This document discusses post-marketing surveillance, outsourcing bioavailability and bioequivalence studies to contract research organizations. It provides an introduction to post-marketing surveillance, describing its role in monitoring drug safety after market approval. A brief history is given of pivotal drug safety issues that led to the establishment of formal post-marketing surveillance systems. Common sources of post-marketing information are also outlined. The document defines outsourcing, bioavailability, bioequivalence, and contract research organizations. It explains how outsourcing is used to reduce costs and improve efficiency through utilizing external partners for certain studies and services.

1. Post Marketing
Surveilance,Outsourcing BA and BE to
CRO
Presented by,
Jahnabi Sarmah
Dept. of pharmacy
M.Pharm 1st sem
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Guided by,
Dr. Satyendra Deka
Associate professor
Dept. of pharmacy

2. Content:
• Introduction of post marketing surveilance.
• History of PMS.
• Need of post marketing surveilance.
• Sources of post marketing surveilance.
• Introduction, definition and examples of
outsourcing-
-Bioavailability,
-Bioequivalence,
-CRO (Contract Research Organisation).
• Reference.
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3. Post marketing
surveilance(PMS):
Post marketing surveilance is the practice of
monitoring the safety of a pharmaceutical drug or
medical device after it has been released on the
market and is an important part of the science.
To market a drug, the manufacturer must provide
evidence of its efficacy and safety to the US
FOOD AND Drug Administration(FDA).
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4.  It play an important role to discover an undesirable
effect that might present at risk.
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5. History of PMS:
 In 1960, two serious drugs reaction were observed in
many patient. Eg The drug thalidomide, taken
worldwide and causes limb deformities(phocomelia).
 In Japan, optic nerve damage was observed due to
the adverse effect of drug clioquinol.
 The senator Edward Kennedy suggested that a better
system was need for monitoring the use and effects
of prescribed drug after they are marketed.
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6.  As a results, the joint commissionon Prescription
Drugs Use was established in 1976, funded largely by
the drug industry, with the mandate to design a post
marketing surveilance system to detect, quantify and
describe the anticipated and unanticipated effects of
marketed drugs.
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7. Need of PMS SYSTEM:
 The primary objective of PMS is to develop
information about the drug effects under customary
condition of drug use.
 Rare adverse events may not be detected in pre
licensure studies because in very large clinical trials
have limitation.
 Access to more patient and given data.
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8. Sources of PMS information:
 Customer surveys.
 Literature reveiws.
 Expert user groups.
 Customer complaints.
 The media etc.
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9. What is outsourcing?
• Outsourcing is the business
practice of hiring a party
outside a company to perform
services and create goods that
traditionally were
performed in-house by the
company's own employees and
staff.
▫
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10.  Outsourcing was first recognized as a business
strategy in 1989 and became an integral part of
international business economics.
 Outsourcing is generally done to reduce the costs and
improving the efficient resources within a company.
Ex of outsourcing is bioavailability, bioequivalence,
R & D department etc.
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11. Bioavailability:
• Measurement of the amount and rate at which the
drug from administered dosage form, reaches the
systemic circulation and becomes available at the site
of action.
• Bioavailability describes the concentration of drug in
systemic blood in relation to the amount of drug
given.
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12. Therapeutic relevance:
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13. Objective:
• In R & D of suitable dosage form.
• Determination of influence of excipient, patient
related factors and drug interaction on the efficiency
of absorption.
• QC of dosage form etc.
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14. Bioequivalence:
It is a relative term which denotes that the
drug substance in two or more identical dosage form,
reaches the systemic circulation at the same relative
rate and to the same relative extent i.e; their plasma
concentration-time profiles will be identical without
significant statistical differences.
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15. Types of equivalence:
 Chemical Equivalence:
It indicates that two or more drug product contain
the same labelled chemical substances as an active
ingredient in the same amount.
 Pharmaceutical Equivalence:
This term implies that two or more drug products
are identical in strenght, quality, purity, content uniformity
and disinegration and dissolution characteristics. They may
however, differ in containing different excipients.
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16. Therapeutic equivalence:
This term indicates that two or more drug
products that contain the same therapeutically active
ingredients elicit identical pharmacological effects and
can control the disease to the same extent.
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17. CRO (Contract Research
Organisation):
 A contract research organisation(CRO) is an
organisation that provide support to the
pharmaceutical, biotechnology and medical device
industries in the form of research services outsourced
 It offers various pharmaceutical research that is
essential for conducting clinical trials, the ICH
technical requirements for registration of
pharmaceuticals for human use.
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18. REFERENCE:
• FOOD AND DRUG ADMINISTRATION “
Supplementary reports to contracts and grants
committee on Medicaid”, from the division of Drugs
experience, BUREAU OF DRUGS, 1982, 10-32.
• Introduction to Postmarketing Drug Safety Surveilance: LT
Andrew Fine, Pharm.D, BCPS.
• Pharmaceutical Regulations in Japan: Chapter-4.
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