Cmax (pharmacology): Difference between revisions
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{{DISPLAYTITLE:C<sub>max</sub> (pharmacology)}} |
{{DISPLAYTITLE:''C''<sub>max</sub> (pharmacology)}} |
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{{Short description|Peak concentration of a drug in a body compartment}} |
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| ⚫ | '''C<sub>max</sub>''' is |
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{{ou|Cmax (disambiguation)}} |
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| ⚫ | {{math|'''''C''<sub>max</sub>'''}} is the maximum (or peak) [[Serum (blood)|serum]] [[concentration (chemistry)|concentration]] that a drug achieves in a specified [[compartment (pharmacokinetics)|compartment]] or test area of the body after the drug has been administered and before the administration of a second dose.<ref name="isbn0-7817-3762-1">{{cite book | veditors = Stitzel RE, Craig CF | author = Tracy TS | chapter = Pharmacokinetics | title = Modern pharmacology with clinical applications | publisher = Lippincott Williams & Wilkins | location = Hagerstwon, MD | year = 2004 | page = 49 | isbn = 0-7817-3762-1 }}</ref> It is a standard measurement in [[pharmacokinetic]]s. |
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T<sub>max</sub> is the term used in [[pharmacokinetic]]s to describe the time at which the C<sub>max</sub> is observed. <ref> http://www.lexjansen.com/phuse/2006/st/st03.pdf </ref> |
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==Description== |
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After an intravenous administration, C<sub>max</sub> and T<sub>max</sub> are closely dependent on the experimental protocol, since the concentrations are always decreasing after the dose. But after oral administration,C<sub>max</sub> and T<sub>max</sub> are dependent on the extent, and the rate of drug absorption and the disposition profile of the drug. They could be used to characterize the propertied of different formulations in the same subject. <ref> ting says </ref> |
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{{math|''C''<sub>max</sub>}} is the opposite of {{math|[[Cmin|''C''<sub>min</sub>]]}}, which is the minimum (or trough) concentration that a drug achieves after dosing. The related pharmacokinetic parameter {{math|'''''t''<sub>max</sub>'''}} is the time at which the {{math|''C''<sub>max</sub>}} is observed.<ref>{{cite web | url = http://www.lexjansen.com/phuse/2006/st/st03.pdf | title = Statistics and Pharmacokinetics in Clinical Pharmacology Studies | author = Amy Newlands | url-status = dead | archive-url = https://web.archive.org/web/20131113232412/http://www.lexjansen.com/phuse/2006/st/st03.pdf | archive-date = 2013-11-13 }}</ref> |
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| ⚫ | Short term drug [[adverse drug reaction|side effect]]s are most likely to occur at or near the C<sub>max</sub> whereas the therapeutic effect of drug with sustained duration of action usually occurs at concentrations slightly above the C<sub>min</sub>. |
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After an intravenous administration, {{math|''C''<sub>max</sub>}} and {{math|''t''<sub>max</sub>}} are closely dependent on the experimental protocol, since the concentrations are always decreasing after the dose. But after oral administration, {{math|''C''<sub>max</sub>}} and {{math|''t''<sub>max</sub>}} are dependent on the extent, and the rate of drug absorption and the disposition profile of the drug. They could be used to characterize the properties of different formulations in the same subject.<ref name="pmid12708608">{{cite journal | vauthors = Urso R, Blardi P, Giorgi G | title = A short introduction to pharmacokinetics | journal = Eur Rev Med Pharmacol Sci | volume = 6 | issue = 2-3 | pages = 33–44 |date=March 2002 | pmid = 12708608 }}</ref> |
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| ⚫ | Short term drug [[adverse drug reaction|side effect]]s are most likely to occur at or near the {{math|''C''<sub>max</sub>}}, whereas the therapeutic effect of drug with sustained duration of action usually occurs at concentrations slightly above the {{math|''C''<sub>min</sub>}}.{{Citation needed|date=September 2019}} |
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The {{math|''C''<sub>max</sub>}} is often measured in an effort to show [[bioequivalence]] (BE) between a generic and innovator drug product.<ref name="pmid16240706">{{cite journal | vauthors = Midha KK, Rawson MJ, Hubbard JW | title = The bioequivalence of highly variable drugs and drug products | journal = Int J Clin Pharmacol Ther | volume = 43 | issue = 10 | pages = 485–98 |date=October 2005 | pmid = 16240706 | doi = 10.5414/cpp43485}}</ref> According to the FDA, drug quality [[bioavailability]] (BA) and BE rely on pharmacokinetic measurements such as [[Area under the curve (pharmacokinetics)|AUC]] and {{math|''C''<sub>max</sub>}} that are reflective of systemic exposure.<ref>{{cite web|title=Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations|url=https://www.fda.gov/media/88254/download|publisher=FDA|access-date=18 February 2021}}</ref> |
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[[Category:Pharmacokinetics]] |
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==See also== |
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* [[Cavg (pharmacology)|C<sub>avg</sub> (pharmacology)]] |
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* [[Area under the curve (pharmacokinetics)]] |
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[[Category:Pharmacokinetic metrics]] |
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{{pharmacology-stub}} |
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Latest revision as of 16:17, 26 September 2024
Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose.[1] It is a standard measurement in pharmacokinetics.
Description
[edit]Cmax is the opposite of Cmin, which is the minimum (or trough) concentration that a drug achieves after dosing. The related pharmacokinetic parameter tmax is the time at which the Cmax is observed.[2]
After an intravenous administration, Cmax and tmax are closely dependent on the experimental protocol, since the concentrations are always decreasing after the dose. But after oral administration, Cmax and tmax are dependent on the extent, and the rate of drug absorption and the disposition profile of the drug. They could be used to characterize the properties of different formulations in the same subject.[3]
Short term drug side effects are most likely to occur at or near the Cmax, whereas the therapeutic effect of drug with sustained duration of action usually occurs at concentrations slightly above the Cmin.[citation needed]
The Cmax is often measured in an effort to show bioequivalence (BE) between a generic and innovator drug product.[4] According to the FDA, drug quality bioavailability (BA) and BE rely on pharmacokinetic measurements such as AUC and Cmax that are reflective of systemic exposure.[5]
See also
[edit]References
[edit]- ^ Tracy TS (2004). "Pharmacokinetics". In Stitzel RE, Craig CF (eds.). Modern pharmacology with clinical applications. Hagerstwon, MD: Lippincott Williams & Wilkins. p. 49. ISBN 0-7817-3762-1.
- ^ Amy Newlands. "Statistics and Pharmacokinetics in Clinical Pharmacology Studies" (PDF). Archived from the original (PDF) on 2013-11-13.
- ^ Urso R, Blardi P, Giorgi G (March 2002). "A short introduction to pharmacokinetics". Eur Rev Med Pharmacol Sci. 6 (2–3): 33–44. PMID 12708608.
- ^ Midha KK, Rawson MJ, Hubbard JW (October 2005). "The bioequivalence of highly variable drugs and drug products". Int J Clin Pharmacol Ther. 43 (10): 485–98. doi:10.5414/cpp43485. PMID 16240706.
- ^ "Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations". FDA. Retrieved 18 February 2021.