| | |
Supplied material
|
Administered material
|
Material
in vivo
/
in vitro
|
|
Size distribution (primary particles)
|
E (Combine with agglomeration state)
|
E
|
D
|
D
|
|
Shape
|
E
|
E
|
O
|
O
|
|
Surface area
|
D
|
E
|
D
|
O
|
|
Composition
|
E
|
E
|
O
|
O
|
|
Surface chemistry
|
D
|
E
|
D
|
D/O
|
|
Surface contamination
|
D
|
N
|
D
|
N
|
|
Surface charge – suspension/solution
|
O
|
E
|
E
|
O
|
|
Surface charge – powder (use bio fluid surrogate)
|
O
|
E
|
N
|
O
|
|
Crystal structure
|
O
|
E
|
O
|
O
|
|
Particle physicochemical structure
|
E
|
E
|
D
|
D
|
|
Agglomeration state
|
E
|
N
|
E
|
D
|
|
Porosity
|
D
|
D
|
N
|
N
|
|
Method of production
|
E
|
E
|
--
|
--
|
|
Preparation process
|
--
|
--
|
E
|
--
|
|
Heterogeneity
|
D
|
E
|
E
|
D
|
|
Prior storage of material
|
E
|
E
|
E
|
--
|
|
Concentration
|
E
|
--
|
E
|
D
|
