Data Curation and Entry in DIDB – July Summary

In July, we added 73 citations in DIDB, including 35 in vitro (with 21 articles published in July 2022) and 38 in vivo articles (with 33 articles published in July 2022).

Two recently approved NDAs were also added: mavacamten (CAMZYOS), vutrisiran (AMVUTTRA).

Of note, all new drugs approved by the FDA from January to July this year (N = 16) have been curated in DIDB, and a DDI drug monograph for each drug was created.

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

As always, feel free to contact us if you have any questions or comments.

DDI Marker Studies Knowledgebase – quarterly update

The DDI Marker Studies Knowledgebase (replacing the previous combined and individual lists of CYP/P-gp substrates and perpetrators) has been updated in July 2022, and is available in the DIDB Resource Center.

In addition to substrates, inhibitors and inducers of CYPs and transporters, the Knowledgebase provides useful information on the compounds therapeutic class, clinical recommended dosage, pharmacokinetics (e.g. dose proportionality accumulation ratio, time to steady-state), QT prolongation, and NTI characteristics.

As always, feel free to contact us if you have any questions or comments.

Data Curation and Entry in DIDB – June Summary

In June, we added 76 citations in DIDB, including 31 in vitro (with 12 articles published in June 2022) and 45 in vivo articles (with 31 articles published in June 2022).

Four recently approved NDAs were also added: vonoprazan and amoxicillin and clarithromycin (VOQUEZNA TRIPLE PAK), oteseconazole (VIVJOA), tapinarof (VTAMA), tirzepatide (MOUNJARO)

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

As always, feel free to contact us if you have any questions or comments.

Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics – Guidance for Industry

The draft guideline published by the FDA on Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics is now available in DIDB Resource Center. Please note that you must be signed in to access.

This guideline provides recommendations for certain evaluations including pharmacokinetics, pharmacodynamic, and safety assessments during oligonucleotide therapeutic development.

A dozen of oligonucleotide drugs have been approved by the FDA and are included in DIDB. You will find data for evaluations recommended by the FDA guidance, e.g., QT interval prolongation, organ impairment, metabolism and transport DDI.

Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

The final guideline published by the FDA on Assessing the Effects of Food on Drugs in INDs and NDAs is now available in DIDB Resource Center. Please note that you must be signed in to access.

This guidance revises and replaces part of the 2002 FDA guidance entitled Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002). 

This guideline provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administrated drug products under INDs, to support NDAs, and supplements to these applications for drugs being developed under section 505 of the Federal Food, Drug, and Cosmetic Act. (21 U.S.C 335).

Note that clinical food effects data are curated by our DIDB Editorial Team. They are entered in DIDB as single drug PK studies with no precipitant. Changes in AUC, CL, and plasma concentrations are calculated for the fed state versus the control fasted state.

ICH Draft Guidance on Drug Interaction Studies

The first draft guidance newly released by ICH on “Drug Interaction Studies” is now available in DIDB Resource Center. Please note that you must be signed in to access.

The topic about Drug Interactions was endorsed by ICH Assembly in June 2018, and this draft is the first step towards a harmonized guidance.

This Guideline provides general recommendations on how to evaluate the DDI potential of an investigational drug. It is recognized that the DDI evaluation is generally tailored based on the specific drug, intended patient population, and therapeutic context. Alternative approaches can be used if they satisfy the requirements of the applicable statutes and regulations. The focus of the Guideline is the development of new drugs, but if new scientific information regarding the potential for DDIs is obtained after drug approval, additional DDI evaluation should be considered.

DDI Marker Studies Knowledgebase updated

The DDI Marker Studies Knowledgebase (replacing the previous combined and individual lists of CYP/P-gp substrates and perpetrators) has been updated and is available in the DIDB Resource Center.

Note, that we have initiated the gradual expansion of the Knowledgebase with more transporter data beyond P-gp. Thus, in this version, you will find data for BCRP and OATP1B1/1B3. More transporter data will be added throughout the year.

In addition to substrates, inhibitors and inducers of CYPs and transporters, the Knowledgebase provides useful information on the compounds therapeutic class, clinical recommended dosage, pharmacokinetics (e.g. dose proportionality accumulation ratio, time to steady-state), QT prolongation, and NTI characteristics

As always, feel free to contact us if you have any questions or comments.

UW Pharmacy’s Drug Interaction Database, built to promote medication safety, wins national innovation award

2022 marks 20 years of DIDB licensing and the selection by the ASCPT of Dr. René Levy and Dr. Isabelle Ragueneau-Majlessi to receive the 2022 Gary Neil Prize for Innovation in Drug Development.

Read the story here: https://www.washington.edu/news/2022/01/13/uw-pharmacys-drug-interaction-database-built-to-promote-medication-safety-wins-national-innovation-award/