DR and ARMD Flashcards
_________________ means the RATE and EXTENT to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action
Bioavailability
HIGHLY SIMILAR TO THE REFERENCE PRODUCT notwithstanding minor differences in clinically inactive components, and there are NO CLINICALLY MEANINGFUL DIFFERENCES between the biological product and the reference product in terms of the safety, purity, and potency of the product.
Biosimilar or biosimilarity
Drug products that contain the same therapeutic moiety but as DIFFERENT SALTS, ESTERS, OR COMPLEXES.
Pharmaceutical alternatives
Different dosage forms and strengths within a product line by a single manufac- turer are pharmaceutical alternatives (eg, an extended- release dosage form and a standard immediate-release dosage form of the same active ingredient)
The FDA currently considers a tablet and capsule containing the same active ingredient in the same dosage strength as pharmaceutical alternatives.
Drug products in IDENTICAL DOSAGE FORMS that contain the same active ingredient(s), but different amounts of inactive drug that is, the same salt or ester, are of the same dosage form, use the same route of administra- tion, and are identical in strength or concentration
Pharmaceutical equivalents
Pharmaceutically equivalent drug products are formulated to contain the same amount of active ingredient in the same dosage form and to meet the same or compendial or other applicable standards (ie, strength, quality, purity, and identity), but they may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling.
The process of dispensing a pharmaceutical alternative for the prescribed drug product.
Pharmaceutical substitution
For example, ampicillin suspension is dispensed in place of ampicillin capsules, or tetracycline hydrochloride is dispensed in place of tetracycline phosphate. Pharmaceutical substitution generally requires the physician’s approval.
Drug products containing different active ingredients that are indicated for the same therapeutic or clinical objectives.
Therapeutic alternatives
Active ingredients in therapeutic alternatives are from the same pharmacologic class, for example, ibuprofen is given instead of aspirin; cimetidine may be given instead of ranitidine.
Therapeutic equivalents:
Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the con- ditions specified in the labeling.
The availability of the absorption product compared to the recognized standard
Relative bioavailiabilty
AB=F
Absolute bioavailability = fraction of dose absorbed
The macula is located behind the:
Pupil
TorF: low concentration of cones facilitate clear and crisp central vision
False. High concentration of cones facilitate clear and crisp central vision
The initial stage of DR is called
Nonproliferative DR (NPDR; previously termed “background” retinopathy)
Advanced stage of diabetic retinopathy can be termed:
Proliterative DR
TorF: DME occurs at the end of the disease
False:
Diabetic macular edema (DME) or diabetic macular ischemia can occur at any stage of the disease
Chronic intracellular hyperglycemia triggers a cascade of biochemical
mechanisms at the cellular level that drive the disease process incl:
Aldose reductase (sorbitol) and protein kinase C (PKC) pathways
Renin‐angiotensin system (RAS)
Oxidative stress (OS)
Accumulation of advanced glycation end products (AGE)
Release of inflammatory mediators and vascular endothelial growth factor (VEGF) that damage ophthalmic vascular endothelial cells.
tiny swellings, or microaneurysms, in the retinal capillary walls:
Mild NPDR
