100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
Previously searched by you
Previously searched by you
logo
Summary of the entire course Preclinical Drug Research (18/20) CA$20.49   Add to cart
Quickly navigate to
Preview
  2.  
  3. Universiteit Antwerpen (UA)
  4.  
  5. Biomedische Wetenschappen
  6.  
  7. Preclinical Drug Research (UA_2031FBDBMW)

Summary

Summary of the entire course Preclinical Drug Research (18/20)
 76 views  2 purchases
  • Course
  • Preclinical Drug Research (UA_2031FBDBMW)
  • Institution
  • Universiteit Antwerpen (UA)

Summary of the entire course Preclinical Drug Research (18/20): This is a compact summary of the whole course from the subject Preclinical Drug Research (slides, lectures, and all the important information from the insert) & elaboration of all the old exam questions from the course Preclinical Drug...

[Show more]

Preview 4 out of 75  pages

Document information

  • October 13, 2023
  • 75
  • 2023/2024
  • Summary

Subjects

  • preclinical
  • preclinical drug research
  • pharmacokinetics
  • delputte
  • biopharmaceuticals
  • vaccines
  • antibodies
  • biotechnology
  • biotechnological products
  • biomedical sciences
  • biomedische wetenschappen
  • uantwerpen

Written for

  • Universiteit Antwerpen (UA)
  • Biomedische Wetenschappen
  • Preclinical Drug Research (UA_2031FBDBMW)
All documents for this subject (22)

Seller

avatar-seller
lemmeslodders

Reviews received

Content preview

Full Summary of the course
Preclinical Drug Research

geschreven door

Bi0med




www.stuvia.com



Gedownload door: InnePatteet | inne.patteet@hotmail.be
Dit document is auteursrechtelijk beschermd, het verspreiden van dit document is strafbaar.

, Stuvia - Koop en Verkoop de Beste Samenvattingen




Preclinical drug research
Knowledge and insight in the process of drug discovery and preclinical development of pharmaceuticals
/ biologicals & interpret preclinical data in a registration file and recognize relevance to clinical research

INTRODUCTION
- Chemicals = small molecules E.g. aspirin, fluoxetine, omeprazole…
- Natural products = complex molecules E.g. vinblastine, artemether, paclitaxel…
- Biologicals = large (complex) molecules E.g. EPO, insulin, interferon..

Major disease areas: diseases of the circulatory, respiratory & digestive system, oncology, CNS,…
Major spending areas: Alzheimer, schizophrenia (CNS), cancer, diabetes, coronary disease, infections..

PHASES OF DRUG DEVELOPMENT:
1. Pre-human / pre-clinical stage
2. Clinical trials
a. Phase I: expose human volunteers (mostly males) to look at pharmacokinetics + look
at exposure / concentration levels. How is it absorbed, distributed, eliminated…
b. Phase II: enrol a real patients and a placebo group. Sometimes women enrolled.
i. IIa: small group IIb: bigger group
c. Phase III: large cohort of patients from different regions in the world. Costly.
3. Approval
4. Pharmacovigilance (phase IV): follow-up for side effects in large populations.
5. Uncategorized

Clinical trials are the most costly for the companies (57%), 21.5% the pre-clinical stage. This is why in
the best case drug attrition happens in the pre-clinical stage. Approval is 8.3%, phase IV is 9.8%.

The age group of your population should be taken into account because certain organ systems don’t
work optimal anymore. This could mean other concentration levels are present in older people. The
people get older so we’ll have to deal with age-related diseases and co-morbidities. As you get older
the healthcare spending increases. E.g. osteoporosis, arthritis, prostate cancer, type II diabetes.

The total cost for one new marketed drugs is about 0.8 to 1.5 billion USD. BUT this is largely dependent
on therapeutic area. Some diseases are less interesting for pharmaceutical companies because of a
lower income. E.g. tropical diseases, orphan diseases (low number of patients), pediatric diseases..

Companies have a limited time to sell as much as they can of a certain drug. By investing in generics
they avoid competition.




Gedownload door: InnePatteet | inne.patteet@hotmail.be
Dit document is auteursrechtelijk beschermd, het verspreiden van dit document is strafbaar.

, Stuvia - Koop en Verkoop de Beste Samenvattingen




These phase durations can vary




It takes 10-15 years for a
drugs to make it to the
market but in this period
you already need your
patent because you
want to protect it from
competitors



The pre-clinical development stage happens over and over again before every other phase because for
each phase to start you need a pre-clinical package, depending on the clinical phase. It also differs if
you want to include women, children, old people… It is thus not 100% correct to say the pre-clinical
phase happens first and then the clinical phases. They are interfering with each other.


BLOCKBUSTER DRUGS (SALES > 1 BILLION USD/YEAR)
= Ab for juvenile arthritis

= Ab against long cancer




Most of these are biologicals. Small
biotech companies are bought up by
large pharma companies.

Roche is the biggest player because of 3
blockbusters.


70% of the income of big pharmaceutical companies come from 20% of the drugs marketed. This is the
reason companies are buying up each other. A lot of companies are outsourcing pre-clinical studies to
contract research organizations, which is more profitable. These are bought up by big pharma.




Gedownload door: InnePatteet | inne.patteet@hotmail.be
Dit document is auteursrechtelijk beschermd, het verspreiden van dit document is strafbaar.

, Stuvia - Koop en Verkoop de Beste Samenvattingen




30% of the challenges are linked to generic
competition. Why would you pay for a drug with
a patent which will be more expensive, if you
could get a generic, cheaper drug. Dafalgan
would be more expensive than a generic one.

Price containment: when you get a FDA approval,
you need to discuss with each member state how
much you can charge for it.

Poor product differentiation: a drugs can not be approved because it’s essentially the same than one
that is already on the market. ~ Increased competition from “me-too” drugs

Parallel importation: normally you have a provider which is importing the drug, but it’s possible to
get importations from other countries, where the price setting can be different.

Counterfeiting of drugs: fraud. People are buying medication on the internet, for example against a
headache. In some cases these drugs have not been tested and can contain other solvents. ‘Fakes’.



PRODUCT POSITIONING
1. Generics (without a patent) have a lot of sales. It’s easily
accessible so high-sales volume but also high competition. Low
medical differentiation

2. Targeted therapeutics (niche drugs): only for a specific
indication occurring in a small population. This means a very
high medical differentiation (valuable), but because of the
niche, the sales are low. High medical differentiation

3. Mega-blockbusters (large chronic markets): high sales with not too much competition.



FAILURE RATES IN DRUG DEVELOPMENT
It’s important to detect toxicity or non-efficacy as
early as possible. This is why most compounds fail in
pre-clinical development.

In phase I there is still a lot of attrition since this is
where you include human volunteers. Here you will
detect for example no absorption.

Lack of efficacy and PK are the most common causes
for drug attrition. Animal toxicology makes 10%.

Most drugs target the GPCR. A lot of others work on other receptors or transporters. Some HIV
medication is effective but since it’s easily metabolized it gives low exposure levels. Here they combine
the drugs with an enzyme blocker.

Biologicals often have lower toxicity.


Gedownload door: InnePatteet | inne.patteet@hotmail.be
Dit document is auteursrechtelijk beschermd, het verspreiden van dit document is strafbaar.

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

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

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

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 lemmeslodders. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for CA$20.49. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

75323 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling
CA$20.49  2x  sold
  • (0)
  Add to cart