| Is the science that study
relation of physicochemical
properties of drug, dosage
form, & route of administration
on rate and extent of drug
absorption. | BIOPHARMACEUTICS |
| 1 It is the study of the kinetics of
absorption, distribution, metabolism,
and excretion (ADME) of drugs and
their pharmacologic, therapeutic, or
toxic effects in animals and man.
2 drugs given IV go directly into __
3 elimination refers to both __ and __ | 1 PHARMACOKINETICS
2 blood
3 metabolism, excretion |
| 1 DRUG IN BLOOD EXISTS IN EQUILIBRIUM WITH __
2 In equilibrium, the concentration of the drug in blood
different (greater or lesser) than the concentration of
the drug in tissues. This is due to the __
3 The greater the concentration, the __ is the amount of drug transfer.
4 the rate of transfer of a drug from one
compartment to another is __ to
concentration of the drug in the compartment
from which it exits; | 1 DRUG IN TISSUES.
2 physicochemical
properties of the drug.
3 greater
4 proportional |
| Drug remain in stomach: __ (hours)
Drug remain in small intestine : __ (hours) | 1) 2 to 4 hours
2) 4 to 10 hours |
| is the rate and extent of drug absorption from site of administration to the general circulation. | bioavailability |
| refers to a comparison of bioavailabilities of different
formulations, drug products, or batches of
the same drug product. | bioequivalence |
| Bioavailability is used to determine | Pneumonic: ARDR
1 amount of drug absorbed from a formulation or dosage form
2 rate at which the drug was absorbed
3 duration of the drug's presence in biologic fluid or tissue correlated with the patient's response, and
4 relationship between drug blood levels and clinical efficacy and toxicity. |
| DURING PRODUCT DEVELOPMENT STAGE: | Idea to help retain: Compare absorption of drugs .
1 studies bioavailability to compare different
formulations of the drug substance to ascertain which
one allows the most desirable absorption pattern.
2 Later bioavailability studies used to compare the
availability of the drug substance in different
production batches.
3 They may also be used to compare the
availability of the drug substance in
different dosage forms (e.g., tablets,
capsules, elixirs),
4 or in the same dosage form produced by
different (companies) manufacturers. |
| 1 The AUC (Area Under the Curve) of concentration-time curve represent __
2 If similar doses of drug in different formulas produce different AUC values, differences exist in __ | 1 total amount of drug absorbed following administration of a single dose of that drug.
2 extent of absorption between formulations. |
| 1 The smaller AUC, the __ drug absorbed. | 1 lesser |
| 1 The same drug when formulated in different dosage forms have different __ and exhibit different __
2 Furthermore, two identical or equivalent products of same drug in the same dosage strength and in the same dosage form but differing in formulative materials or method of manufacture may vary widely in __ and thus, in __ | 1 bioavailability, clinical effectiveness.
2 bioavailability, clinical effectiveness. |
| FDA USES THE FOLLOWING TERMS TO DEFINE TYPE
OR LEVEL OF EQUIVALENCY BETWEEN DRUG
PRODUCTS. | Pneumonic: P eq, P al, Bio eq, The eq
1 Pharmaceutical equivalents
2 Pharmaceutical alternatives
3 BIOEQUIVALENT DRUG PRODUCTS
4 Therapeutic equivalents |
| are drug products that contain identical amounts of identical active ingredient, that is, the same salt or ester of the same therapeutic moiety, in identical dosage forms but not necessarily containing the same inactive ingredients. | Pharmaceutical equivalents |
| are drug products that contain the identical therapeutic moiety or its precursor but not necessarily in the same amount or dosage form or as the same salt or ester. | Pharmaceutical alternatives |
| ARE PHARMACEUTICAL EQUIVALENTS OR
PHARMACEUTICAL ALTERNATIVES WHOSE RATE
AND EXTENT OF ABSORPTION ARE SIMILAR. | BIOEQUIVALENT DRUG PRODUCTS |
| 1 Some pharmaceutical equivalents or pharmaceutical
alternatives are equivalent in __ but not in __ and yet may be considered bioequivalent.
2 Differences in rate of absorption are intentional and are
reflected in the __, are not essential to the attainment of effective body drug concentrations on chronic use, or are considered medically insignificant for the drug product studied. | 1 extent absorption, rate of absorption
2 labeling |
| used to indicate pharmaceutical equivalents that provide same
therapeutic effect when administered to same
individuals in same dosage regimens. | Therapeutic equivalents |
| 1 Absolute bioequivalency between drug products __ occurs. | 1 rarely
This simply is not expected of products that are made at different times, in different batches, or indeed by different manufacturers. |
| In most studies of bioavailability, the __ is recognized as the established product of the drug and is used as the __ comparative studies. | 1 originally marketed product (brand name drug product)
2 standard for the bioavailability |
| According to the FDA: generic drug is considered
bioequivalent if the rate and extent of absorption do not show a significant difference from that of standard drug when
administered at the same molar dose of the therapeutic ingredient under the same experimental conditions.
True or False | True |
| Under the 1984 act, to gain FDA approval a generic drug product must have these characteristics: | Pneumonics: TIT
1 The same active ingredients as the standard drug .
2 Identical strength, dosage form, and route
of administration
3 The same indications and precautions for use |
| 1 The same batch-to-batch requirements for identity,
strength, purity, and quality
2 If a standard manufacturer reformulates an FDA- approved
product, the subsequent formulation must meet the same
__ that are required of generic
manufacturers of that product | 1 Bioequivalency
2 bioequivalency standards |
