Drug Development Process / Manufacturing Practices Flashcards
Describe the main steps of the drug development process
- New chemical entity
- Preclinical studies
- Investigational new drug application
- Both Clinical trials (Phase I-III) and Preclinical studies (agiain)
- New Drug Application
- Postmarketing
List and describe FDA’s responsibilities
Protecting and advancing the public health
FDA’s definition for ‘New Drug’
An active ingredient that has never been marketing in the USA in some form
What does FDA stand for
Food and Drug Administration
Describe Clinical Phase 1
- 20-100 pt
- Up to 1 year
- Purpose: safety
- 70% drugs are successfully tested
Describe Clinical Phase 2
- 100-500 pt
- Several months to 2 years
- Purpose: short-term safety, but mainly effectiveness
- 33% drugs are successfully tested
Describe Clinical Phase 3
- 1000-5000 pt
- 1-4 years
- Safety, effectiveness, dosage
- 25-30% drugs are successfully tested
What is manufacturing?
Large scale, well-defined products produced by pharma companies
What is compounding?
Small scale, pt-specific produced in compounding pharmacies
What are some reasons why there has been an increase in compounding pharmacies?
- Dose, strength, dosage form, allergy requirements
- Collaborate to deliver innovative products
- Veterinary applications
- Drugs reported in literature but not yet manufactured
What is a container?
Holds and may be in direct contact w/ article
What is an immediate container?
In contact w/ article at all times
What is the pro of glass containers?
- Resist deterioration
- Water permeability
- Amount of alkali in glass
What is Type I, II, III glass containers?
Decreasing resistance; used for parenteral products
What is Type NP glass container?
Least resistance and used for other products
What is the pro of plastic containers?
- Reduced weight and impact resistant
- Versatility in design
- Consumer preference in squeeze bottles
- Popularity of blister packaging
What are the cons of plastic containers?
- Permeability to air and moisture
- Leaching into internal contents
- Sorption of drug to container
- Transmission of light thru container
- Alteration of container during storage
What is a child resistant container?
Significantly difficult for children under 5yo to open
Who are exempted from the child resistant containers?
Seniors and arthritis pt
What happens if an OTC is exempt from child resistant tops?
They just have to be labeled that package is not child resistant
What are the issues with compliance packaging?
- Misunderstanding of dosing schedule
- Confusion due to too many Rx
- Forgetfulness
- Feeling of well-being
What are the manufacturer’s labels?
Label on immediate container (lot, name, dosage, etc)
What are the prescription labels?
Ones placed by pharmacist on dispensed medication
What are the OTC labels?
Standardized format set by FDA which has bar code and drug facts box; has to be understood especially by seniors
