Category: News

Dr. Jingjing Yu will be presenting a poster entitled “ANALYSIS OF IN VITRO TO IN VIVO PREDICTIONS OF TRANSPORTER-MEDIATED INHIBITION DRUG INTERACTIONS FOR DRUGS APPROVED BY THE US FOOD AND DRUG ADMINISTRATION BTEWEEN 2013 AND 2016” at the upcoming 6th Asia Pacific ISSX Meeting in Hangzhou, China, May 11 – 14, 2018.

The poster will be on display throughout the meeting and poster presentation sessions will be held on Saturday, May 12th and Sunday, May 13th.

Our most recent publication entitled “Risk of Clinically Relevant Pharmacokinetic-based Drug-drug Interactions with Drugs Approved by the U.S. Food and Drug Administration Between 2013 and 2016” by Yu et al. is now available on Drug Metabolism and Disposition online FastForward site (https://dmd.aspetjournals.org). This is an extensive review of the NDA data we analyzed for the DIDB platform, with useful supplemental tables summarizing the main clinical findings.

Do not hesitate to contact us if you have any questions.

As a result of our continuous efforts to expand the DIDB platform coverage of pharmacokinetic-based drug interactions beyond metabolism and transport, the following new “Overall Effect” categories are now available for in vivo DDI studies:

• In Vivo Other Mechanism >20% Effect
• In Vivo Other Mechanism No Effect

With the following Study subtypes

1. pH dependency (absorption)
2. Binding/chelation (absorption)
3. Gastrointestinal motility (absorption)
4. Plasma protein binding displacement (distribution)
5. Enzyme down-regulation/up-regulation reversal (metabolism)
6. Complex/multifactorial mechanism

As we increase the number of citations pertaining to these mechanisms, you will start seeing these new studies in the queries (dropdown menus) and their results. As a first step, we entered all pH-dependent DDI evaluations (both negative and positive results) with proton pump inhibitors and we will continue adding absorption-based DDIs to the platform during the coming months.

Should you have questions, comments or concerns, please contact us.

The two new FDA guidance documents on drug-drug interactions have been added to the “Regulatory Guidances” section of the DIDB Resource Center. Please note that you must be signed in to access.

• Clinical Drug Interaction Studies (Oct. 2017). Draft Guidance
• In Vitro Metabolism- and Transport-Mediated Drug-Drug Interaction Studies (Oct. 2017). Draft Guidance

DIDB Editorial Team

Two new FDA guidance documents (released in December 2016) have been added to the “Regulatory Guidances” section of the DIDB Resource Center. Please note that you must be signed in to access.

• Physiologically Based Pharmacokinetic Analyses- Format and Content. Draft Guidance
• Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

DIDB Editorial Team

The November Newsletter is now available. You can see this and past newsletters in the DIDB Resource Center. Please note that you must be signed in to access.

Also available in the Resource Center under “DIDB Team’s Communication” are the two posters presented at the last ISSX meeting in Orlando:

• SYSTEMATIC REVIEW OF THE QUANTITATIVE DRUG EXPOSURE DATA AVAILABLE IN THE PHARMACOGENETIC LITERATURE USING THE UNIVERSITY OF WASHINGTON E-PKGENE© APPLICATION IDENTIFIES DRUGS MOST SENSITIVE TO GENETIC VARIATIONS (Sophie Argon, Todd M Smith, Zhu Zhou, Isabelle Ragueneau-Majlessi).
• WHAT CAN BE LEARNED FROM THE NDA AND BLA REVIEWS OF NEWLY APPROVED DRUGS? A SYSTEMIC REVIEW OF DRUG INTERACTION DATA FOR DRUGS APPROVED BY THE US FDA IN 2014 (Jingjing Yu, Tasha K. Ritchie, Zhu Zhou, Isabelle Ragueneau-Majlessi).

Do not hesitate to contact us with comments or suggestions.

Please visit the DIDB Team at Booth #312 during this year’s ISSX Meeting to be held in Orlando October 18^th-22^nd, 2015.

Also, please come to the following poster and oral presentations:

• P224 – SYSTEMATIC REVIEW OF THE QUANTITATIVE DRUG EXPOSURE DATA AVAILABLE IN THE PHARMACOGENETIC LITERATURE USING THE UNIVERSITY OF WASHINGTON E-PKGENE© APPLICATION IDENTIFIES DRUGS MOST SENSITIVE TO GENETIC VARIATIONS (Sophie Argon, Todd M Smith, Zhu Zhou, Isabelle Ragueneau-Majlessi).
• Poster Networking: Monday, October 19^th, 12:30-2:00 pm (Dr. Sophie Argon)
• Presentation by Author: Wednesday, October 21^st, 12:45-1:30 pm (Dr. Sophie Argon)
• Oral Communication in Parallel Symposium 3: Tuesday, October 20^th, 11:45 am-12:00 pm (Dr. Sophie Argon)

• P112 – WHAT CAN BE LEARNED FROM THE NDA AND BLA REVIEWS OF NEWLY APPROVED DRUGS? A SYSTEMIC REVIEW OF DRUG INTERACTION DATA FOR DRUGS APPROVED BY THE US FDA IN 2014 (Jingjing Yu, Tasha K. Ritchie, Zhu Zhou, Isabelle Ragueneau-Majlessi).
• Poster Networking: Monday, October 19^th, 12:30-2:00 pm (Dr. Jingjing Yu)
• Presentation by Author: Wednesday, October 21^st, 12:45-1:30 pm (Dr. Jingjing Yu)
• Oral Communication in New Investigators Session: Monday, October 19^th, 4:45-5:00 pm (Dr. Jingjing Yu)

UW School of Pharmacy Pharmaceutics Clinical Professor Isabelle Ragueneau-Majlessi has been named a UW CoMotion… more…

Dr. Isabelle Ragueneau-Majlessi, Clinical Professor and Director of the DIDB Program, is an invited speaker at the session entitled “Overcoming potential setbacks? Prediction of Drug-Drug interactions via Computational Modeling“, taking place on Wednesday November 5th (7:00-8:30am) at the AAPS Meeting in San Diego. She will be presenting on “Indexing and Curating Drug-Drug Interaction Data: experience of the University of Washington Drug Interaction Database”.

Please visit the DIDB Team at Booth #408 during this year’s ISSX/JSSX Meeting to be held in San Francisco October 19 -23, 2014.

Also, please come to the following poster presentations:

• P94 – ASSESSMENT OF THE IMPACT OF RENAL OR HEPATIC IMPAIRMENT VS PHARMACOLOGIC INHIBTION ON SYSTEMIC EXPOSURE OF DRUGS (Cathy Yeung, Makiko Kusama, Huixia Zhang, Isabelle Ragueneau-Majlessi, Sophie Argon, Li Li, Peter Chang, Ping Zhao, Lei Zhang, Kenta Yoshida, Issam Zineh, Yuichi Sugiyama, Shiew-Mei Huang).
• Monday October 20
• Presented by Authors: 1:15 – 2:00 pm  (Dr. Cathy Yeung)

• P173 – DRUG DISPOSITION AND DRUG-DRUG INTERACTION DATA IN 2013 FDA NEW DRUG APPLICATIONS: A SYSTEMATIC REVIEW (Jingjing Yu and Isabelle Ragueneau-Majlessi).
• Monday October 20
• Presented by Authors: 4:30-5:15 pm (Dr. Jingjing Yu)

• P390 – USE OF IN VIVO DISPOSITION DATA TO DETERMINE CYP2D6 PROBE fm VALUES AND DEVELOP PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELS TO PREDICT GENOTYPE DEPENDENT CYP2D6-MEDIATED DRUG-DRUG INTERACTIONS (Mariko Nakano, Jingjing Yu, Sophie Argon, Isabelle Ragueneau-Majlessi, Nina Isoherranen).
• Tuesday October 21
• Presented by Authors: 6:15-7:00 pm (Dr. Mariko Nakano)