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Presented By: Rajashree Ghogare
M Pharm Pharmacology
Assistant Professor at PRCOP, Loni
Bioavailability and Bioequivalence
List of content
Definitions
• BA
• BE
Objectives
• Objectives BA
• Objectives of BE
• Methods of
measurements
of BA,BE
• Study Design
Requirement for
conducting BA-Be
study
Biowaiver,
Biosimilar
Scope for Students
Definition
• Bioavailability (BA) : Bioavailability refers to the
relative amount of drug from an administered dosage
from which enters the systemic circulation and the rate
at which the drug appears in the systemic circulation.
• Bioequivalence (BE): Bioequivalence of a drug product
is achieved if its extent and rate of absorption are not
statistically significantly different from those of the
reference product when administered at the same
molar dose.
• Innovator Drug/Product-Approved as a new
drug
• Generic Drug/Product-Product which have
same API, strength, dosage form, dosage
regimen(Administered by same route),
Volunteers/Subjects:
Period
Sequence Washout Period
Bioavailability Study
Bioavailability (BA)
Types- Absolute / Relative(Comparative)
• ‘’Absolute-’’bioavailability compares one non-
IV route with IV administration.
• "Relative" bioavailability compares one non-
IV route or formulation with another (instead
of using IV route as a reference).
Factor affecting on Bioavailability
Pharmaceutical Factor related to
physicochemical
Solubility of Drug,Permeability,particle size…etc
Patient related Factor
Age, Gender, Obesity, Disease condition
Route of administration
Parenteral >Oral>Rectal>Topical
Bioavailability Fraction
Methods of Bioavailability
Measurement
• Plasma Level-Time
Studies
• Urinary Excretion Studies
PK
(Indirect)
• Acute Pharmacological
response
• Therapeutics Response
PD
(Direct)
PK Studies(Indirect method)
1.plasma drug conc profile determination by
using series of sample blood.
2.Urine analysis
PD Methods
1.Acute Pharmacological response Methods
2. Therapeutic Response Methods-
• ECG,
• EEG,
• Pupil Diameter
• DRC Graph
Bioequivalence Study
IN VIVO
IN VITRO
Study Design
• 1.Parallel Design-Each subject will received
one type of formulation.
• Disadvantage-Inter subject variation will be
there.
Group Formulations
Period I Period II
1
A(Test)
A(Test)
2 B (STD) B (STD)
2.Cross Over Design-
Latin Square cross over design
Each subject is administered The Test and STD
formulation.
Group Sequence Formulations
Period I
Washout
Period/Time
Period II
1
AB A(Test)
B (STD)
2 BA B (STD) A(Test)
3.3Period 3Sequence cross over design
Grou
p
Sequence Formulations
Period I
Washout
Period/Time
Period II
Washout
Period/Tim
e
Period III
1 ABC A
B
C
2 BCA B C A
3 CAB C A B
4.4Period 4 sequence cross over design
Gr
ou
p
Sequ
ence Formulations
Period I
Washou
t
Period/T
ime
Perio
d II
Washou
t
Period/
Time
Period III
Washout
Period/Ti
me
Period IV
1 ABCD A
B
C D
2 BCDA B C D A
3 CDAB C D A B
4 DABC D A B C
Balanced incomplete block design
Subjects
are
randomly
asigned
Subjects Formulations
Period I Period II
1 A B
2 B A
3 A C
4 C A
5 A D
6 D A
7 B C
8 C B
9 B D
10 D B
11 C D
12 D C
Requirement for conducting BA-BE study
• Guideline For BA-Be Study-
guidance_doc_BABE_NOC1_1Jan2018.pdf
• Updated list BA-BE dt. 10.06.21.pdf
• CT Rule 2019 23NEW DRUGS AND
CLINICAL TRIALS RULES, 2019.pdf
• GCP inspection Checklist-
GCPInspChecklist16.pdf
• Sugam portal
• AE reporting on time
Biowaiver
• A biowaiver is applicable when the drug substance(s) in test
and reference products are identical. A biowaiver may also be
applicable if test and reference products contain different
salts provided that both belong to BCS Class I
• must contain the same active and inactive ingredients (Q1) in
the same dosage form and concentration (Q2) and have the
same pH and physico-chemical characteristics (Q3) as an
approved
• In vitro preferred than In vivo
• Amlodipine is classified according to BCS as a Class I drug
therefore qualifies for biowaiver.
Biosimilar
• A biosimilar is a biological medicine highly
similar to another already approved biological
medicine (the 'reference medicine').
Biosimilars are approved according to the
same standards of pharmaceutical quality,
safety and efficacy that apply to all biological
medicines.
SCOPE FOR BA-BE
Clinical research-CRO centre
CDSCO vacancies
sugam portal
Clinical trials,BA-Be trails- co-ordinator
Medical Writer- Protocol, EC ,Informed consent
writing,Clinical study report..etc.
Ethical committee member
Bioavailability & Bioequivalence  Studies- Definitions, Methods  of Measurement of BA-BE ,Study Design, Requirement for conducting BA-BE study, Biowaiver, Biosimilar

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Bioavailability & Bioequivalence Studies- Definitions, Methods of Measurement of BA-BE ,Study Design, Requirement for conducting BA-BE study, Biowaiver, Biosimilar

  • 1. Presented By: Rajashree Ghogare M Pharm Pharmacology Assistant Professor at PRCOP, Loni Bioavailability and Bioequivalence
  • 2. List of content Definitions • BA • BE Objectives • Objectives BA • Objectives of BE • Methods of measurements of BA,BE • Study Design Requirement for conducting BA-Be study Biowaiver, Biosimilar Scope for Students
  • 3. Definition • Bioavailability (BA) : Bioavailability refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation. • Bioequivalence (BE): Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.
  • 4. • Innovator Drug/Product-Approved as a new drug • Generic Drug/Product-Product which have same API, strength, dosage form, dosage regimen(Administered by same route),
  • 7. Bioavailability (BA) Types- Absolute / Relative(Comparative) • ‘’Absolute-’’bioavailability compares one non- IV route with IV administration. • "Relative" bioavailability compares one non- IV route or formulation with another (instead of using IV route as a reference).
  • 8. Factor affecting on Bioavailability Pharmaceutical Factor related to physicochemical Solubility of Drug,Permeability,particle size…etc Patient related Factor Age, Gender, Obesity, Disease condition Route of administration Parenteral >Oral>Rectal>Topical
  • 10. Methods of Bioavailability Measurement • Plasma Level-Time Studies • Urinary Excretion Studies PK (Indirect) • Acute Pharmacological response • Therapeutics Response PD (Direct)
  • 11. PK Studies(Indirect method) 1.plasma drug conc profile determination by using series of sample blood. 2.Urine analysis
  • 12. PD Methods 1.Acute Pharmacological response Methods 2. Therapeutic Response Methods- • ECG, • EEG, • Pupil Diameter • DRC Graph
  • 14. Study Design • 1.Parallel Design-Each subject will received one type of formulation. • Disadvantage-Inter subject variation will be there. Group Formulations Period I Period II 1 A(Test) A(Test) 2 B (STD) B (STD)
  • 15. 2.Cross Over Design- Latin Square cross over design Each subject is administered The Test and STD formulation. Group Sequence Formulations Period I Washout Period/Time Period II 1 AB A(Test) B (STD) 2 BA B (STD) A(Test)
  • 16. 3.3Period 3Sequence cross over design Grou p Sequence Formulations Period I Washout Period/Time Period II Washout Period/Tim e Period III 1 ABC A B C 2 BCA B C A 3 CAB C A B
  • 17. 4.4Period 4 sequence cross over design Gr ou p Sequ ence Formulations Period I Washou t Period/T ime Perio d II Washou t Period/ Time Period III Washout Period/Ti me Period IV 1 ABCD A B C D 2 BCDA B C D A 3 CDAB C D A B 4 DABC D A B C
  • 18. Balanced incomplete block design Subjects are randomly asigned Subjects Formulations Period I Period II 1 A B 2 B A 3 A C 4 C A 5 A D 6 D A 7 B C 8 C B 9 B D 10 D B 11 C D 12 D C
  • 20. • Guideline For BA-Be Study- guidance_doc_BABE_NOC1_1Jan2018.pdf • Updated list BA-BE dt. 10.06.21.pdf • CT Rule 2019 23NEW DRUGS AND CLINICAL TRIALS RULES, 2019.pdf • GCP inspection Checklist- GCPInspChecklist16.pdf • Sugam portal • AE reporting on time
  • 21.
  • 22. Biowaiver • A biowaiver is applicable when the drug substance(s) in test and reference products are identical. A biowaiver may also be applicable if test and reference products contain different salts provided that both belong to BCS Class I • must contain the same active and inactive ingredients (Q1) in the same dosage form and concentration (Q2) and have the same pH and physico-chemical characteristics (Q3) as an approved • In vitro preferred than In vivo • Amlodipine is classified according to BCS as a Class I drug therefore qualifies for biowaiver.
  • 23. Biosimilar • A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.
  • 24. SCOPE FOR BA-BE Clinical research-CRO centre CDSCO vacancies sugam portal Clinical trials,BA-Be trails- co-ordinator Medical Writer- Protocol, EC ,Informed consent writing,Clinical study report..etc. Ethical committee member