News

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.

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.

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.

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.

In May, we added 74 citations in DIDB, including 29 in vitro (with 15 articles published in May 2022) and 45 in vivo articles (with 32 articles published in May 2022).

One recently approved NDA was also added: Ganaxolone (ZTALMY)

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.

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.

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.