2- states of drug production

Question 1

what is the cost of developing a new drug? what is included in this cost?

Answer 1

it costs $1.3 billion and takes into account successes and failures

Question 2

what is the typical project progression? list the 5 main steps and how long they take

Answer 2

• discovery→ 1-3 years
• development → 1-2 years
• clinical trials (test on humans) → 1-5 years
• fda approval → 6 months to 1.5 years
• market → unlimited

Question 3

how long does a new molecular entity take in total?

Answer 3

12 years (average)

Question 4

what is a drug candidate and what stage is it identified at?

Answer 4

• drug candidate is a molecular entity that has potential to be drug substance
• identified at the discovery stage

Question 5

what is an IND, and what stage is it found in?

Answer 5

• investigational new drug

- found in the development stage

Question 6

what 3 data is included in an IND?

Answer 6

• animal pharmacology and toxicity data
• manufacturing information
• clinical protocols and investigator information

Question 7

what is an NDA, and what stage is it found in?

Answer 7

• new drug application

- found in the clinical stage

Question 8

what 4 things are found in the NDA?

Answer 8

• safety of drug
• efficacy of drug
• appropriate labelling
• manufacturing methods are finalized

Question 9

what is an ANDA? who requests these, and what is required?

Answer 9

• abbreviated new drug application
• application made to the FDA to enter market for a generic drug
• generic company must show that they’re making same identity, dose, formulation, route of administration, performance characteristics, intended use

Question 10

the first step is idea or discovery- list the time period, major goals, end product?

Answer 10

• time period: 1 to 3 years
• major goals: start with an idea and discover a new molecular entity (drug candidate)
• end product: drug candidate

Question 11

the second step is development- list the time period, major goals, end product?

Answer 11

• time period: 1 to 2 years
• major goals: turn drug candidate into sellable product (investigational new drug)
• end product: investigational new drug

Question 12

the third step is clinical trials- list the time period, major goals, end product?

Answer 12

• time period: 1-5 years
• major goals: test IND for safety. establish safe limits for dosing. test for efficacy, establish dosing, test for rare side effects
• end product: new drug application

Question 13

the fourth step is FDA approval- list the time period, major goals, end product?

Answer 13

• time period: 6 months to 1.5 years
• major goals: review data from clinical trials to ensure testing was done properly, verify that data shows clear benefit which outweighs the risks
• end product: market approval

Question 14

the fifth step is market- list the time period, major goals, end product?

Answer 14

• time: unlimited
• major goals: make money. continue safety testing. identify very rare side effects, find new indications
• end product: money