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RDC 894 - Guide To Protocol and The Technical Report BA - Be

Resolution RE n º 894, issued on May 29, 2003, establishes guidelines for the preparation of bioequivalence study protocols. It includes detailed requirements for study design, population, ethical considerations, and analytical methods. The resolution also repeals a previous resolution and comes into effect upon publication.

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10 views2 pages

RDC 894 - Guide To Protocol and The Technical Report BA - Be

Resolution RE n º 894, issued on May 29, 2003, establishes guidelines for the preparation of bioequivalence study protocols. It includes detailed requirements for study design, population, ethical considerations, and analytical methods. The resolution also repeals a previous resolution and comes into effect upon publication.

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satyam.ghag
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Resolution - RE n º 894, of May 29, 2003

The Deputy of the Board of the National Agency for Sanitary Surveillance, the use
the assignment, which gives Ordinance No. 238 of March 31, 2003,
considering the provisions of Article 111, item II, letter "a" § 3 of the Bylaws
approved by Presidential Decree No. 593 dated August 25, 2000, republished in the Official
Gazette of 22
December 2000 that the matter was referred to the Board that the
adopted at a meeting held on March 6, 2003, resolves:
Art.1 determine the publication of "A Guide to Protocol and the technical report of study
bioequivalence ", attached.
Article 2 is repealed Resolution RE n. 479, of March 19, 2002.
3 This resolution enters into force upon its publication.
DAVID RUMEL
ANNEX GUIDE FOR PREPARATION OF BA/BE PROTOCOL

Relative bioavailability / bioequivalence


1. Project Title (should contain the drug name, dosage, dosage form and
the name of manufacturer of test and reference drug).
2. Number and date of the protocol.
3. Principal investigator (researcher in charge).
4. Clinical investigator (must necessarily be a physician).
5. Responsible for the analytical phase.
6. Responsible for the statistical phase.
7. Facilities (name and address):
7.1. Clinical stage;
7.2. analytical phase;
7.3.etapa statistics;
7.4. clinical evaluation;
7.5. clinical laboratory tests.
8. Purpose of the study.
9. Study design:
9.1. type;
9.2. identification of the test and reference drug: drug name, name
brand name (if applicable), dosage form, dosage per unit, name and address of
manufacturer, batch number, manufacturing date and expiration date (when available);
9.3. dosage: dose, schedule and volume of liquid for administration;
9.4. location and housing of volunteers;
9.5. hours of fasting and feeding;
9.6. timing of sample collection;
9.7. procedures for handling the samples.
10. Study Population:
10.1. detailed description (sex, age, weight, height);
10.2. subject selection:
10.3. clinical evaluation (medical history and physical examination);
10.4. clinical laboratory tests: electrocardiogram, hematological,
biochemistry (including liver function tests and kidney), serological (hepatitis B,
Hepatitis C, HIV), beta-HCG (for women) and urinalysis;
10.5. inclusion criteria;
10.6. exclusion criteria;
10.7. restrictions and prohibitions: before, during and after the study;
10.8. criteria for discontinuation or withdrawal from the study.
11. Adverse reactions (including method of assessment) and procedures
emergency.
12. Ethical considerations:
12.1. basic principles - must follow the current resolutions of the National
Health-Ministry of Health (CNS / MS), which regulate the standards of research
humans.
13. Analytical Method:
13.1. description;
13.2. validation protocol.
14. Statistical treatment:
14.1. present study design, as the "GUIDE FOR PLANNING AND IMPLEMENTATION OF
STEP STATISTICAL FOR BA/BE.
Relative bioavailability / bioequivalence;
14.2. justify the sample size in the study;
14.3. definition of the acceptance range of pharmacokinetic parameters to be
tested in the study, according to the "GUIDE TO TESTS
Relative bioavailability / bioequivalence;
14.4. specify the method for outlier detection.
15. Acceptance criteria of protocol deviations (eg: deviation from
collection, etc.)..
16. Appendices:
16.1. form for retention samples (must report the number of units of
test and reference drug that must be withheld, enough to repeat the
test. These samples should be stored in appropriate conditions to preserve
unique features of the products until the expiration of its validity);
16.2. form for the inventory of drugs used in the study (due to
report the number of units of test and reference drugs used in
test, and any loss incurred);
16.3. term model of informed consent;
16.4. registration form of adverse events;
16.5. randomization list.
OBS.: All pages of the document must contain: name of the center, number of
protocol and sequential numbering.

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