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0:00
Hello. My name is David Jones,
and I'm an Independent
Consultant
in Pharmacotoxicology.
My previous life was
as an assessor at
the Medicines and Healthcare
Products Regulatory
Agency in the UK,
where I spent 25
years as an assessor,
primarily working within
the clinical trials unit.
0:22
We all know about ICH.
We all know where ICH came from,
and in fact, it's been
around now since about 1990,
and ICH meetings are
still held twice a year.
The ICH S3A Note for
Guidance on Toxicokinetics
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came into regulatory
acceptance in 1994.
The S3B guideline
on pharmacokinetics
also came into being
in October 1994,
and a questions and
answer document on S3A,
which focused on microsampling
and which I was the
rapporteur for the EU
was adopted in November 2017.
1:09
You should also note
that there is a section
on toxicokinetics
and pharmacokinetics
in the ICH M3(R2) Guidance on
Nonclinical Safety Studies
for the Conduct of
Human Clinical Trials and
Marketing Authorisation
for Pharmaceuticals.
This discusses the
timings of these studies,
and the guideline is
actually a subject
of another talk in this series.
Pharmacokinetics and
toxicokinetics for
biotechnology derived
pharmaceuticals are covered
in the ICH S6 (R1) guideline.
This also is a subject of
another talk in this series.
Finally, the ICH
S12 guideline on
Nonclinical Biodistribution
Considerations for
Gene Therapy Products was
adopted in March 2023.
Once again, this
guideline is also
the subject of another
talk in this series.
