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Author: Greg Loewen

Can Interactions Between Therapeutic Proteins and Small Molecule Drugs Be Evaluated In Vitro?

The mechanisms of clearance for small molecule drugs and therapeutic proteins are fundamentally distinct and therefore therapeutic proteins are generally not...

Important Considerations for the Conduct of In Vitro Drug Transporter Assays

Not only can drug transporters affect the absorption and excretion of drugs, they can be involved in pharmacokinetic-based drug-drug interactions...

Coverage from the October 2018 PBSS DDI Workshop

The Pharmaceutical and BioScience Society (PBSS) hosted the workshop “Drug-Drug Interactions: Update on Risk Assessment, Clinical Evaluation and Regulatory Requirements” on October...

AAPS-FDA Drug Transporters

The American Association of Pharmaceutical Scientists (AAPS) and U.S. Food and Drug Administration (FDA) co-sponsored the workshop “Drug Transporters in ADME:...

Navigating the Transporter Wave of 2013

The International Transporter Consortium (ITC) issued 7 papers in the July 2013 issue of Clinical Pharmacology & Therapeutics. These 7...

Timing of In Vitro Studies: Early, Thorough ADME for Your Compound’s Success

Beyond the need for evidence that a drug works, Food and Drug Administration (FDA) and other regulatory bodies around the...

How Can I Make Sure My Data Meets Regulatory Expectations?

Regulatory authorities publish updated guidance documents that share their expectations for endpoints and test systems with drug developers, but sometimes it is difficult to...

What In Vitro Metabolism and DDI Studies Do I Actually Need?

Though there is no ‘roadmap’ spelling out required studies to achieve regulatory approval for clinical entry, a drug candidate’s metabolism...

Improve the Value of Your Molecule's Testing with Expert Insight

Our expert team of DDI and drug metabolism consultants can help you piece together the data for a successful data package that meets regulatory expectations for thorough risk assessment of a new or repurposed compound

Read our Follow-Up Interview in Outsourcing Pharma

Find the Q&A between Director of Scientific Consulting, Dr. Maciej Czerwinski, and the editorial team at Outsourcing Pharma for more answers about how DDI testing and data interpretation adds value to the drug repurposing process

Human antibodies, including monoclonal and polyclonal, are used for inhibition and immunoblot applications