Dr. Jingjing Yu will be contributing to the Second Nordic Conference on Personalized Medicine (June 14-16, 2023 – Turku, Finland) with a presentation entitled “Drug-Drug Interactions in the New FDA Therapy Approvals: Mechanism and Clinical Significance“.
News
DIDB Team to participate in the 2023 Marbach DDI Workshop, June 4-6, in Germany
Drs. Isabelle Ragueneau-Majlessi and Jingjing Yu will give two talks at the upcoming 2023 Marbach DDI workshop, June 4-6, Marbach Castle, Germany.
Dr Isabelle Ragueneau-Majlessi will speak about the “Important Methodological Aspects of Smoking Interactions Studies – Review of three Decades of Literature”.
Dr Jingjing Yu will present an”Overview of 2022 NDA Reviews: Understanding the Risk of Metabolism- and Transporter-Based Drug-Drug Interactions with Novel Drugs Approved by the US FDA”.
Data Curation and Entry in DIDB – April Summary
In April, we added 111 citations in DIDB, including 40 in vitro (with 11 articles published in April 2023) and 71 in vivo articles (with 43 articles published in April 2023).
Four recently approved NDAs were also added: elacestrant (ORSERDU), omaveloxolone (SKYCLARYS), trofinetide (DAYBUE), zavegepant (ZAVZPRET).
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.
Data Curation and Entry in DIDB – March Summary
In March, we added 105 citations in DIDB, including 51 in vitro (with 16 articles published in March 2023) and 54 in vivo articles (with 38 articles published in March 2023).
Three recently approved NDAs and BLAs were also added: daprodustat (JESDUVROQ), pirtobrutinib (JAYPIRCA), velmanase alfa (LAMZEDE).
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 April 2023, and is available in the DIDB Resource Center.
In this update, 38 compounds were identified as substates, inhibitors, and inducers of CYP enzymes and transporters (P-gp, BCRP, and OATP1B1/3). Among them, 6 compounds (16%) could lead to strong drug interactions mediated by CYP3A and CYP2D6.
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 – 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.
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
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.
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
- Robert Hermann
- Amin Rostami-Hodjegan
- Ping Zhao
- Isabelle Ragueneau-Majlessi
Clin Transl Sci. 2023 May;16(5):742-758
- PMID: 36752279
- doi: 10.1111
- Semantic Scholar
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.
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.