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RUSHALI PATEL JUNE-JULY 2015 AHMEDABAD INTERNATIONAL SCHOOL
PRESENTATION OVERVIEW
BIO EQUIVALENCE STUDY IN CLINICAL RESEARCH
09:30 10:00
10:00 10:30
BABE STUDY. 2
INTRODUCTION
BIO EQUIVALENCE STUDY IN CLINICAL RESEARCH
ON WHOM
04 The study involves healthy volunteers in which the objective is to compare the two formulations of different
manufacturers or two different batches of same manufacturers to determine its BABE
BABE STUDY. 3
PRACTICES FOLLOWED
PRACTICES FOLLOWED
BIO EQUIVALENCE STUDY IN CLINICAL RESEARCH
Project that brings together the regulatory Quality Standard provided by ICH, A set of principles that provide a
authorities of Europe, Japan and the Schedule Y, Indian GCP to regulate clinical framework within which laboratory studies
United States and experts from the trials involving human subjects are planned, performed, monitored,
pharmaceutical industry to discuss reported and archived.
scientific and technical aspects of Given by OECD, WHO, 21 CFR part 58,
pharmaceutical product registration Purpose: Schedule L1
Enforce tight guidelines on ethical aspects
of a clinical study
Purpose: Purpose:
Guidelines include protection of human
More economical use of human, animal rights for the subjects and volunteers in a Help improve quality of data and reports
and material resources clinical trial and increases the confidence in validity of
To eliminate unnecessary delays in test reports.
Provides assurance of the safety and
availability of new medicines Key players:
efficacy of the newly developed
To produce a single set of technical compounds Management, Study Director, QA,
requirements for the registration of new Key Players: Personnel
drug products to streamline development
Investigators, Ethics Committee, Sponsor,
QA)
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INDEPENDENT ETHICS COMMITTEE
BIO EQUIVALENCE STUDY IN CLINICAL RESEARCH
COMPOSITION
An independent body (a review board or a committee: institutional, regional,
national or supranational) constituted of medical professionals and non
medical members
RESPONSIBILITIES
Ensure protection of rights, safety and week being of human subjects
involved in a trial
Provide public assurance of that protection by reviewing and approving/
providing favorable opinion on trial protocol
Ensure suitability of investigator, facilities and methods, and material to be
used in obtaining and documenting informed consent of trial subjects.
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IHC-GCP Principles
BIO EQUIVALENCE STUDY IN CLINICAL RESEARCH
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DEPARTMENTS INVOLVED
DEPARTMENTS INVOLVED
BIO EQUIVALENCE STUDY IN CLINICAL RESEARCH
QA/QC DEPARTMENT
Compliance, Quality Improvement and Staff Training
BIOMETRICS DEPARTMENT
Pharmacokinetic and Statistical Analysis, Bio Equivalence Established
CLINIC
Cannulation, Feeding Subjects, Dosing, Blood Collection, Centrifugation
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CLINIC
BIO EQUIVALENCE STUDY: DEPARMENTS INVOLVED
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BIO ANALYTICAL LAB
BIO EQUIVALENCE STUDY: DEPARMENTS INVOLVED
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BIOMETRICS DEPARTMENT
BIO EQUIVALENCE STUDY: DEPARMENTS INVOLVED
PHARMACOKINETIC BIOSTATISTICS
S (OR BIOMETRY)
Branch of pharmacology Application of statistics to a
dedicated to determining the wide range of topics in
fate of substances biology.
administered externally to a Design of biological
living organism experiments, especially in
Involves Absorption, medicine, pharmacy,
Distribution, Metabolism and agriculture and fishery
Excretion Collection, summarization,
and analysis of data from
those
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QUALITY ASSURANCE/QUALITY CONTROL
BIO EQUIVALENCE STUDY: DEPARMENTS INVOLVED
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ARCHIVE DEPARTMENT
BIO EQUIVALENCE STUDY: DEPARMENTS INVOLVED
ARCHIVAL
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MEDICAL WRITING DEPARMENT
BIO EQUIVALENCE STUDY: DEPARMENTS INVOLVED
MEDICAL WRITING
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BABE STUDY
AS IT HAPPENED
IN REAL LIFE
BABE STUDY
AS IT HAPPENED IN REAL LIFE
STEP 6
REPORTING
STEP 5
STATISTICAL
STEP 4
ANALYTICAL
STEP 3
CLINICAL
STEP 2
CHECKIN
STEP 1
SCREENING
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SCREENING
BABE STUDY: AS IT HAPPENED IN REAL LIFE
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CHECKIN PROCESS
BABE STUDY: AS IT HAPPENED IN REAL LIFE
ATTENDANCE
1. CHECKIN STARTS
Attendance taken
(Documented in Subject
Arrival Record) ICF
2. INFORMED CONSENT
FORM
ICF issued and subjects
given ample time to read it
PROTOCOL
3. PROTOCOL PRESENTATION
Details about expected
Blood loss and
compensation provided
TRIAL CONSENT
4. TRIAL CONSENT
TAKEN taken
Trial consent
(Video recording of
Consent)
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ALCHOHOL
TEST
5. ALCHOHOL TEST
Digital Alcohol Detector/
Breathalyzer
DRUG ABUSE
TEST
6. DRUG ABUSE TEST
Detector Urine Test to
check for Drug Abuse
VITALS
CHECKED
7. MEDICAL EXAM
Vital Stats, Blood
pressure etc. checked)
COMPLIANCE
CHECK
8. COMPLIANCE CHECK
Basic questions asked to
subject to ensure
compliance
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NUMBER ALLOTED
9. SUBJECT NUMBER
ALLOTED
FINAL CHECKIN
01 CANNULATION is done in order to minimize punctures and pain to subject at each time of blood
collection. A tube (cannula) is placed inside a vein to provide venous access. (takes place 75
minutes before dosing)
02 FOOD PROVIDED depending upon whether fasting or fat study. Meals are provided in order of
number allocated to subjects. Necessary to ensure that all the food provided is completed as fat
study. Subjects which are unable to digest the food and vomit are discontinued. They are
replaced with extra subjects.
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CLINICAL PROCESS
BABE STUDY: AS IT HAPPENED IN REAL LIFE
04 BLOOD COLLECTION After cannulation is over, blood collection starts in the same order. 2 minute interval between the blood
collection of each subject. 0.5 ml of heparinized blood is discarded prior to the collection of each blood sample. Blood sample is
collected and placed into appropriately labeled vacuette.
05 CENTRIFUGATION of the blood samples is then carried out to separate plasma from the blood as the drug is present in the
plasma. Centrifugation is carried out at 3000 revolutions per minute for 15 minutes and at 4 degrees Celsius. A pipette is then
used to transfer the separated plasma from the vacuettes to appropriately labeled RIA vials. Placed into 2 duplicate RIA vials (1 is
for backup).
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ANALYTICAL PROCESS
BABE STUDY: AS IT HAPPENED IN REAL LIFE
01 METHOD DEVELOPMENT A specific extraction and instrument process is decided and planned for each specific molecule (drug)
to be analyzed.
02 METHOD VALIDATION To ensure that the method developed produces accurate and precise results. A lot of parameters are
validated: Accuracy, Precision, Selectivity , Stability , Matrix Effect
PIPPETTES LIQUID
03 A lab tool commonly used in the lab to
transport a measured volume of liquid often
04 Used for the separation of molecules present
CHROMATOGRAPHY
in plasma
as a media dispenser.
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STATISTICAL PROCESS
BABE STUDY: AS IT HAPPENED IN REAL LIFE
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SPECIAL THANKS TO
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GLOSSARY OF TERMS
BABE STUDY: AS IT HAPPENED IN REAL LIFE
CRO: Contract Research Organization BAC: Blood Alcohol Concentration SAE: Serious Adverse Event
IEC: Independent Ethics Committee IP: Investigational Product CFR: Court of Federal Regulation
SOP: Standard operating procedure QA: Quality Assurance CRC: Central Report Compilation
CRF: Case Report Form QC: Quality Control IS: Internal Standards
GCP: Good clinical Practice AP: Analytical Procedure ULOQ: Upper Limit of Quantitation
GLP: Good Laboratory Practice ICH: International Conference on Harmonization LLOQ: Lower Limit of Quantitation
MSR: Medical Screening Record IRB: Institutional Review Board BLQ: Below limit of Quantitation
ECG: Electro Cardiogram LAR: Legally Acceptable Representative ALQ: Above Limit of Quantitation
ICF: Informed Consent Form ICMR: Indian Council for medical research CC: Calibration Curve
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