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The Andromeda System
The assessment of bioequivalence (BE) is based on the fundamental
assumption that the two drug products, brand name and generic,
are equivalent in the rate and extent of drug absorption when
administered at the same molar dose of the therapeutic ingredient
under similar experimental conditions. The methods used to document
BE include, in descending order of preference, pharmacokinetic (PK),
pharmacodynamic (PD), clinical and in vitro studies. Equivalence
is indicated when key pharmacokinetic parameters used to establish
rate and extent of the test and reference product fall within preset
confi dence interval.
In general BE frequently relies on PK measures such as AUC, and
Cmax that are refl ective of systemic exposure. However, establishing
BE for certain types of drug products is challenging, simple PK measures
are not suffi cient, and in some cases not accessible. Different BE
criteria need to be considered for drug products that are:
• Highly variable
• Orally administered non-absorbed
• Administered by inhalation
• Topically administered
• Orally administered Extended Release CNS dosage forms
In these cases either (i) a partial replicate study design (ii) a
comparative clinical trial (iii) a PD measure (skin blanching for
glucocorticoids) (iv) a comparative in vitro drug release (for topical
antifungals) or (v) an additional partial AUC (for ER CNS drugs) is
recommended.
Spiral Galaxy
An enormous spiral galaxy much like the
Milky Way can be seen in the distance.
Open Star Cluster
This open cluster is confined to
the galactic plane.
They contain
a collection of young stars, up to
a
few tens of millions of years old.