L2 Flashcards
What part of R & D is innovation?
New product development
What is drug research?
discovery & design
What are the 5 qs a company asks when coming up with a new idea?
- How valuable is this new idea?
- Does the technology exist to help deliver this new idea into a product?
- Do we have this technology?
- Do we have the organizational architecture? (managerial) Do we have the necessary procedures to run this development?
- Can this group live with the uncertainty that this new idea will bring to the company?
What power doess the boss have?
Referent
Reward
Expert
Legitimate
What power do the scientists have?
Expert
What does the NPV rely on?
Quality of the drug
What ae the 6 stages of drug discovery & design
- exploratory
- Assay development
- Screening
- Hit-to-lead
- Early lead optimization
- late lead optimization
What is NPV of each molecule discovered determined by?
by calculating potential market of drug
What are 4 approaches in drug discovery?
Phenotypic based
Target based
Molecular drug design
Repurposing
What type of discovery is cheaper phenotypic or target based?
Target based
What is a down fall of target based discovery?
Do not show adverse effects of drug
need both phenotypic & target based
Define attrition?
Removal of molecules from a study to find desired target
What is the generic process of innovation?
stage gate process
What are 3 phases of drug development?
Early
Late
Milestone
What are milestones in drug development?
First-in-human trail
end of phase 2
plant transfer
submission for marketing authorization
Launch
What is the preclinical stage?
when a product is tested on animals and is well tolerated
What is the clinical phase?
product is developed for launching
What is phase 1?
take few mg of drug from pre clinical trails and introduced into a formulation & administered to a healthy human volunteer
What is phase 1 called?
Human pharmacology trails (volunteers)
What is phase 2 called?
Therapeutic exploratory (patients)
What is phase 3 called?
Therapeutic confirmatory
When are patients used in phase 1?
Serious diseases
What does phase 1 look at?
Safety of drug
Pharmacokinetics
What does phase 2 look at?
Therapeutic exploration of dosage in patients
Why are human pharmacology studies repeated throughout phases?
If a patient is taking other drugs so need to identify if that drug affects the PKa of our drug
Drug is changed from tablet to solution
Finer particle product is discovered
What is a reason for decline?
IP (generics)
Better drug is invented
Resistance
S/Es
