was identical in all studies. CONCLUSION: Our results strongly indicate that the so-called drifting problem upon generic-generic substitution does not result in important differences in exposure upon exchanging topiramate generics or gabapentin generics.


Subject(s)
Amines/pharmacokinetics , Anticonvulsants/pharmacokinetics , Cyclohexanecarboxylic Acids/pharmacokinetics , Drugs, Generic/pharmacokinetics , Fructose/analogs & derivatives , gamma-Aminobutyric Acid/pharmacokinetics , Amines/administration & dosage , Amines/blood , Anticonvulsants/administration & dosage , Anticonvulsants/blood , Area Under Curve , Confidence Intervals , Cyclohexanecarboxylic Acids/administration & dosage , Cyclohexanecarboxylic Acids/blood , Drug Interactions , Drugs, Generic/administration & dosage , Fructose/administration & dosage , Fructose/blood , Fructose/pharmacokinetics , Gabapentin , Humans , Risk Factors , Safety , Therapeutic Equivalency , Topiramate , gamma-Aminobutyric Acid/administration & dosage , gamma-Aminobutyric Acid/blood
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