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 Guidance
Blog
Are in vitro drug metabolism and drug-drug interaction studies critical for an IND?
A Guide to What, Why & When to Conduct ADME Studies When drug developers are preparing their IND, drug metabolism...
Webinars
Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies Guideline and Comparison with Current Guidance
Presenter: Brian Ogilvie, Ph.D, Vice President of Scientific Consulting at XenoTech In June 2022, the ICH released the first draft of its harmonized Drug Interaction Studies Guideline (M12). The...
Blog
New FDA Draft Guidance “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics” – XenoTech’s perspective on in vitro DDI testing
The FDA has released a new draft guidance for industry titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.”...
Regulatory Documents
2022 FDA Draft Guidance for Industry “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”
“This guidance provides recommendations to assist industry in the development of oligonucleotide therapeutics under section 505 of the Federal Food, Drug, and Cosmetic Act (21...
Regulatory Documents
2022 ICH M12 Draft Guideline for Drug Interaction Studies
“In clinical practice, patients are often prescribed more than one drug which can result in a DDI (drug-drug interaction). Some patients, in particular fragile older...
Webinars
Filing an IND and Beyond: Development of CTD Section 2.6.4, Pharmacokinetics Written Summary
Presenter: Griff Humphreys, Ph.D, XenoTech Consultant Recorded keynote presentation from XenoTech’s 2022 Seminar Series. Learn about what this important section consists of, the studies that...
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2020 FDA Draft Guidance, “Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry”
In August 2020, the FDA released the draft guidance for industry to evaluate therapeutic proteins for drug-drug interaction (DDI) potential using a risk-based approach. “The...
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., 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 will...
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...
Regulatory Documents
Safety Testing of Drug Metabolites (“MIST”)
In March 2020, FDA updated this guidance to provide “recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity...
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...
Webinars
Drug Metabolism Related Safety Considerations in Drug Development
Approximately 30 years ago, sub-optimal DMPK properties were recognized as the primary contributor to the failure (~40%) of potential new therapies in early clinical trials. This observation precipitated a renaissance period across the discipline which served to align DMPK efforts within discovery to assist in selecting optimal drug candidates to advance to clinical testing...
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...
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 discusses critical literature and case studies which have been published following the FDA’s 2017 guidance revision, and covered...
Webinars
Transporters of Emerging Importance in Drug Development: Beyond the Guidance Documents
Presenter: Brian Ogilvie, Ph.D., XenoTech Vice President of Scientific Consulting Synopsis: In October, 2017, the US FDA revised and split its 2012 draft guidance for industry...
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 Pharmaceuticals 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 XenoTech’s comments in response to the Food...
Blog
IQ Induction Working Group Publishes Recommendations for Data Interpretation of In Vitro Induction – Focus on CYP3A4 mRNA
XenoTech is proud to have made contributions to the paper entitled, “Considerations from the IQ Induction Working Group in Response...
Blog
New Guidance on Bioanalytical Services
XenoTech offers bioanalytical services to support both internal groups and external clients. We have validated LC-MS/MS methods for human CYP markers, UDP...
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:...
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 Product Technology Guide provides a complete list of XenoTech’s products as well as their uses and applications. This guide also has a comprehensive appendix...
Blog
Initial Impressions of New Draft FDA DDI Guidance Documents from 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” “This guidance is...
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
Regulatory Documents
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
In January 2010, FDA issued this document to “recommend international standards for, and promote harmonization of, the nonclinical safety studies recommended to support human clinical...