This message was posted by a user wishing to remain anonymous
Dear RA community:
We are developing a diabetes product (NCE). However, we are planning to go to Australia before USA. I am trying to determine from the list below, which studies are required to conduct vs. which studies are nice to have. Recognizing that the Australian regulatory review is less intensive then the FDA.
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| PD |
| Cross species GIP activities (cell assay: human, monkey, mouse, rat) |
| In vivo DIO mouse model (PD model) |
| Off target GPCR panel (GLp1, Glucagon receptor etc.) |
| CEREP (Off target) |
| in vitro_Radioligand Competition Binding |
| Safety Pharmacology |
| hERG |
| CNS Rat |
| Cardiovascular and Respiratory Cyno |
| DMPK |
| MetID Hepatocytes |
| MetID liver microsomes |
| Hepatocyte stability (beta-oxidation) |
| Microsomal stability |
| CYP induction assays |
| CYP inhibition assays |
| Beta-oxidation enzyme panel |
| CYP TDI Assay |
| Radiolabeled tissue distribution |
| Radiolabeled metabolism report |
| UGT1A inhibition/substrate |
| Transporter inhibition |
| Transpoter substrate |
| Plasma protein binding (cross species) |
PK
Rat PK |
| Cyno PK |
Tox
Rat Tox DRF (experiment finished) |
| Cyno Tox DRF (experiment finished) |
| Rat GLP tox |
| Cyno GLP Tox |
| Bacterial reverse mutation assay |
| Peripheral blood micronucleus assay |
| In vitro chromosomal aberration assay in Chinese hamsters |
| Phototox assay (Pending on MEC value) |
| MEC values |
| In vitro hemolysis test |
| Active Systemic Anaphylaxis Test_Guinea Pigs |
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