Summary
Summary HPI4001 Case 5 The Pharmaceutical Market
- Course
- Institution
Complete summary of case 5 of HPI4001 Economics of Healthcare
[Show more]
Seller
Follow
Sophiex123
Content preview
Case 5 The pharmaceutical market 15-10-2022How does a drug come into the market?
Drug development process
Stages of drug development
1. Pre-clinical studies: test tubes,
laboratory, animal testing
2. Clinical studies: Phase I + II + III
clinical trials
a. Phase 1: small group of
health volunteers. To
evaluate safety and
determine a safe dosage.
b. Phase 2: larger group of
volunteers and patients,
up to 200.
c. Phase 3: confirm findings
by research on a large
patient population with
randomized control (new
, drug vs usual care = gold standard). In this phase, also the efficacy, safety and
side-effects are observed.
3. Marketing authorization (EMA or DFA) and reimbursement
4. Pharmacovigilance (geneesmiddelenbewaking) (=product surveillance) testing long
term safety in real-life patients and monitor side-effects when the drug is on the
market
Market authorization
Licensing and regulatory approval are important parts within the pharmaceutical market.
Important parties who play a big role in licensing and regulatory approvals are:
- EMA: European Medicine Agency They operate on EU-level and observe three
criteria: efficacy, safety and quality and analyse the benefit-risk ration.
- FDA: The U.S. Food and Drug Administration.
- CHMP: EMA’s Committee for Medicinal Products for Human Use: assess applications
submitted by medicine developers and recommends whether or not a medicine
should be granted marketing authorization
- After market authorization, reimbursement criteria and pricing decisions are made.
Type of drugs
- Ethical drugs = prescription drugs = prescription needed
- OTC drugs = without prescription
- Brand drugs = produced and distributed with patent protection
- Generic drugs = without patent protection, opportunity to increase efficiency in
pharmaceutical market
- Me-too drugs = branded drug which is structurally similar to already known drugs, is
a way to get a new patent, innovative problem?
- Orphan drug = for rare diseases, regulatory support and market exclusivity
o Criteria:
Life threatening (chronically debilitating disease)
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 Sophiex123. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $4.87. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
64438 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now