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1
Ethical
Considerations In
Bioequivalence
Studies
Usama Jamshaid
2
Ethics
Ethics means: Moral principles that govern
a person's behavior or the conducting of an
activity.
3
Bioavailability
 Bioavailability means the rate and extent to which
the active ingredient or active moiety is absorbed
fr...
Bioequivalence
Two products are bioequivalent if
 they are pharmaceutically equivalent
 the bioavailable concentrations ...
Ethical Guidelines for Research with Humans
One set of guidelines specifically developed to
guide research conducted by e...
Basic Ethical Principles
 1. Respect for Persons
 2. Beneficence
 3. Justice
7
Essential Parameters
 1. Informed Consent
 2. Assessment of Risks and Benefits
 3. Selection of Subjects
8
Study Design
In order to reduce variability a cross over
design usually is the first choice.
Other designs or methods ma...
Selection of subjects
 Subjects could belong to both sexes; however, the risk to women of
childbearing potential should b...
 If the purpose of the bioequivalence
study is to address specific questions such
as investigation of differences in
bioa...
Inclusion of Volunteers
 If the investigated active substance is known to
have adverse effects or risks then it is consid...
Informed Consent
 This is the process of providing the research participants
with information enables them to make an inf...
Informed Consent with Minors as
Research Participants
Consent must be obtained from parents or
guardians.
Assent must al...
Deception
Providing false information to the participant
about the nature and/or purpose of the study
 It is discouraged...
Freedom to Withdraw
 Participants must be informed that they
are free to withdraw from the study at any
time without pena...
Protection from Mental and Physical Harm
This is the most fundamental ethical issue
confronting the researcher.
Educatio...
Elements of a Bioavailability/Bioequivalence Study
Protocol
I. Title
  A. Principal investigator (study director)
  B. Pro...
Elements of a Bioavailability Study Protocol
IV. Study population
  A. Subjects
  B. Subject selection
    1. Medical hist...
Elements of a Bioavailability Study Protocol
V. Clinical procedures
A. Dosage and drug administration
B. Biological sampli...
Institutional Review Board
 This is a board consisting of professionals and lay people who review
research proposals to i...
There are three ways, and three ways only, to
encourage participation ethically (Senese
1997):
 Anonymity:
 Keep promise...
o Informed Consent:
 Be honest and fair with your subjects.
 Tell them every thing about your research.
 Subjects shoul...
Ethical Principles
 1. It is the duty of the health care professionals to promote and
safeguard the health of the people....
 5. The primary purpose of medical research involving human subjects is to
improve prophylactic, diagnostic and therapeut...
 8. Medical research is only justified if there is a reasonable
likelihood that the populations in which the research is
...
 11. For a research subject who is legally incompetent, physically or
mentally incapable of giving consent or is a legall...
References
 Applied Biopharmaceutics & Pharmacokinetics, 5th Edition, Leon
Shargel, Susanna Wu-Pong, Andrew B.C. Yu
 Con...
THANK YOU
THANK YOU
29
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Ethical considerations

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Ethical considerations

  1. 1. 1
  2. 2. Ethical Considerations In Bioequivalence Studies Usama Jamshaid 2
  3. 3. Ethics Ethics means: Moral principles that govern a person's behavior or the conducting of an activity. 3
  4. 4. Bioavailability  Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action.  In case of IV administration, bioavailability is almost 100% but when a drug is administered orally, bioavailability is decreased. 4
  5. 5. Bioequivalence Two products are bioequivalent if  they are pharmaceutically equivalent  the bioavailable concentrations following administration are same and giving the same effect 5
  6. 6. Ethical Guidelines for Research with Humans One set of guidelines specifically developed to guide research conducted by educational researchers is the AERA Guidelines. The AERA is the largest professional association in the field of education, and is also known as the American Educational Research Association. 6
  7. 7. Basic Ethical Principles  1. Respect for Persons  2. Beneficence  3. Justice 7
  8. 8. Essential Parameters  1. Informed Consent  2. Assessment of Risks and Benefits  3. Selection of Subjects 8
  9. 9. Study Design In order to reduce variability a cross over design usually is the first choice. Other designs or methods may be chosen in specific situations, but should be fully justified in the protocol and final study report. The subjects should be allocated to treatment sequences in a randomized order. 9
  10. 10. Selection of subjects  Subjects could belong to both sexes; however, the risk to women of childbearing potential should be considered on an individual basis.  In general, subjects should be between 18 – 55 years old, capable of giving informed consent and of weight within the normal range or Body Mass Index (BMI) of 18 - 30.  They should be screened for suitability by means of clinical laboratory tests, an extensive review of medical history, and a comprehensive medical examination.  Subjects should preferably be nonsmokers and without a history of alcohol or drug abuse. If moderate smokers are included (less than 10 cigarettes per day) they should be identified as such and the consequences for the study results should be discussed. 10
  11. 11.  If the purpose of the bioequivalence study is to address specific questions such as investigation of differences in bioavailability in different subsets of the population or drug/drug interactions the selection criteria and the statistical analysis should be adjusted accordingly. 11
  12. 12. Inclusion of Volunteers  If the investigated active substance is known to have adverse effects or risks then it is considered unacceptable for healthy volunteers, it may be necessary to use patients instead under suitable precautions and supervision.  In this case the applicant should justify the alternative. 12
  13. 13. Informed Consent  This is the process of providing the research participants with information enables them to make an informed decision as to whether they want to participate in the research study.  State the purpose of the research and describe the procedures to be followed.  Describe any potential risks or discomforts the participant may encounter.  Describe any potential benefits from participation.  Describe extent to which results will be kept confidential.  Give a list of names the participants may contact with any questions they have.  State that participant is voluntary and that they are free to withdraw from the study at any time. 13
  14. 14. Informed Consent with Minors as Research Participants Consent must be obtained from parents or guardians. Assent must also be obtained from minors who are old enough or have enough intellectual capacity to say they are willing to participate. 14
  15. 15. Deception Providing false information to the participant about the nature and/or purpose of the study  It is discouraged by the AERA, but not disallowed in allIt is discouraged by the AERA, but not disallowed in all cases.cases.  Sometimes deception is required in order to conduct a validSometimes deception is required in order to conduct a valid research study. The researcher must justify the use ofresearch study. The researcher must justify the use of deceptiondeception.. 15
  16. 16. Freedom to Withdraw  Participants must be informed that they are free to withdraw from the study at any time without penalty.  If you have a power relationship with the participants you must be extra careful to make sure that they really do feel free to withdraw. 16
  17. 17. Protection from Mental and Physical Harm This is the most fundamental ethical issue confronting the researcher. Educational research generally poses minimal risk to participants. 17
  18. 18. Elements of a Bioavailability/Bioequivalence Study Protocol I. Title   A. Principal investigator (study director)   B. Project/protocol number and date II. Study objective III. Study design   A. Design   B. Drug products     1. Test product(s)     2. Reference product   C. Dosage regimen   D. Sample collection schedule   E. Housing/confinement   F. Fasting/meals schedule   G. Analytical methods 18
  19. 19. Elements of a Bioavailability Study Protocol IV. Study population   A. Subjects   B. Subject selection     1. Medical history     2. Physical examination     3. Laboratory tests   C. Inclusion/exclusion criteria     1. Inclusion criteria     2. Exclusion criteria   D. Restrictions/prohibitions 19
  20. 20. Elements of a Bioavailability Study Protocol V. Clinical procedures A. Dosage and drug administration B. Biological sampling schedule and handling procedures C. Activity of subjects VI. Ethical considerations A. Basic principles B. Institutional review board C. Informed consent D. Indications for subject withdrawal E. Adverse reactions and emergency procedures VII. Facilities VIII. Data analysis A. Analytical validation procedure B. Statistical treatment of data IX. Drug accountability 20
  21. 21. Institutional Review Board  This is a board consisting of professionals and lay people who review research proposals to insure that the researcher will adhere to ethical standards in the conduct of the research.  Researchers must submit a Research Protocol to the IRB for review  Three of the most important categories of review are exempt studies, expedited review, and full board review  Much educational research falls in the exempt category because the study involves no or minimal risk  Studies with children, prisoners, and fetal participants are never exempt  Even if your study ultimately falls in the exempt category, it is still essential that you follow the ethical guidelines 21
  22. 22. There are three ways, and three ways only, to encourage participation ethically (Senese 1997):  Anonymity:  Keep promises anonymous.  After identifying your sample try to forget taking names or other identification.  Reassure people not to go to media.  Confidentiality:  Use confidentiality if you cannot guarantee anonymity.  It requires that you guarantee that no one will be individually identified in any way by you. 22
  23. 23. o Informed Consent:  Be honest and fair with your subjects.  Tell them every thing about your research.  Subjects should not have any pressure to participate in your research. 23
  24. 24. Ethical Principles  1. It is the duty of the health care professionals to promote and safeguard the health of the people.  2. The Declaration of Geneva of the World Medical Association binds the health care professionals with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A health care professional shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."  3. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.  4. In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society. 24
  25. 25.  5. The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the etiology and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality.  6. In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks and burdens.  7. Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress. 25
  26. 26.  8. Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.  9. The subjects must be volunteers and informed participants in the research project.  10. When obtaining informed consent for the research project the health care professional should be particularly cautious if the subject is in a dependent relationship with the investigator or may consent under duress. 26
  27. 27.  11. For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law.  12. When a subject is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. 27
  28. 28. References  Applied Biopharmaceutics & Pharmacokinetics, 5th Edition, Leon Shargel, Susanna Wu-Pong, Andrew B.C. Yu  Concepts In Clinical Pharmacokinetics - 4th Ed. (2005) ,Joseph T. DiPiro Pharm.D., William J. Spruill Pharm.D., FASHP, William E. Wade Pharm.D., FASHP, Robert A. Blouin Pharm.D.  Abernethy DR, Azarnoff DL: Pharmacokinetic investigations in elderly patients. Clinical and ethical considerations. Clin Pharmacokinet 19:89– 93, 1990 [PMID: 2379383] .  Malaysian guidelines for the conduct of bioavailability and bioequivalence studies, September 2000, Ministry of Health, Malaysia.  The Code of Ethics of the American Educational Research Association (AERA) , February 2011. 28
  29. 29. THANK YOU THANK YOU 29

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