Topic 17 - Drug Development Flashcards
New Drug
Any agent that has not been generally recognized as safe and effective under the conditions recommended
Issues with a New Drug (2)
- New formulation needs to be examined for safety and efficacy
- Different methods of manufacturing or different excipients can alter the therapeutic efficacy of a drug
Desired features of a ‘goal drug’ (8)
- Produce desired effect
- Administered by desireable route
- Minimum dosing and dosing frequency
- Optimal onset and duration of activity
- Efficient and complete elim
- Easily produced at low $
- Physically and chemically stable
- Safe!
What was the issue with thalidomide in the early 60s?
Associated with birth defects, and became banned in most countries
What are preclinical studies used for? (3)
- Determining chemical and physical properties
- Determining biological properties (pharmacology, ADME, toxicology)
- Preformulation
“IND”
Investigational New Dryg
“DEL”
Drug Establishment Licenses (required for fabrication, packaging/labelling, distribution, importation, wholesale)
T/F: The order of the clinical trials phases are as follows:
- Efficacy
- Shift to safety
- Combination
F: 1 & 2 are switched -
- Safety
- Shift to efficacy
- Safety and efficacy
Phase 1 of clinical trials
Involves 20-100 healthy volunteers. Initial dose is low, becomes larger until evidence drug action is observed. Determine metabolism and pharmacological action of drug in humans.
Phase 2 of clinical trials
Determine efficacy of drug noted in healthy volunteers. Pt suffering from disease are treated in limited numbers. More ADME data.
Phase 3 of clinical trials
Several hundred to thousane pt. Private practitioners of diff backgrounds and experience brought in by more experienced clinicians. Practitioners report to principal investigator who relays info and their evaluation to HPFB or FDA.
T/F: Only ~8% of the drugs that successfully complete Phase 1 will complete Phase 3
T
Post-marketing
Systematic and comprehensive monitoring of the patterns of use and beneficial or harmful effects of drug as used in medical practice and by the consumer
Why are Good Manufacturing Practices (GMPs) important? (6)
- Government req
- Quality of product
- Reduce rejects/recalls
- Satisfied customers
- Maintain manufacturing consistency
- Company image and reputation
What are the 5 production goals of a drug?
- Safety
- Identity
- Strength
- Purity
- Quality
