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Regulatory Guidance

As regulatory authorities, such as the FDA, EMA, and PMDA, come out with updated guidance and calls for comment, our in-house experts frequently present and compose content to tell you what relevant updates mean for you as a drug developer.

 

Regulatory Documents

2020 FDA Draft Guidance, “Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry”

In August 2020, the FDA released the draft guidance for industry to evaluate therapeutic proteins for drug-drug interaction (DDI) potential using a risk-based approach.  ...
Blog

Drug-Drug Interaction (DDI) Prediction Models Following In Vitro Studies in Preclinical Development

In preclinical development, a drug will be evaluated for potential to cause a drug-drug interaction (DDI) using in vitro experiments and then calculations that...

Webinars

Comparison Between the Final US FDA, Japan PMDA, and EMA In Vitro DDI Guidance Documents: Are We Finally Harmonized?

Presenter: Brian Ogilvie, Ph.D., SEKISUI XenoTech Vice President of Scientific Consulting In January, the FDA published its final guidance for industry on in vitro drug-drug interaction (DDI) studies. Dr. Ogilvie...
Blog

What is ADME and how does it fit into drug development?

The main aim of drug development is to get a compound that has a therapeutic effect into the form of...

Webinars

The Basics of In Vitro Xenobiotic Metabolism and Drug-Drug Interaction Investigations: Applicability to All Xenobiotics

Since SOT’s 59th Annual Meeting and ToxExpo has been canceled due to COVID-19 concerns, we are bringing the tradeshow to you! SOT is hosting this...
Blog

How can in vitro and in vivo studies help me understand my drug’s clearance?

Systemic clearance, denoting how much drug is cleared from a volume of blood per unit of time, is of critical...

Scientific Posters

Comparison Between the Final US FDA, Japan PMDA and EMA In Vitro DDI Guidance

Comparison Between the Final US FDA (2020), the Final Japan PMDA (2018), and Final EMA (2013) In Vitro DDI Guidance Documents: Are We Finally Harmonized?...
Blog

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...

Blog

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...

Regulatory Documents

2020 FDA Final Guidance, “In Vitro Drug Interaction Studies– Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions”

We are proud to have been cited in this final guidance for industry document, which was released by the FDA in January 2020. Access full...
Blog

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...

Webinars

Are in vitro metabolism and DDI studies critical for an IND?

Presenter: Greg Loewen, Director of Technical Support at SEKISUI XenoTech Continuing our ADME 101 presentation series assisting researchers and industry professionals with navigating ADME, DMPK, and...
Blog

I Have My Data… Now What?

As a drug moves through the development pipeline, it undergoes a rigorous battery of safety assessments to prove it will...

Blog

The FDA has requested follow-up data… how do I fill in the gaps?

Because each new drug is unique in characteristics, such as chemical structure, mechanism of action, and physicochemical properties, there can...

Blog

Why You Need QWBA for Human Radiolabeled ADME Studies

A quantitative whole body autoradiography (QWBA) study provides data required for Human Radiolabeled ADME Studies1. Quantitative whole body autoradiography (QWBA) is an in...

Blog

Transporters of Emerging Importance in Drug Development: Beyond the Guidance Documents

Dr. Ogilvie’s presentation discussed critical literature and case studies which have been published since the FDA’s most recent guidance revision issued in...

Webinars

Transporters of Emerging Importance in Drug Development: Beyond the Guidance Documents

Presenter: Brian Ogilvie, Ph.D., SEKISUI XenoTech Vice President of Scientific Consulting Synopsis: In October, 2017, the US FDA revised and split its 2012 draft guidance for...
Blog

Official PMDA English Translation

The Japanese regulatory agent PMDA (Pharmaceuticals and Medical Devices Agency) recently published an official English translation of their final Drug Interaction Guideline...

Publications

2019 PMDA Guideline (English Translation), “Guideline on drug interaction for drug development and appropriate provision of information”

In 2019, the Phamraceuticals and Medical Devices Agency (PMDA) in Japan released the official English translation of their guidance for industry. Drug developers may also...
Blog

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...

Publications

2017 FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies

Dr. Brian Ogilvie, Andrea Wolff While the 2017 FDA DDI guidance contains many important changes, the earlier timing of drug-drug interaction studies is perhaps the most...
Blog

FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies

In October 2017, the FDA released its much-anticipated draft guidance documents for drug-drug interaction (DDI) studies, which was finalized in...

Blog

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...

Blog

October Presentations on In Vitro Effects of Biologics on CYP Enzymes and Regulatory DDI Guidances

On Oct. 15th at the Peptide ADME Discussion Group Workshop in Gothenburg, Sweden, Dr. Brian Ogilvie presented on In vitro Direct and Cytokine-Mediated...

Blog

To GLP or not to GLP?

That is the question. . . Knowing the answer may save you time and money Good Laboratory Practices (GLP) are...

Blog

Response to FDA Framework for Assessment of Drug-Drug Interactions for Therapeutic Proteins RFI and Comments

In July, Drs. Maciej Czerwinski, Director of Consulting, and Brian Ogilvie, Vice President of Scientific Consulting, submitted SEKISUI XenoTech’s comments in response to the...

Blog

IQ Induction Working Group Publishes Recommendations for Data Interpretation of In Vitro Induction – Focus on CYP3A4 mRNA

SEKISUI XenoTech is proud to have made contributions to the paper entitled, “Considerations from the IQ Induction Working Group in...

Blog

New Guidance on Bioanalytical Services

SEKISUI XenoTech offers bioanalytical services to support both internal groups and external clients. We have validated LC-MS/MS methods for human CYP markers,...

Blog

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:...

Scientific Posters

Current In Vitro DDI Regulatory Guidance (Reference Poster)

Brian W. Ogilvie1 and Andrew Parkinson2 1SEKISUI XenoTech, LLC, Kansas City, KS, USA and 2XPD Consulting, Shawnee, KS, USA Abstract: In September, 2017, the Japan PMDA revised its...
Blog

In Vitro DDI Regulatory Guidance Reference Poster

At the 2018 Marbach Castle Drug-Drug Interaction Workshop in Germany, Dr. Brian Ogilvie, Vice President of Scientific Consulting, presented a comparison...

Publications

In Vitro Products & Reagents Technology Guide

The 2017-2018 Product Technology Guide provides a complete list of SEKISUI XenoTech’s products as well as their uses and applications. This guide also has a...
Webinars

Comparison Between the US FDA, EU EMA and Japan PMDA In Vitro DDI Guidance Documents: Are We Close to Harmonization?

Hear more about updates in regulatory expectations for drug metabolism and DDI data between FDA, EMA, and PMDA
Webinars

Essential Considerations on the New FDA In Vitro DDI Guidance (the What, the Why, and the Wow)

Presenter: Brian Ogilvie, Ph.D., SEKISUI XenoTech Vice President of Scientific Consulting In October, the FDA revised and split its 2012 draft guidance for industry on in vitro drug-drug...
Blog

Initial Impressions of New Draft FDA DDI Guidance Documents from SEKISUI XenoTech

Updated Nov. 6th, 2017 The FDA has released its long-awaited new draft guidance for industry on drug-drug interaction (DDI) studies....

Publications

2017 FDA Draft Guidance, “”In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies”

Published by the FDA in 2017, this is the Draft guidance for industry, “In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies” You might also...
Blog

Considerations In Response to Drug-Drug Interaction Guidances

Check out the recent IQ consortium publication: Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidances from...

Publications

DDI Guidance Recommendations on Down-Regulation, CYP2C Induction and CYP2B6 Control

Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on Down-regulation, CYP2C Induction and CYP2B6 Positive Control...
Publications

2012 EMA Final Agency Guideline, “Guideline on the Investigation of Drug Interactions”

European Medicines Agency Guideline on the Investigation of Drug Interactions, revised June 2012. You might also be interested in our 2018 poster comparing current regulatory...
Blog

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...

Webinars

Navigating the Transporter Wave of 2013: A Review of the Seven Recent ITC Publications on Drug Transporters

Presented by: Greg Loewen, Amanda Hays and Andrea Wolff Seven papers were published by the International Transporter Consortium (ITC) in the July 2013 issue of Clinical...
Publications

2012 FDA Draft Guidance, “Drug Interaction Studies — Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations”

FDA 2012, Drug Interaction Studies- Study Design, Data Analysis, Implications for Dosing and Labeling Recommendations – DRAFT GUIDANCE Download Publication
Publications

2010 EMA Draft Guideline, “Guideline on the Investigation of Drug Interactions”

The European Medicines Agency released their “Guideline to the Investigation of Drug Interactions” draft guidance on April 22, 2010. Download Publication