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18 Cards in this Set
- Front
- Back
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What is biopharmaceutics? |
Biophamaceutics is the study of the interrelationship of the physicochemical properties of the drug and the drug product based on the biological performance of the drug. |
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What is bioavailability? |
Bioavailability is a description of the rate and extent of which a drug when administered in a pharmaceutical dosage form becomes available at the site of pharmacological effect |
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Gie five reasons why bioavailability is important to pharamceutical scientists |
1. Key performance indicator of efficiency of formulation 2. Variance = poor clinical responses in certain individuals 3. Expertise in pharmaceutical science 4. Understanding key concepts empowers to solve important OTC issues 5. Important when choosing formulations in key clinical settings |
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Where is bioavailability initially measured? |
in-vivo |
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What is pharmacokinetics? |
- What the body does to the drug - Assumes correlation of systemic drug conc. action - Easy to measure |
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What is pharmacodynamics? |
- What the drug does to the body
- Relevance of other parameters has to be ruled out - Difficult to measure |
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What four things does a plasma concentration-time curve show the net effects of? |
1. Drug release 2. Stability 3. Presystemic metabolism 4. Adsorption |
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What six pieces information does a pK study provide? |
1. Dosing level 2. Duration 3. Therapeutic window 4. Dosing regimen 5. Accumulation effects 6. Bioavailability |
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What is Cpmax? |
Maximum concentration of drug |
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What is Tmax? |
Time to maximum concentration of drug |
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What is AUC? |
Area under the curve |
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What is absolute bioavailability? |
Absolute bioavailability, F , is the fraction of an administered dose which actually reaches the systemic circulation |
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How do you work out absolute bioavailability? |
F = AUC(ev)/AUC(iv). Can be divided by dose if inequivalent. |
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What is relative bioavailability? |
Relative bioavailability refers to the availability of a drug product as compared to another dosage form or product of the same drug given in the same dose. |
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How do you work out relative bioavailability? |
RB = AUC(a)/AUC(b), where A is test product and B is reference standard. |
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State eight physiological factors that influence bioavailability |
1. Variations in absorption power 2. Variations in pH of GI fluid 3. Gastric emptying rate 4. Intestinal motility 5. Perfusion of GI tract 6. Presystemic and first pass metabolism 7. Age, sex, weight 8. Disease states |
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What is bioequivalence? |
Bioequivalent drug products are pharmaceutical equivalents that have similar bioavailability (i.e. are not significantly different with respect to rate and extent of absorption) when given in the same molar dose and studied under similar experimental conditions. |
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Name seven different ways that bioequivalence can be determined |
1. in-vivo PK tests in humans. 2. in-vitro test correlated with an in-vivo PK test in humans. 3. in-vivo test in animals correlated to an in-vivo human PK test. 4. in-vivo human test using urinary metabolites. 5. in-vivo test in humans using pharmacodynamic measure 6. Comparing clinical trial date (not recommended) 7. in-vitro test without a known IVIVC |
