ISSX Posters available in the Resource Center

The posters presented at the 12th International ISSX Meeting in Portland by the DIDB team are now available in the Resource Center’s DIDB Team’s Most Recent Communications section:

  • “Main mechanisms of PK DDIs triggering label recommendations for drugs approved by FDA in 2018” (Dr. Jingjing Yu et al.)
  • “Variability of OATP1B1/1B3 in vitro inhibition constants and the resulting impact on clinical evaluation” (Dr. Savannah McFeely et al.)

Update of our website to come soon

We will be updating the homepage and the public content of our website over the coming few weeks, with an early version released next week. Our new program name, UW Drug Interaction Solutions, reflects our expanding activities and offerings. You can view/download a new brochure and technical flyers on our redesigned homepage.

Note that once you have logged in, the web pages dedicated to subscribers have not changed and you will find all the queries, functions, and editorial content you are used to.

We have also launched a LinkedIn page for UW Drug Interaction Solutions where you can find the most recent news and events regarding the program.

Dr. Jingjing Yu to present new NDA data at the upcoming 6th Asia Pacific ISSX Meeting

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.

New Manuscript in Drug Metabolism and Disposition

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.

New “Overall Effect” for in vivo studies to include absorption-based DDIs

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.

New FDA guidance documents available in the Resource Center

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

November Newsletter available in the Resource Center as well as ISSX poster presentations

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.

DIDB Team to participate in the upcoming ISSX Meeting – Orlando 10/18-10/22, 2015

Please visit the DIDB Team at Booth #312 during this year’s ISSX Meeting to be held in Orlando October 18th-22nd, 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 19th, 12:30-2:00 pm (Dr. Sophie Argon)
  • Presentation by Author: Wednesday, October 21st, 12:45-1:30 pm (Dr. Sophie Argon)
  • Oral Communication in Parallel Symposium 3: Tuesday, October 20th, 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 19th, 12:30-2:00 pm (Dr. Jingjing Yu)
  • Presentation by Author: Wednesday, October 21st, 12:45-1:30 pm (Dr. Jingjing Yu)
  • Oral Communication in New Investigators Session: Monday, October 19th, 4:45-5:00 pm (Dr. Jingjing Yu)