Bioanalytical Community

Hi All,

As you may be aware, the Japan PMDA recently published a draft immunogenicity guideline. There is no official translation of this draft guideline document - we attach a DeepL translated version, which we are reliably informed is reasonably accurate. Please note: this is a machine-translated version, so the English is not perfect. 

The deadline for public comment is quite short, but the AAPS Immunogenicity Discussion Group is coordinating an effort to give the opportunity to immunogenicity experts within the AAPS community to review and provide comment. 

If you would like to participate in this feedback, please message Todd and myself and we will provide details (already sent out to IDG participants). There is an aggressive timeline/deadline on AAPS community feedback: Friday 23 February 2024, 12.00 Eastern US, 18:00 CET.

Thanks,
Rob & Todd

[email protected]

[email protected]

Hi All,

As you may be aware, the Japan PMDA recently published a draft immunogenicity guideline. There is no official translation of this draft guideline document - we attach a DeepL translated version, which we are reliably informed is reasonably accurate. Please note: this is a machine-translated version, so the English is not perfect. 

The deadline for public comment is quite short, but the AAPS Immunogenicity Discussion Group is coordinating an effort to give the opportunity to immunogenicity experts within the AAPS community to review and provide comment. 

If you would like to participate in this feedback, please message Todd and myself and we will provide details (already sent out to IDG participants). There is an aggressive timeline/deadline on AAPS community feedback: Friday 23 February 2024, 12.00 Eastern US, 18:00 CET.

Thanks,
Rob & Todd

[email protected]

[email protected]