Drug Prodact performance in vivo

1. Prepared by,
Dnyaneshwar Bharat Ningule
( First Year M.pharm Roll no.10 )
Department of Pharmaceutics
Vasantidevi Patil Institute of Pharmacy , Kodoli

2. SR. INDEX
1 Introduction
2 Flow of presentation
3 Drug product performance (in vivo)
4 Bioeqivalant studies in new drug devlopment in (nda)
5 Bioeqivalant studies in genric drug devlopment in (anda)
6 Purpose of bioavailability studies
7 Absolute availability
8 Relative availability
9 Methods for assessing bioavailability
10 Bioequivalence studies
11 Design an evaluation of bioequivalence studies
12 Study design
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3. Drug product performance,1 in vivo, may be defined as the release
of the drug substance from the drug product leading to
bioavailability of the drug substance. The assessment of drug
product performance is important since bioavailability is related
both to the pharmacodynamic response and to adverse events.
INTRODUCTION
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4. FLOW OF PRESENTATION
oDrug Productl'erformance (In vivo)
oBioavailability and Bioequivalence
oMethods for assessing bioavailability
oBiocquivalence studies
oDesign and evaluation of bioequivalence studies
oStudy designs
oCrossover study designs
oStudy submission and Drug review process
oReferences
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5. DRUG PRODUCT PERFORMANCE (IN VIVO)
o The release of the drug substance from the drug product leading to
bioavailability of the drug substance. The assessment of drug product
performance is imp. Since bioavailability is related both to the
pharmacodynamic responses and the adverse events. The performance
tests relate the quality of a drug product to clinical safety and efflcacy.
o Bioavailabilty studies are drug product performance studies used to
define
the effect of changes in the physicochemical properties of the drug
substance, the formulation of the drug, and the manufacture process
of the drug product.
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6. BIOEQIVALANT STUDIES IN NEW DRUG
DEVLOPMENT IN (NDA)
Used to compare :-
Early and late clinical trial nformulation
Formulation used in clinical trials and stability studies,if different
Clinical trial formulation and to be marketed drug product,if different
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7. BIOEQIVALANT STUDIES IN
GENRIC DRUG DEVLOPMENT IN
(ANDA)
Geric drug product is a multisource drug product that has
been approved by the FDA has theraputic eqivalance to the
refrence listed drug product and has proven eqvivalant drug
product performance
The genric drug manufacturer must demonstrate the genric
drug produt is pharmaceutical equivalent,bioeuivalant,and
theraputically equivalent to the comprator brand name drug
product
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8. PURPOSE OF BIOAVAILABILITY STUDIES
o Bioavailability studies are performed for both approved
active drug ingredients and therapeutic moieties not yet
approved for marketing by the FDA.
o New formulations of active drug ingredients must be
approved by the FDA before marketing.
o FDA ensures that the drug product is safe and effective for
its labeled ind ications a re use.
o The drug product must meet all applicable standards of
identity, strength,quality, and purity.
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9. ABSOLUTE AVAILABILITY
o When the systemic availability of a
drug administered orally is determined
in comparison to its intravenous
administration , it is called as absolute
bioavailability.
o It is denoted by symbol F. Its
determination is used to characterize a
drugs absorption properties from the
e.v. site.
Absolute availability(Fabs) = (1UC] po/ dose po
( AUC) IV / d= IV
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10. RELATIVE AVAILABILITY
o When the systemic availability of a drug
after oral administration is compared with
that of an oral standard of the same drug. It
is referred to as relative or comparative
bioavailability.
o It is denoted by symbol Fr . It is used to
characterize absorption of a drug from its
formula! ion.
Relative avallahllily = (AUC)a Db •too
(Frcl) (AUC)b D a
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11. METHODS FOR ASSESSING
BIOAVAILABILITY
o In vivo measurement of active moiety or moieties in biological fluids
• Plasma drug concentration
• tmax
• Cmax
• AUC
o Urinary Drug excretion
o In vivo pharmacodynamic comparison
o Clinical endpoint study
o In vitro studies
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12. BIOEQUIVALENCE STUDIES
o Differences in the predicted clinical response or an adverse
event may be due to differences in the pharmacokinetic or
pharmacodynamic behaviour of the drug.
o Bioequivalent drug products that have the same systemic drug
bioavailability will have the same predictable drug response.
Howevc1; variable clinical responses among individuals that are
unrelated to
bioavailability may be due to differences in the phannacodynamics
of the drug.
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13. DESIGN AN EVALUATION OF BIOEQUIVALENCE
STUDIES
o Bioequivalence stt1dies are performed to compare the
Bioavailability of the generic drug prodl1ct to the brand
name product.
o Statistical techniques should be of sufficient sensitivity to
detect differences in rate and extent of absorption that
are not attributable to subject variability.
o Once bioequivalence is established, it is likely that both
the generic and brand name dosage forms will produce
the same therape11tic effect.
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14. STUDY DESIGN
o For many drug products, the FDA. Division of
Bioeq11ivalence, Office of Generic Drugs, provides
guidance for the performance of in-vitro dissolution
and in-vivo bioequivalence studies. Similar guidelines
appear in the United States Ph<mnacopoeia NF.
o Currently, three different studies may be required for
solid oral dosage forms. Including
1. Fasting study
2. Food intervention study
3. Multiple-dose study
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15. VPIP,KODOLI DEPARTMEN T
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REFERENCE
https://www.google.com/search?q=drug+performance+in+vivo
https://www.slideshare.net/SayaliDarekar/assignment-drug-
product-performance-invivo
Regulatoryu affairs Pv publication text book

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