Summary
Samenvatting Les 11 'Paediatric drug development'
- Course
- Institution
This document includes the summary of Lesson 11 (info slides with notes) of the “Preclinical drug research” course.
[Show more]
Seller
Follow
evagoormans
Content preview
Lecture 11: 10/11- 4/12Paediatric drug development
- Almost no drugs on the market that been qualified for the paediatric popula9on
o Up to children it is o;en off label -> none of the drugs have been approved to give
to children
- Problem with chloramphenicol
o Baby’s can undergo sep9s -> need treatment -> an9bio9cs
o Grey baby syndrome because they get a cardiovascular collaps -> blood supply
goes only to the cri9cal organs and not to the skin
o It is metabolized by the phase 2 enzymes -> most of these are not mature in
neonatal baby’s.
o Dose should be much lower for children because they don’t have the enzyme to
metabolise the compound
- In 2016 the landscape has been reshuffled
- For each drug that you want to bring on the market you need to have a pediatric
inves9ga9on plan
o You have to think about the impact of the compound on children -> ra9onale
Regula'on
- No improved PIP by the regulators you will not get the drug on the market
o Cost extra recourses
- If you want to be on 9me with the process you need to think about PIP in the clinical
phase II
- Good way to push forward that children should be treated with drugs that are been
controlled and be approved for them
- PIP = Pediatric Inves9ga9on Plan
o Show to the regulators your inten9on. Even is the drug being not suitable for the
children then you s9ll have to submit it -> ask for a waver (you dom’t need to do
anything)
§ You can ask for a refuel: you could poten9ally bring the drug on the market
for adults
o A lot of drugs fail in phase 1 -> most companies do that during phase 2 for being
on 9me for poten9al marke9ng on 9me
§ In prac9ce prior in phase III
o Clinical program
§ Clinicals need to make up their mind.
§ Dura9on
o Preclinical package
o Chemical pharmaceu9cal
§ Cri9cal
• Tablet that is very big -> a children will not be able to take this up. O;en
a syrupe is used.
§ Pharmaceu9cal development
The paediatric commi4ee
- For each of the Europe countries you have a represen9ve
- CHMP
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller evagoormans. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $6.73. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
73243 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now