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· Section II

9.1.1. A final report should be prepared for each study. In the case of short- term studies, a standardised final report accompanied by a study specific extension may be prepared.

9.1.2. Reports of Principal Investigators or scientists involved in the study should be signed and dated by them.

9.1.3. The final report should be signed and dated by the Study Director to indicate acceptance of responsibility for the validity of the data. 

· 58.185

(a) A final report shall be prepared for each nonclinical laboratory study.

(b) The final report shall be signed and dated by the study director.

· Section II

9.2 Content of the Final Report

The final report should include, but not be limited to, the following information:

· 58.185

(a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to, the following:

· Section II 9.2

1. Identification of the Study, the Test Item and Reference Item

a. A descriptive title;

b. Identification of the test item by code or name (IUPAC, CAS number, biological parameters, etc.);

c. Identification of the reference item by name;

d. Characterisation of the test item including purity, stability and homogeneity.

· 58.185 (a)

2. Objectives and procedures stated in the approved protocol, including any changes in the original protocol.

4. The test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics. 

5. Stability of the test and control articles under the conditions of administration.

· Section II 9.2

2. Information Concerning the Sponsor and the Test Facility

a. Name and address of the sponsor;

b. Name and address of any test facilities and test sites involved;

c. Name and address of the Study Director;

d. Name and address of the Principal Investigator(s) and the phase(s) of the study delegated, if applicable;

e. Name and address of scientists having contributed reports to the final report.

· 58.185 (a)

1. Name and address of the facility performing the study and the dates on which the study was initiated and completed.

10. The name of the study director, the names of other scientists or professionals, and the names of all supervisory personnel, involved in the study.

· Section II 9.2

3. Dates

Experimental starting and completion dates.

· 58.185 (a)

1. the dates on which the study was initiated and completed.

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· Section II 9.2

5. Description of Materials and Test Methods

a. Description of methods and materials used;

b. Reference to OECD Test Guideline or other test guideline or method.

· 58.185 (a)

6. A description of the methods used.

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· 58.185 (a)

7. A description of the test system used. Where applicable, the final report shall include the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification.

8. A description of the dosage, dosage regimen, route of administration, and duration.

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· 58.185 (a)

3. Statistical methods employed for analyzing the data.

· Section II 9.2

6. Results

a. A summary of results;

b. All information and data required by the study plan;

d. An evaluation and discussion of the results and, where appropriate, conclusions.

c. A presentation of the results, including calculations and determinations of statistical significance;

· 58.185 (a)

11. A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis.

· Section II 9.2

7. Storage

The location(s) where the study plan, samples of test and reference items, specimens, raw data and the final report are to be stored.

· 58.185 (a)

13. The locations where all specimens, raw data, and the final report are to be stored.

· Section II 9.2

9. A description of all circumstances that may have affected the quality or integrity of the data.

· 58.185 (a)

9.1.3. The extent of compliance with these Principles of Good Laboratory Practice should be indicated.

· Section II 9.2

4. Statement

A Quality Assurance Programme statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the Study Director and Principal Investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.

· 58.185 (a)

14. The statement prepared and signed by the quality assurance unit as described in Sec. 58.35(b)(7).

58.35 (b)

(7) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.

· Section II 9.2

9.1.2. Reports of Principal Investigators or scientists involved in the study should be signed and dated by them.

· 58.185 (a)

12. The signed and dated reports of each of the individual scientists or other professionals involved in the study.

· Section II

9.1.4. Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the Study Director.

9.1.5. Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report.

· 58.185 

(c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible.