FDA and EMA Compliance
SOLVO Biotechnology provides all major drug transporter assays that comply with FDA and EMA Guidelines and with the recommendations of the International Transporter Consortium (ITC).
Please find below the relevant regulatory documents related to drug transporter studies released up to present:
Regulatory Guidelines
- FDA Guidance 2006 (2006 FDA Draft Guidance) Download
- EMA Guideline 2010 EMA Draft Guideline on the Investigation of Drug Interactions
Related Recommendations
- Recommendations by pharma, academic and regulatory experts (International Transporter Consortium, ITC) are introduced in Nature Reviews Drug Discovery (2010) Volume 9 /March: 215:236
- • FDA Advisory Committee Approved Recommendation for Routine Transporter DDI Assessment for New Drugs - FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology voted to recommend NCE’s to be assessed for transporter mediated drug-interactions for the seven clinically relevant transporters in the ITC Transporter White Paper. Transcript from the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology Meeting
Transporters in focus in the regulatory documents
Transporters in focus in the regulatory documents
| FDA Guidance 2006 | ITC recommendation | EMA Guidelines 2010 | |
| P-gp/MDR1 | • | • | • |
| BCRP | • | • | |
| BSEP | • | ||
| OATP1B1 | • | • | |
| OATP1B3 | • | • | |
| OCT1 | • | ||
| OCT2 | • | • | |
| OAT1 | • | • | |
| OAT3 | • | • |
List of the FDA- and EMA-recommended drug transporter services and reagents suitable for both substrate and inhibitor assessment studies and available at SOLVO Biotechnology
P-gp / MDR1
Why is P-gp important?
P-gp drug efflux transporter is present in all the pharmacological barriers that influence the ADMETox properties of drugs.
Drugs that are substrates or inhibitors of P-gp may participate in drug-drug or drug-nutrient interactions, leading to a modified bioavailability of the drug and to serious side effects such as morbidity in case of drugs with narrow therapeutic index.
What are the main characteristics of SOLVO’s FDA-compliant P-gp services?
- Studies can be conducted using human Caco-2, or MDCKII-MDR1 cell lines according to your request
- The general protocol applies two P-gp inhibitors in the Caco-2 assay recommended by the FDA: Verapamil and Ketoconazole
- It can identify P-gp substrate and inhibitory properties of your drug or drug candidate
- It can provide IC50 data for the inhibition of digoxin transport
- It is a flexible design for optimal cost and quick turn-around time
- Clear and consistent flow-chart with decision points describes SOLVO’s FDA-compliant P-gp studies
You can also run your FDA/EMA compliant P-gp study in-house using SOLVO’s PreadyPortTM-MDR1 product line.
BCRP
MDCKII-BCRP monolayer assays: to investigate specific transporter interactions for medium to high permeability test articles.
Details
BSEP
BSEP vesicular transport services and membrane preparations: high-throughput vesicular transport assay to identify compounds that interact with human BSEP.
Details
OATP1B1
In vitro cellular assay: available as a service using stably transfected CHO-OATP1B1 cell line and 3H-Estrone-3-Sulfate as probe substrate.
PREDICELLTM product line: ready-to-use pre-plated uptake transporter expressing cells for in-house studies.
Details
OATP1B3
In vitro cellular assay: available as a service using stably transfected CHO-OATP1B3 cell line and Fluo-3 as probe substrate.
PREDICELLTM product line: ready-to-use pre-plated uptake transporter expressing cells for in-house studies.
Details
OCT1
In vitro cellular assay: available as a service using stably transfected CHO-OCT1 cell line and 14C-Tetraethylammonium-chloride (TEA) as probe substrate.
PREDICELLTM product line: ready-to-use pre-plated uptake transporter expressing cells for in-house studies.
Details
OCT2
In vitro cellular assay: available as a service using stably transfected CHO-OCT2 cell line and 14C-Tetraethylammonium-chloride (TEA) or 14C-Metformin as probe substrate.
PREDICELLTM product line: ready-to-use pre-plated uptake transporter expressing cells for in-house studies.
Details
OAT1
In vitro cellular assay: available as a service using stably transfected CHO-OAT1 cell line and 3H-p-Aminohippuric acid (PAH) as probe substrate.
PREDICELLTM product line: ready-to-use pre-plated uptake transporter expressing cells for in-house studies.
Details
OAT3
In vitro cellular assay: available as a service using stably transfected HEK293-OAT3 cell line and 3H-p-Aminohippuric acid (PAH) as probe substrate.
PREDICELLTM product line: ready-to-use pre-plated uptake transporter expressing cells for in-house studies.
Details
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BCRP
BSEP
OATP1B3
OCT1
OATP1B1
OCT2
OAT1
OAT3
