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Gcp final

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Gcp final Gcp final Presentation Transcript

  • PREPARED BY:SOMNATH NAVGIRE M. PHARM II: (PHARMACEUTICS) DEPARTMENT OF PHARMACEUTICAL SCIENCES, RASHATRASANT TUKDOJI MAHARAJ NAGPUR UNIVERSITY, NAGPUR.
  • Good Clinical Practice Refers to Good Clinical (Research) Practice
  • •These guidelines have been evolved with consideration of WHO, ICH, USFDA and European GCP guidelines as well as the Ethical Guidelines for Biomedical research on Human Subjects issued by the Indian Council of Medical Research •The objective of this ICH GCP Guideline is to provide a unified standard for European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
  • International Scientific & Ethical quality Standard DESIGN COLLECT Patient Safety Credibility of Data The Concept of Good Clinical Practice
  •  Tuskegee trials - 1930s  German prisoners trials - 1940s  Thalidomide Disaster – 1960s  Sulfanilamide disaster of 1937
  •  Tuskeegee Trial (Alabama, U.S.A., 1932-1972)  > 600 men with syphilis  50% randomized to treatment  50% randomized to NO TREATMENT ◦ Result: Untreated patients fared poorly A significant number of patients died  No information given to patients; no permission was sought to withhold treatment; no clear endpoints.  Outcome: Litigation, financial settlements
  •  German prisoner research trials (1940’s)  Objectives of various trials: ◦ Effect of cold, heat, chemicals on men, women and children ◦ “Time to death” testing in response to stressors in healthy “volunteers” ◦ Organ transplant experiments on healthy “volunteers”  Any information given (some?) is irrelevant because prisoners were forced to participate  Outcome: ◦ 25 German scientists taken to court, 7 acquitted, 9 imprisoned, 9 given death sentence ◦ Nuremberg Code of 1947
  •  In 1962 , thalidomide, a sleeping pill developed & widely used abroad, was being studied for used in U.S.  William S.Merrell company of Cincinnati was using drug investigationally  Dr. Frances Kelsey at the FDA delayed approval of the NDA by asking the sponsor for more information about neuritis as a possible side effect
  •  However, even though the NDA was withdrawn, the FDA discovered that 2.5 million tablets of thalidomide were distributed to 1,270 U.S. physicians as samples  200,000 American patients received thalidomide  By the mid-1960s, 10,000 birth defects occurred worldwide  approximately 10,000 children were born with severe malformities, including phocomelia, because their mothers had taken thalidomide during pregnancy
  •  This resulted in Kefauver-Harris Amendment of 1962,which address the issue of effectiveness and safety
  •  Sulfanilamide drug used to treat a staphylococcal infection. drug shown dramatic curative effect & have been used for sometime in tablet & powdered form, but in southern estate it demand as liquid form  Watkins experimented & found that Sulfanilamide dissolve in diethylene glycol  New formulation had not been tested for toxicity
  • Catalyst Event  Sulfanilamide Tragedy  Nazi Physicians Trial  Thalidomide Tragedy  Syphilis Study Regulatory Milestone Food, Drug, and Cosmetic Act Nuremberg Code Kefauver-Harris Amendments National Research Act
  •  Untested AIDS Vaccine in Human Trials. ◦ Good Clinical Practice Journal 6(3):5-6, 1999  Case background: ◦ Dr. Ishwar Gilada, Indian Health Organization ◦ Administered untested vaccine to 10 HIV- positive patients (Manisyl, a bovine immunodeficiency virus vaccine) ◦ No permission sought from DCGI ◦ Patient took case to court
  •  History – the regulation were originally concerned with “ Quality, Identity & purity” of product not with efficacy & safety of drug substance /product  The regulation of GCP start after some dangerous event occur
  • 1. Event occur-when more than 100 children die after taking strep-elixir (sulfanilamide & diethylene glycol) Reaction of event -1938 Federal Food Drug & cosmetic Act required that drug to be tested for safety 2. Event –between 1950-1960 thousand of children born with Phocomelia (seal limbs) when taken by a pregnant women during pregnancy Reaction of event- the kefauver Harris amendment of 1962 passed by U.S. congress. It include  Evidence of efficacy of drug before approval  Evidence of safety before testing in human  Give protection to human in research
  •  The rights, safety,& wellbeing of trial patient are most important  The trial should be conducted with the ethical principle of Declaration of Helsinki and consistent with GCP & regulatory environment  Clinical trial should be scientifically sound & describe in a clear detail protocol  The risk of patient should be less &benefit should be more
  •  All clinical trail information should be recorded handled & stored in way that allow its accurate reporting interpretation verification  Medical care of patient should be taken by qualified physician  Each individual involved in a clinical trial should be qualified by education training & experience  Before the start of clinical trial participation informed consent of every patient is necessary  Trial must be conducted to protocol that has received prior approval of an IRB/IEC
  • 1. Federal Food & Drugs act, 1906 2. Sulfanilamide Disaster, 1937 3. Food, Drug & Cosmetic act, 1938 4. The Nuremberg Code, 1948 5. Durham Humphrey Amendment, 1951 6. Thalidomide Disaster, 1951 7. Kefauver Harris Amendment 1962 8. Declaration of Helsinki, 1964 9. Medical Device Amendment, 1976 10. Good clinical practice (1980s1990s) 11. ICH-GCP, 1997
  • Medical research must..  Conform to generally accepted scientific principles & be based on thorough knowledge of scientific literature  Caution should be exercised in the conduct of research that may affect the environment  Welfare of the animals must be respected  Importance of the objective should outweigh 5risks & burden to subjects  Be described in a protocol  Be considered by an ethical review committee  Be conducted by scientifically qualified persons supervised by clinically competent medical person  Subjects must be volunteers & informed participants
  •  Physician must:  Protect the life,health,privacy & dignity of the human subject  Cease any investigation if the risks outweigh any potential benefits  Inform adequately each potential subject & obtain his/her freely given consent, preferably in writing  Obtain consent from a legally authorized representative if subject legally incompetent
  •  „A need was, however, felt to develop our own Indian Guidelines to ensure uniform quality of clinical research throughout the country and to generate data for registration for new drugs before use in the Indian population.‟