A sponsor may elect to add a Tissue Dissection study to determine tissue concentration of radiolabeled drug in a nonclinical in vivo ADME study when distribution data is needed for a specific tissue or organ.
Tissue Dissection Studies to Evaluate In Vivo Distribution
Our Approach to Tissue Dissection to Assess Localized Drug Concentration
Tissue Dissection is one of our specialized in vivo ADME studies performed by our sister lab in Tokai, Japan. This study can tell a drug developer the drug concentration in tissues and organs, as part of a distribution study in the relevat animal model.
The Drug Development Solutions Center has accumulated over 50 years’ experience performing radioisotope (RI) experimentation, synthesis, and purity checks for pharmaceutical companies as the leading in vivo ADME CRO in Japan. The facilities are AAALAC-accredited to meet compliance with ethical requirements upheld by FDA, EMA, and PMDA for all animal studies– find out more about the Drug Development Solutions Center’s radiolabeled compound synthesis and in vivo ADME capabilities.
In vivo time-course distribution of a drug and its metabolites in various tissues can be determined by quantifying radiolabeled drug in dissected target tissues from treated animals of a clinically relevant species at several time points, out to complete excretion.
Persistency and plasma protein binding ratio are also analyzed to complement drug concentration data. In the case of considerable persistence of tissue radioactivity, the chemical form of residual radioactivity is analyzed.
Tissue Dissection Study Capabilities
|HUMAN CYP MARKERS||UGT, MAO AND OTHERS||ANIMAL P450S||DRUG TRANSPORT||Tissue Options|
|1′ -Hydroxy midazolam (3A4)|
6β-Hydroxy testosterone (3A4)
Oxidized nifedipine (3A4)
ortho-Hydroxy atorvastatin (3A4)
Hydroxy bufuralol (2D6)
7-Hydroxy coumarin (2A6)
Hydroxy bupropion (2B6)
8-Hydroxy efavirenz (2B6)
6α-Hydroxy paclitaxel (2C8)
N-Desethyl amodiaquine (2C8)
4′ -Hydroxy diclofenac (2C9)
4-Hydroxy tolbutamide (2C9)
4′ -Hydroxy mephenytoin (2C19)
6-Hydroxy chlorzoxazone (2E1)
Hydroxy ebastine (2J2)
12-Hydroxy lauric acid (4A11)
|Estradiol-3-β-D- glucuronide (UGT1A1)|
Chenodeoxycholic acid glucuronide (UGT1A3)
Trifluoperazine glucuronide (UGT1A4)
Naphthol glucuronide (UGT1A6)
Propofol glucuronide (UGT1A9)
Testosterone-β-D glucuronide (UGT2B17)
4-Methylumbelliferyl glucuronide (UGTs)
5-Hydroxy tryptophol (MAO-A)
Dimethylamino benzaldehyde (MAO-B)
Vanillic acid (Aldehyde Oxidase)
Phthalazone (Aldehyde Oxidase)
5-Aceominosalicylic acid (NAT-1)
|Rat Hydroxy- testosterone (2α, 6β, 7α, 16β)|
Dog Hydroxy testosterone
Mouse Hydroxy- testosterone (6β, 15α, 16β)
Monkey Hydroxy-testosterone (2β, 6β, 16α, 16β)
Mandibular gland, Fat
Mandibular lymph node
*Can be fractionated
Other tissue types may be available upon request.