Invalid TSVAL value for TRT

TSVAL/TSVALCD value mismatch for TRT

The latest implemented version of UNII seems to be 2018-10-25, so already pretty old.
Such checks should essentially be done using RESTful web services, such as the ones already provided by the FDA at https://www.accessdata.fda.gov/scripts/ora/pcb/apidocs/.

However, Pinnacle21 Validator does not use such modern RESTful web services yet.

Dear Jozef,Thanks for your…

Dear Jozef,

Thanks for your support. We have went through the link which you have provided. upon going through that, we tried updating the Product name and Product code under REST endpoints.

Is it that upon feeding the Product name in REST endpoints Parameter text box will directly reflect in the Pinnacle21 V3.0 and my error will get resolved?

or 

My error cannot be resolved for now at all and we can go ahead and capture this error related details in the reviewer's guide?

 

TSVAL/TSVALCD value mismatch for TRT and RESTful web services

I haven't used this RESTful web service myself yet, so cannot give you any support. Please contact the FDA helpdesk for this service (ORAAPIRequests@fda.hhs.gov). They will be glad to help you further.

AND ...

Pinnacle21 does NOT use any RESTful web services at all - they are not that modern yet. So any updates to the FDA database will NOT immediately be reflected in the Pinnacle21 software and the validation results. You will have to wait until they update the UNII files that come with the software. Might take a while ...
Best solution is to document this error as a false positive in the Reviewers Guide.

With best regards,

Jozef Aerts
XML4Pharma

 

TSVAL/TSVALCD value mismatch for TRT and RESTful web services

I had a quick try and got it to work - you should not enter username and key simultaneously, but first only your username, and in a second step your key.

And YES, "Levothyroxine Sodium" is ALREADY in the system, as you can see from the result:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

So indeed => false positive => reviewers guide

I also looked into the latest (well, 2018) UNII file provided with the Validator software - it does not contain anything like "Levothyroxine".

With best regards,

Jozef Aerts
XML4Pharma

Dear Jozef, Thanks for your…

Dear Jozef,

Thanks for your valuable support. We will capture the False Positive in the Reviewer's guide as you suggested. I believe that this will be updated in the upcoming Pinnacle 21 versions.

Bharath,

NAVITAS LLP