PTCB MTM Exam Preparation

serum calcium

8.6-10.3

glucose

80-130

chloride levels

96-106

BD

active ingredient and dosage forms with DOCUMENTED bioequivalence problems

AP

injectable aqueous / IV solutions

AT

topical products

BT

topical products that are not bioequivalent

creatinine levels

women: 0.74-1.35mg/dL men: 0.59-1.04mg/dL

TSH (thyroid stimulating hormone)

0.4-4.0, with 4.0-5.0 being high, and higher than 5.0 likely representing hypothyroidism

magnesium levels

1.7-2-2

sodium levels

135-145

CO2 levels

23-29

potassium levels

3.6-5.2

BUN (blood urea nitrogen) levels

7-20 mg/dL (2.5-7.1 mmol/L)

BC

Extended-release dosage forms (capsules, injectables and tablets)

AO

Injectable oil solutions

Therapeutic equivalence

The FDA criteria require that they: (1) are approved drugs shown to be safe and effective; expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling (2) are pharmaceutical equivalents which (a) contain identical amounts of the same active ingredient in the same dosage form and route of administration, and (b) meet required standards of strength, quality, purity, and identity (3) are bioequivalent - either the drugs do not present a known or potential bioequivalence problem and meet an acceptable in vitro standard, or may present a known or potential bioequivalencce problem but it is within acceptable bioequivalence standards (4) have adequate labeling (5) are manufactured in compliance with current Good Manufacturing Practice regulations

The Orange Book

The FDA's list of therapeutic drug equivalence-drugs containing the same active ingredients

BN

aerosol nebulizer delivery systems

pharmaceutical alternatives

are different salts, esters, or complexes (e.g. tetracycline hydrochloride and tetracycline phosphate complex) have different dosage forms (e.g. capsules vs. tablets) or strengths data are generally not available for FDA to make the determination of tablet to capsule

Pharmaceutical equivalent

contain the same active ingredient(s) have the same dosage form and route of administration are identical in strength or concentration

AA

conventional dosage forms

BE

delayed-release oral dosage forms

bioequivalence

determined based on the drug's pharmacokinetics the rate and extent of absorption of the test drug (usually a generic) are not significantly different from those of the reference drug (brand) when they are administered at the same molar dose under similar conditions; in either a single dose or multiple doses OR the extent of absorption of the test drug does not differ significantly from that of the reference drug the rate of absorption may differ, but this is intentional, is reflected in the product labeling, is not essential to the attainment of effective body drug concentrations during chronic use, and is considered medically insignificant for the drug (e.g. a generic may need to be taken twice daily but with regular use, its effects would be equivalent)

"A" rating

drugs that are therapeutically equivalent to the reference drug, with no known bioequivalence problems

A1C

glycosylated hemoglobin normal <5.7% prediabetes = 5.7% - 6.4% diabetes >6.5% A1C = BG 7=152 8-183 9=212 10=240

INR

international normalized ratio <1.1 is normal for healthy people 2.0-3.0 is effective therapeutic range for warfarin; may need to be higher for L-VAT patients

biosimilars

not "generic copies" because they are biologic products derived from a different cell line. According to the FDA: subsequent versions of an innovative biopharmaceutical product highly similar to the already FDA-approved biological "reference point" have been shown to have no clinically meaningful differences in safety, purity, and potency from the reference product (e.g. Lantus and Semglee)

"B" rating

not therapeutically equivalent to other pharmaceutical products; actual or potential bioequivalence problems have not been resolved

BP

potential bioequivalence problems

BX

products for which the data are insufficient to determine therapeutic equivalence

BS

products shown by the FDA to have deficient standards

bioavailability

refers to the rate and extent to which an active ingredient is absorbed after administration and becomes available at the drug's site of acction

B*

requires FDA investigation to review equivalence

AN

solutions and powders for aerosolization

"AB" rating

therapeutically equivalent to each other; known or potential bioequivalence problems may exist but have been found to meet standards for bioequivalence