Bioequivalence 1 Flashcards
What are generic drug products?
copies of brand-name drugs with same active ingredients and for the same intended therapeutic use as innovator product
-look different from innovator product
-cheaper
Describe the regulatory origins of bioequivalence in the 1950s.
increased recognition that different products with same amount active ingredient –> different therapeutic response
increasing efforts to define BA and BE and procedures for their assessment
bioanalytical capacity growing
-most differences in product performance due to dissimilar Cp vs t
-primarily impaired absorption and F
Prior to 1962, how were drugs approved?
were approved for safety only
-1938: Federal Food, Drug, and Cosmetic Act
-1951: prescription and OTC
Explain the thalidomide tragedy.
thalidomide used to cure morning sickness in late 1950s
withdrawn from market in 1961 after being found to be a cause of birth defects
Describe the regulatory origins of bioequivalence in 1962.
amendments to the Federal Food, Drug, and Cosmetic Act
-added a proof-of-efficacy requirement to new drug approval
-generics had to meet safety, efficacy and BE criteria
-after 1962, generic companies would not spend time and money doing clinical trials to get to market
What is the Hatch-Waxman Act?
Drug Price Competition and Patent Term Restoration Act
-established in 1984
-established ANDA
What is the ANDA?
approval of generics of drugs already safe and effective
only have to meet pharmaceutical equivalence and BE
What are the critical issues in pharmacy associated with bioequivalence?
increased enhancement in availability of generics
-~70% prescriptions substituted
-decreased cost of health care
consequence?
-you play a key role in product selection decisions
-expected to know: whats best for pt, what is in pipeline
What is the definition of pharmaceutical equivalents?
a new drug that, in comparison with another drug, contains identical amounts of the identical medical ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients
What is the US FDA definition of bioavailability?
rate and extent to which the active ingredient or moiety is absorbed from a drug product and becomes available at the site of action
What is the Canada TPD definition of bioavailability?
rate and extent of absorption of drug into the systemic circulation
What is the US FDA definition of bioequivalence?
the absence of a significant difference in rate and extent to which active ingredient or moiety in pharmaceutical equivalents or alternatives becomes available at site of drug action when administered at same molar dose under similar conditions in an appropriately designed study
What is the Canada TPD definition of bioequivalence?
high degree of similarity in the bioavailabilites of two pharmaceutical products (of the same active ingredient) from the same molar dose, that is unlikely to produce clinically significant relevant differences in therapeutic effects, or adverse effects, or both
When a test product is claimed bioequivalent to the reference product, what is assumed about the product?
therapeutically equivalent and, hence, interchangeable wit the reference product
What are the factors modifying BA that are related to dosage form?
physicochemical properties of drug
-particle size, crystalline structure, polymorphic form, degree of hydration, salt form, ester form
formulation and manufacturing variables
-amount of disintegrant/lubricant, coatings, nature of diluent, compression force
