FDA and EMA Compliance

SOLVO Biotechnology provides all major drug transporter assays that comply with FDA and EMA Guidelines and with the International Transporter Consortium (ITC) recommendations.

Please find below 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FDA Guidance 2006 (2006 FDA Draft Guidance) Download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 (2010 Draft Guideline on the Investigation of Drug Interactions): Download

Additional Documents

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 be assessed for transporter mediated drug-interactions for the seven clinically relevant transporters in the ITC Transporter White Paper.

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		•	•

Features of the FDA- and EMA-recommended and additional drug transporter services and reagents available at SOLVO Biotechnology

P-gp / MDR1

Why is P-gp important?

P-gp drug efflux transporter is present in all pharmacological barriers influencing 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 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 NCE, IND or NDA
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

Ask for a quote: sales@solvo.com

Additional P-gp studies available at SOLVO:

SOLVO has the most comprehensive P-gp technology platform from HT in-vitro assays to in-vivo studies
SOLVO suggest tailor-made solutions to optimize study design and the right combination of the appropriate assays
You can save money and time by choosing the most appropriate SOLVO P-gp assays for the different stages of your drug development

in-vitro assays and services
- Caco-2 and MDCKII-MDR1 monolayer assays are available at different levels of complexity: basic, custom besides the FDA setup. Transporter specific interactions can also be investigated with the use of P-gp substrates and inhibitors
- PREADYPORT^TM-MDR1: ready-to-use MDCKII-MDR1 monolayer Details
- P-gp PREDIVEZ^TM Kit: this vesicular transport assay is a unique high-throughput SOLVO technology that identifies compounds that interact with P-gp Details
- P-gp PREDEASY^TM Kit: high-throughput ATPase assay to distinguish substrates and inhibitors Details
- P-gp Calcein assay: proprietary cellular dye efflux assay Details
- NEW Rat brain endothelial cell monolayer assay Details
in-vivo services
- Rat brain microdialysis uses quinidine as reporter substrate, and PSC833 as a specific P-gp inhibitor Details

BCRP

in-vitro assays and services
- MDCKII-BCRP and MDCKII-mouse Bcrp monolayer assays: to investigate specific transporter interactions for medium to high permeability test articles Details
- PREDEASY^TM – BCRP Kit: high-throughput ATPase assay to distinguish BCRP substrates and inhibitors Details
- PREADYPORT^TM – BCRP: ready-to-use MDCKII-BCRP monolayer is under development

in-vivo services
- Rat brain microdialysis for Bcrp assessment Details
- Rat liver biliary excretion studies for Bcrp assessment Details

BSEP

in-vitro assays and services
- BSEP and mouse Bsep vesicular transport membrane preparations: high-throughput vesicular transport assay to identify compounds that interact with human BSEP or mouse Bsep Details
- mouseBsep PREDEASYTM Kit: high-throughput ATPase assay to distinguish mouse Bsep substrates and inhibitors Details

in-vivo service
- Rat liver biliary excretion studies for Bsep assessment Details

Ask for a quote: sales@solvo.com.

Download the complete lists of Products and Services provided by SOLVO Biotechnology.