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Bioavailability and
 Bioequivalence




        Anas Bahnassi PhD RPh
Lecture Objectives
Upon the completion of this lecture the student should be able to:
• Define terms bioavailability, absolute bioavailability, comparative bioavailability,
  bioequivalence, therapeutic equivalence, pharmaceutically equivalent products and
  pharmaceutical alternatives




                                                                                             Anas Bahnassi PhD 2011
• Explain the difference between bioequivalence and therapeutic equivalence and
  describe whether bioequivalence will, in all cases, lead to therapeutic equivalence
• Calculate absolute and relative bioavailability
• Explain the manner in which parameters reflecting rate and extent of absorption are
  used to determine bioequivalence between two formulations; use equations to
  calculate these parameters
• Explain the first-pass effect and its influence on bioavailability of a drug
• Perform calculations to assess bioequivalency by the method employed by the US
  Food and Drug Administration (FDA)
• Explain the FDA rating system for bioequivalency.
                                                                                         2
Bioavailability
                          Definitions




    The relative amount of an                      The rate and extent to which the active
administered dose that reaches the                   ingredient or therapeutic moiety is
 general circulation and the rate at               absorbed from a product and becomes
         which this occurs                           available at the site of drug action




                                   Anas Bahnassi PhD 2011                            3
Pharmaceutical
                                                  Therapeutic
            or Chemical
                                                  Equivalence
            Equivalence

 Means that two or more                                         Two or
  drug products contain                                  more chemically or
  equal amounts of the                                    pharmaceutically
   same therapeutically
                                                              equivalent
   active ingredients in
 identical dosage forms,
                                                         products essentially
  and that these dosage                               produce the same efficacy
      forms meet the                                  and/or toxicity in the same
  requirements such as                                    individuals when
purity, content uniformity                               administered in an
and disintegration time as                                     identical
established by the United                                       dosage
   States Pharmacopeia                                         regimen.
     and/or National
         Formulary.
                             Anas Bahnassi PhD 2011                            4
Bioequivalence
                                                    Compare
                                                 Bioequivalence
                                                       and
        Two or more chemically or                  Therapeutic
   pharmaceutically equivalent products            Equivalence
    produce comparable bioavailability
   characteristics in any individual when
administered in equivalent dosage regimen
  (parameters compared include the area
under the plasma concentration versus time
curve (AUC) from time zero to infinity AUC ,
 maximum plasma concentration and the
       time of peak concentration).



                        Anas Bahnassi PhD 2011                    5
Bioavailability



 Absolute                                       Relative


                                                Comparing bioavailability parameters
                                                  derived from plasma or urine data
                                                between two different dosage forms or
  Comparing AUC or total Xu of                   two different extravascular routes of
 extravascular administration to                            administration
   intravascular administration


                           Anas Bahnassi PhD 2011                                  6
im




Anas Bahnassi PhD 2011        7
Absolute
       Bioavailability


     (������������������)������������������������������������������������������������������������������                           (������������ )������������������������������������������������������������������������������
      ������������������������������������������������������������������������������������������������������                          ������������������������������������������������������������������������������������������������������
F=              (������������������)������������                                 F=              (������������ )������������
                 ������������������������������������                                               ������������������������������������




                   (������������������)������������������������        ������������������������������������                    (������������ )������������������������         ������������������������������������
              F=
                    (������������������)������������
                                      ×
                                          ������������������������������������������������
                                                                         F=                  ×
                                                                            (������������ )������������           ������������������������������������������������

                                               Anas Bahnassi PhD 2011                                                8
Relative
         Bioavailability



  (������������������)������������������������        ������������������������������������                            (������������ )������������������������������������          ������������������������������������������������������������������������
F=                   ×                                         F=                          ×
   (������������������)������������          ������������������������������������������������                        (������������ )������������������������������������������������        ������������������������������������������������������������




                                            Anas Bahnassi PhD 2011                                                9
(������������������)������������������������������������������        ������������������������������������������������������������������������
                                                 F=                              ×
                                                      (������������������)������������������������������������������������        ������������������������������������������������������������������


                 A type of relative
                  bioavailability




Bioequivalence


                              We compare an innovative product
                               (standard) with generic product


                        Anas Bahnassi PhD 2011                                                     10
Excipients

                                                                   Particle size
                     Formulation
                       Factors
                                                                   Crystalline or
                                                                    amorphous

                                                      Hydrous or
                                                      anhydrous
Factors affecting
 Bioavailability                                       Gastric
                                                      emptying

                                                                    Intestinal
                                                                     motility
                    Physiological
                      Factors
                                                                     GIT pH
                                                                    changes
                                                  Changes in
                       Anas Bahnassi PhD 2011
                                                intestinal wall            11
The First Pass Effect




   The fraction, f, of orally administered drug that
successfully passes through gut lumen and gut wall is
  then taken via the hepatic portal vein to the liver,
 where metabolism of the drug by enzymes may take
                          place.
This extraction by the liver of orally administered drug
             is called the first pass effect.

                    Anas Bahnassi PhD 2011                 12
Determination of the area under the
    plasma concentration–time curve from
       intravenous bolus administration
                                                                  ∞
           ������0 −������������
     ������������ = ������                                         ������������������ =       ������������ . ������������
            ������
                                                                  0
           ∞                       ∞
                             ������0              −������������
                                                                 ������0 −������������
������������������ =       ������������ . ������������ =             ������           . ������������ = −      ������ ∞ − ������ −������������0
                              ������                                 ������������
           0                       0
                                                                                     Extra-
                         ∞                                                          vascular
                                           ������0 ������������������������ ������������0
           ������������������ =          ������������ . ������������ =      =      =
                                           ������������   ������������   ������������
                        0
                                       Anas Bahnassi PhD 2011                            13
Determination of the area under the
    plasma concentration–time curve from
         extravascular administration
                                                                                          ∞
           ������������ ������������0
������������������ =               ������ −������������ − ������ −������������ ������                                  ������������������ =       ������������ . ������������
         ������(������������ − ������)                                                                    0
             ∞
                                   ������������ ������������0
  ������������������ =       ������������ . ������������ =                 ������ −������������ − ������ −������������ ������ . ������������
                                 ������(������������ − ������)
             0

            ������������ ������������0
 ������������������ =               ������ −������������ − ������ −������������������ ������∞
          ������(������������ − ������)

                        ������������ ������������0 ������������ − ������   ������������0 (������������ )0
             ������������������ =                        =       =
                      ������(������������ − ������) ������������������      ������������   ������������

                                            Anas Bahnassi PhD 2011                                   14
Cmax
Assessing Rate of
Absorption means
   comparing:
                                         tmax




                                                Peak
 Peak Time (tmax)                           Concentration
                                               (Cmax)
                Anas Bahnassi PhD 2011                  15
Bioavailability Testing
Administer Drug to                                  Minimum 12
                           For Relative
Healthy Individuals,                                 Subjects
                       Bioavailability Apply
Analyze Plasma and
                        Crossover Design           Normally 18-24
  Urine Samples



Informed Conscent
                         Fast Volunteers
 Medical Check up
                           Overnight
Laboratory Testing




                          Anas Bahnassi PhD 2011              16
Bioavailability Testing
1. Check the criteria for bioavailability testing.
2. Compare bioavailability parameters for products
3. being tested: AUC, peak plasma concentration, peak time
   and/or amount of drug excreted in urine (Xu).
4. Examine the information provided for statistical analysis.
5. Determine the percentage differences for each parameter
   between products being tested.
6. Apply the 20% rule as a rough indicator in the absence of
   statistical analysis.
7. Know the use of the drug being tested: is onset of action
   more important or duration? What is the therapeutic
   range? Is it narrow or broad?

                         Anas Bahnassi PhD 2011                 17
Example
     12 Subjects

                                         Randomly
                                        Assigned to 2
                                        groups (6/6)

 250mg of           250mg of Brand
Generic Drug            Drug
               Anas Bahnassi PhD 2011              18
������������������������������������������������������������ = ������������. ������������                            ������������������������������������������������ = ������������.79

������������������������������������������������������������                                                    Is it
                       = 0.9083
 ������������������������������������������������                       Anas Bahnassi PhD 2011
                                                                    acceptable?               19
Data Presentation




     Anas Bahnassi PhD 2011   20
Anas Bahnassi PhD 2011
                                             21
Data Presentation
How Equivalence Types are
                       No
   Same Drug
                                   Not
                                               Determined
  Yes                            Equivalent

                                                                              Therapeutic
 Same Amount of
                                                                               Equivalent
Active Ingredient in        No                     Pharmaceutical
 identical dosage                                    Alternative
        form                                                               Should
                                                                           Result in
  Yes

                        Yes          Significant              Yes
                                                                              Bioequivalent
  Pharmaceutical                    difference in
    Equivalent                     rate or extent
                                   of Absorption

                              Anas Bahnassi PhD 2011

                                                                Bioinequivalent

                                                                                        22
FDA Codes of
Bioequivalence




                      Anas Bahnassi PhD 2011
                 23
1
If a drug product passes official USP or                          Fallacies
    BNF standards then this assures
       bioavailability in humans.




                          2              Bioavailability must always be related
                                         to pharmacological effects or clinical
                                                        response.

   If drug products containing the
 same active ingredient(s) do have



                                                 3
  different bioavailabilities and/or
 different therapeutic differences,
    then this will be recognized in
      clinical use of the drug and
       reported in the scientific
                literature.
                                Anas Bahnassi PhD 2011                        24
In vitro rate of dissolution tests
                                                      Fallacies
                                     4
   can disclose differences in
      bioavailability and/or
       therapeutic effects
         without parallel
           data on the
            same drug
             products
            in human.

                         Differences in
                         bioavailability
                   From one manufacturer’s
             product to the next are less important



    5
                 than differences between the




                                                                 Anas Bahnassi PhD 2011
                   labeled dose and average
                    potency as determined
                       by chemical assay
                        in vitro or in vivo
                           in an animal
                              system.                       25
Pharmacokinetics

Anas Bahnassi PhD RPh

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Pharmacokinetics: Lecture Five

  • 1. Bioavailability and Bioequivalence Anas Bahnassi PhD RPh
  • 2. Lecture Objectives Upon the completion of this lecture the student should be able to: • Define terms bioavailability, absolute bioavailability, comparative bioavailability, bioequivalence, therapeutic equivalence, pharmaceutically equivalent products and pharmaceutical alternatives Anas Bahnassi PhD 2011 • Explain the difference between bioequivalence and therapeutic equivalence and describe whether bioequivalence will, in all cases, lead to therapeutic equivalence • Calculate absolute and relative bioavailability • Explain the manner in which parameters reflecting rate and extent of absorption are used to determine bioequivalence between two formulations; use equations to calculate these parameters • Explain the first-pass effect and its influence on bioavailability of a drug • Perform calculations to assess bioequivalency by the method employed by the US Food and Drug Administration (FDA) • Explain the FDA rating system for bioequivalency. 2
  • 3. Bioavailability Definitions The relative amount of an The rate and extent to which the active administered dose that reaches the ingredient or therapeutic moiety is general circulation and the rate at absorbed from a product and becomes which this occurs available at the site of drug action Anas Bahnassi PhD 2011 3
  • 4. Pharmaceutical Therapeutic or Chemical Equivalence Equivalence Means that two or more Two or drug products contain more chemically or equal amounts of the pharmaceutically same therapeutically equivalent active ingredients in identical dosage forms, products essentially and that these dosage produce the same efficacy forms meet the and/or toxicity in the same requirements such as individuals when purity, content uniformity administered in an and disintegration time as identical established by the United dosage States Pharmacopeia regimen. and/or National Formulary. Anas Bahnassi PhD 2011 4
  • 5. Bioequivalence Compare Bioequivalence and Two or more chemically or Therapeutic pharmaceutically equivalent products Equivalence produce comparable bioavailability characteristics in any individual when administered in equivalent dosage regimen (parameters compared include the area under the plasma concentration versus time curve (AUC) from time zero to infinity AUC , maximum plasma concentration and the time of peak concentration). Anas Bahnassi PhD 2011 5
  • 6. Bioavailability Absolute Relative Comparing bioavailability parameters derived from plasma or urine data between two different dosage forms or Comparing AUC or total Xu of two different extravascular routes of extravascular administration to administration intravascular administration Anas Bahnassi PhD 2011 6
  • 8. Absolute Bioavailability (������������������)������������������������������������������������������������������������������ (������������ )������������������������������������������������������������������������������ ������������������������������������������������������������������������������������������������������ ������������������������������������������������������������������������������������������������������ F= (������������������)������������ F= (������������ )������������ ������������������������������������ ������������������������������������ (������������������)������������������������ ������������������������������������ (������������ )������������������������ ������������������������������������ F= (������������������)������������ × ������������������������������������������������ F= × (������������ )������������ ������������������������������������������������ Anas Bahnassi PhD 2011 8
  • 9. Relative Bioavailability (������������������)������������������������ ������������������������������������ (������������ )������������������������������������ ������������������������������������������������������������������������ F= × F= × (������������������)������������ ������������������������������������������������ (������������ )������������������������������������������������ ������������������������������������������������������������ Anas Bahnassi PhD 2011 9
  • 10. (������������������)������������������������������������������ ������������������������������������������������������������������������ F= × (������������������)������������������������������������������������ ������������������������������������������������������������������ A type of relative bioavailability Bioequivalence We compare an innovative product (standard) with generic product Anas Bahnassi PhD 2011 10
  • 11. Excipients Particle size Formulation Factors Crystalline or amorphous Hydrous or anhydrous Factors affecting Bioavailability Gastric emptying Intestinal motility Physiological Factors GIT pH changes Changes in Anas Bahnassi PhD 2011 intestinal wall 11
  • 12. The First Pass Effect The fraction, f, of orally administered drug that successfully passes through gut lumen and gut wall is then taken via the hepatic portal vein to the liver, where metabolism of the drug by enzymes may take place. This extraction by the liver of orally administered drug is called the first pass effect. Anas Bahnassi PhD 2011 12
  • 13. Determination of the area under the plasma concentration–time curve from intravenous bolus administration ∞ ������0 −������������ ������������ = ������ ������������������ = ������������ . ������������ ������ 0 ∞ ∞ ������0 −������������ ������0 −������������ ������������������ = ������������ . ������������ = ������ . ������������ = − ������ ∞ − ������ −������������0 ������ ������������ 0 0 Extra- ∞ vascular ������0 ������������������������ ������������0 ������������������ = ������������ . ������������ = = = ������������ ������������ ������������ 0 Anas Bahnassi PhD 2011 13
  • 14. Determination of the area under the plasma concentration–time curve from extravascular administration ∞ ������������ ������������0 ������������������ = ������ −������������ − ������ −������������ ������ ������������������ = ������������ . ������������ ������(������������ − ������) 0 ∞ ������������ ������������0 ������������������ = ������������ . ������������ = ������ −������������ − ������ −������������ ������ . ������������ ������(������������ − ������) 0 ������������ ������������0 ������������������ = ������ −������������ − ������ −������������������ ������∞ ������(������������ − ������) ������������ ������������0 ������������ − ������ ������������0 (������������ )0 ������������������ = = = ������(������������ − ������) ������������������ ������������ ������������ Anas Bahnassi PhD 2011 14
  • 15. Cmax Assessing Rate of Absorption means comparing: tmax Peak Peak Time (tmax) Concentration (Cmax) Anas Bahnassi PhD 2011 15
  • 16. Bioavailability Testing Administer Drug to Minimum 12 For Relative Healthy Individuals, Subjects Bioavailability Apply Analyze Plasma and Crossover Design Normally 18-24 Urine Samples Informed Conscent Fast Volunteers Medical Check up Overnight Laboratory Testing Anas Bahnassi PhD 2011 16
  • 17. Bioavailability Testing 1. Check the criteria for bioavailability testing. 2. Compare bioavailability parameters for products 3. being tested: AUC, peak plasma concentration, peak time and/or amount of drug excreted in urine (Xu). 4. Examine the information provided for statistical analysis. 5. Determine the percentage differences for each parameter between products being tested. 6. Apply the 20% rule as a rough indicator in the absence of statistical analysis. 7. Know the use of the drug being tested: is onset of action more important or duration? What is the therapeutic range? Is it narrow or broad? Anas Bahnassi PhD 2011 17
  • 18. Example 12 Subjects Randomly Assigned to 2 groups (6/6) 250mg of 250mg of Brand Generic Drug Drug Anas Bahnassi PhD 2011 18
  • 19. ������������������������������������������������������������ = ������������. ������������ ������������������������������������������������ = ������������.79 ������������������������������������������������������������ Is it = 0.9083 ������������������������������������������������ Anas Bahnassi PhD 2011 acceptable? 19
  • 20. Data Presentation Anas Bahnassi PhD 2011 20
  • 21. Anas Bahnassi PhD 2011 21 Data Presentation
  • 22. How Equivalence Types are No Same Drug Not Determined Yes Equivalent Therapeutic Same Amount of Equivalent Active Ingredient in No Pharmaceutical identical dosage Alternative form Should Result in Yes Yes Significant Yes Bioequivalent Pharmaceutical difference in Equivalent rate or extent of Absorption Anas Bahnassi PhD 2011 Bioinequivalent 22
  • 23. FDA Codes of Bioequivalence Anas Bahnassi PhD 2011 23
  • 24. 1 If a drug product passes official USP or Fallacies BNF standards then this assures bioavailability in humans. 2 Bioavailability must always be related to pharmacological effects or clinical response. If drug products containing the same active ingredient(s) do have 3 different bioavailabilities and/or different therapeutic differences, then this will be recognized in clinical use of the drug and reported in the scientific literature. Anas Bahnassi PhD 2011 24
  • 25. In vitro rate of dissolution tests Fallacies 4 can disclose differences in bioavailability and/or therapeutic effects without parallel data on the same drug products in human. Differences in bioavailability From one manufacturer’s product to the next are less important 5 than differences between the Anas Bahnassi PhD 2011 labeled dose and average potency as determined by chemical assay in vitro or in vivo in an animal system. 25
  • 26. Pharmacokinetics Anas Bahnassi PhD RPh abahnassi@gmail.com http://twitter.com/abahnassi http://www.linkedin.com/in/abahnassi http://www.udemy.com/pharmacokinetics http://www.slideshare.net/abahnassi attribution – non-commercial – share alike