Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Close this folder2. Product assessment and registration
View the documentGuidelines for the assessment of herbal medicines1,2
Open this folder and view contentsStability of drug dosage forms1
Open this folder and view contentsGuidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
Close this folderMultisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability1
View the documentIntroduction
View the documentGlossary
Open this folder and view contentsPart One. Regulatory assessment of interchangeable multisource pharmaceutical products
Open this folder and view contentsPart Two. Equivalence studies needed for marketing authorization
Open this folder and view contentsPart Three. Tests for equivalence
View the documentPart Four. In vitro dissolution tests in product development and quality control
View the documentPart Five. Clinically important variations in bioavailability leading to non-approval of the product
View the documentPart Six. Studies needed to support new post-marketing manufacturing conditions
View the documentPart Seven. Choice of reference product
View the documentAuthors
View the documentReferences
View the documentAppendix 1. Examples of national requirements for in vivo equivalence studies for drugs included in the WHO Model List of Essential Drugs (Canada, Germany and the USA, December 1994)
View the documentAppendix 2. Explanation of symbols used in the design of bioequivalence studies in humans, and commonly used pharmacokinetic abbreviations
View the documentAppendix 3. Technical aspects of bioequivalence statistics
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 

Appendix 2. Explanation of symbols used in the design of bioequivalence studies in humans, and commonly used pharmacokinetic abbreviations

Cmax

The observed maximum or peak concentration of drug (or metabolite) in plasma, serum or whole blood.

Cmin

The minimum plasma concentration.

Cmax-ratio

The ratio of the geometric means of the test and reference Cmax values.

Cav

The average plasma concentration.

AUC

The area under the curve for drug (or metabolite) concentration in plasma (or serum or whole blood) against time. The value of AUC may be that for a specific period, e.g. AUC from zero to 12 hours is shown as AUC12.

AUCt

AUC from zero to the last quantifiable concentration.

AUC

AUC from zero to infinity, obtained by extrapolation.

AUCτ

AUC over one dosing interval (τ) under steady-state conditions.

AUC-ratio

The ratio of the geometric means of the test and reference AUC values.

Ae

The cumulative urinary recovery of parent drug (or metabolite). The value of Ae may be that for a specific period, e.g. Ae from zero to 12 hours is shown as Ae12.

Aet

Ae from zero to the last quantifiable concentration.

Ae

Ae from zero to infinite time, obtained by extrapolation.

Aeτ

Ae over one dosing interval under steady-state conditions.

dAe/dt

The rate of urinary excretion of parent drug (or metabolite).

tmax

The time after administration of the drug at which Cmax is observed.

tmax-diff

The difference between the arithmetic means of the test and reference tmax values.

t½

The plasma (serum, whole blood) half-life.

MRT

The mean residence time.

µT

Average bioavailability of the test product.

µR

Average bioavailability of the reference product.

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