News

 |  News

Data Curation and Entry in DIDB – February Summary

In February, we added 94 citations in DIDB, including 38 in vitro (with 16 articles published in February 2023) and 56 in vivo articles (with 38 articles published in February 2023).

Seven recently approved NDAs and BLAs were also added: anacaulase (NEXOBRID), bexagliflozin (BRENZVVY), lecanemab (LEQEMBI), lenacapavir (SUNLENCA), mosunetuzumab (LUNSUMIO), ublituximab (BRIUMVI), xenon Xe-129 hyperpolarized (XENOVIEW). 

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.

 |  News

Our first EUA, paxlovid, available in DIDB

We are pleased to announce the inclusion of FDA-issued Emergency Use Authorization (EUA) data in DIDB for PAXLOVID (nirmatrelvir and ritonavir) authorized for Covid-19 treatment.

Our DIDB editorial team has curated and entered in DIDB, all relevant pharmacokinetic (food effect, hepatic impairment, …) and drug interaction data (CYP3A, P-gp, …) obtained from CDER reviews. 

You can review PAXLOVID comprehensive DDI drug monograph and search preclinical and clinical studies, case reports, modeling and simulation data of this combination drug and its components using various DIDB queries after login to DIDB and access the data here: https://lnkd.in/gr5QkpJK

 |  News

Data Curation and Entry in DIDB – January Summary

In January, we added 121 citations in DIDB, including 58 in vitro (with 26 articles published in January 2023) and 63 in vivo articles (with 33 articles published in January 2023).

Two recently approved NDAs and BLAs were also added: adagrasib (KRIAZATI), teplizumab (TZIELD) 

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.

 |  Publications
Tags: , , ,

Seeing what is behind the smokescreen: A systematic review of methodological aspects of smoking interaction studies over the last three decades and implications for future clinical trials

Clin Transl Sci. 2023 May;16(5):742-758

Abstract

Smoking drug interaction studies represent a common approach for the clinical investigation of CYP1A2 induction. Despite this important role, they remain an “orphan topic” in the existing regulatory framework of drug interaction studies, and important methodological aspects remain unaddressed. The University of Washington Drug Interaction Database (DIDB) was used to systematically review the published literature on dedicated smoking pharmacokinetic interaction studies in healthy subjects (1990 to 2021, inclusive). Various methodological aspects of identified studies were reviewed. A total of 51 studies met all inclusion criteria and were included in the analysis. Our review revealed that methods applied in smoking interaction studies are heterogeneous and often fall short of established methodological standards of other interaction trials. Methodological deficiencies included incomplete description of study populations, poor definition and lack of objective confirmation of smoker and nonsmoker characteristics, under-representation of female subjects, small sample sizes, frequent lack of statistical sample size planning, frequent lack of use of existing markers of nicotine exposure and CYP1A2 activity measurements, and frequent lack of control of extrinsic CYP1A2 inducing or inhibiting factors. The frequent quality issues in the assessment and reporting of smoking interaction trials identified in this review call for a concerted effort in this area, if the results of these studies are meant to be followed by actionable decisions on dose optimization, when needed, for the effects of smoking on CYP1A2 victim drugs in smokers.

 |  News

Data Curation and Entry in DIDB – December Summary

In December, we added 94 citations in DIDB, including 50 in vitro (with 22 articles published in December 2022) and 44 in vivo articles (with 37 articles published in December 2022).

Three recently approved NDAs and BLAs were also added: mirvetuximab soravtansine (ELAHERE), olutasidenib (REZLIDHIA), sodium phenylbutyrate and taurursodiol (RELYVRIO) 

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.

 |  News

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 January 2023, and is available in the DIDB Resource Center.

We continue to expand the Knowledgebase by adding more transporter data. In this update, 18 compounds were identified as substates/inhibitors/inducers of CYP enzymes and transporters (P-gp, BCRP, and OATP1B1/3). Among them, 2 compounds could lead to strong drug interactions.

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.

 |  New features

Video Tutorials – Increased Visibility

Did you know that we have recorded 10 training videos so far, which are all available in the DIDB Resource Center?

In order to best benefit the DIDB users, the videos are now also accessible on the DIDB pages that are relevant to their content. For example, on the Drug Query page you have access to 3 related videos, on the QT Interval page to 1 related video …

Please note that you must be signed-in to access.

Feel free to suggest additional topics for training videos that you will find useful. Please contact us. Thank you.

 |  News

Data Curation and Entry in DIDB – November Summary

In November, we added 119 citations in DIDB, including 61 in vitro (with 24 articles published in November 2022) and 58 in vivo articles (with 34 articles published in November 2022).

Three recently approved NDAs and BLAs were also added: futibatinib (LYTGOBI), teclistamab (TECVAYLI), tremelimumab (IMJUDO).

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.

 |  News

Data Curation and Entry in DIDB – October Summary

In October, we added 134 citations in DIDB, including 51 in vitro (with 29 articles published in October 2022) and 83 in vivo articles (with 40 articles published in October 2022).

Five recently approved NDAs and BLAs were also added: daxibotulinumtoxina (DAXXIFY), deucravacitinib (SOTYKTU), eflapegrastim (ROLVEDON), omidenepag isopropyl (OMLONTI), and terlipressin (TERLIVAZ).

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.

 |  News

Data Curation and Entry in DIDB – September Summary

In September, we added 137 citations in DIDB, including 70 in vitro (with 36 articles published in September 2022) and 67 in vivo articles (with 40 articles published in September 2022).

Two recently approved BLAs were also added: olipudase alfa (XENPOZYME), spesolimab (SPEVIGO).

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.