Introduction to Drug Development Flashcards
(25 cards)
How long does the drug discovery pipeline take?
It takes 10 - 15 years.
what is the target of drug development?
produce the drug in a marketable form and gain regulatory permission to use it for target indication as quickly as possible.
What phases are involved with the discovery pipeline?
Discovery Phase
Development Phase
What are the stages within the discovery phase?
Target Selection
Target Validation
Lead Generation
What are the stages within the development phase?
Lead Optimisation and Evaluation
Clinical Trials
What does Target Selection involve?
Literature Search.
Looking for pharmacological targets for a disease.
What does Target Validation involve?
Test hypothesis.
Validate the target.
= Double checks everything is working.
What does Lead Generation involve?
Identify lead compounds (to allow a high throughput).
Improve physiochemical properties.
= Ensures the drug is soluble.
What does Lead Optimasation and Evaluation involve?
Optimise compounds to prepare for clinical testing.
Efficacy / Selectivity / Pharmacokinetics / Toxicology
= Ensures there is no irritation in the skin.
What does Clinical Trials involve?
3 major phases.
Phase 1 - Tolerability / Safety / Pharmacokinetics.
Phase 2 - Dosage / Efficacy in patients.
Phase 3 - Large scale pivotal studies.
Where does ideas for drug discovery come from?
Accidental.
Existing treatment with unexpected effect.
New information on disease processes.
New technologies.
What is the main aim of preclinical research?
Is it safe for humans?
Estimate dose in humans.
what are the stages and decison points of pre-clinical trials?
What are the 2 types of pre - clinical research?
In - Vitro = Outside a living organism.
In - Vivo = Inside a living organism.
What is harmonisation of standards?
This is when every result you get is standardised and therefore, can be applied to everyone too.
What are the 3 features used in quality assurance to ensure high quality and integrity of research?
GLP = Good Laboratory Practice
GMP = Good Manufacturing Practice
GCP = Good Clinical Practice
What occurs in regulatory approval?
All data is reviewed from pre - clinical to phase 3.
This allows proposed labelling and patient information sheets to be filled in.
What is the life - cycle management in the post approval stage?
Maximising value of a drug through commercial and development life.
View any other competition from generic drugs.
The patency to sell lasts at least 20 years.
What are some challenges with drug development?
Rising cost of drug development.
- Clinical Trial Design
- Decline in Targets
- Complex regulatory requirement
Public perception of ‘unmet needs’.
What are the partnerships in drug development?
See hand drawn diagram
List some reasons for attrition.
Lack of efficacy
Safety
Pharmacokinetics
Formulation
Bioavailability
Commercial
Cost of goods
What is the most common reason for attrition in the pre - clinical phase?
Toxicology.
What is the most common reason for attrition in the phase 1?
Safety.
What is the most common reason for attrition in the phase 2/3?
Efficacy.
