For samples that will be analyzed to meet GLP standards, the protocol must identify the collection time, the tests and the lab performing the analysis. It is best to also describe any sub-groups or differences between collection periods in the Clinical Pathology section of the protocol.
A few examples are provided to give an understanding of the detail to provide.
Clinical Pathology Evaluations
Clinical investigations (hematology, clinical chemistry, and urinalysis) will be conducted on 10
animals/group/sex at Week 6 and at termination. The order of bleeding and analysis will be alternating
(1 animal from each dose group, then repeating) in order to reduce handling and time biases. All blood
samples will be obtained from CO2/O2 anesthetized animals by puncture of the retroorbital sinus.
Animals will be fasted overnight (approximately 16 to 18 hours) prior to the bleeding procedures.
The exact time period the animals are fasted will be documented. Individual urine samples will be
collected in metabolism cages over a 24-hour period during the week prior to the terminal sacrifice.
Samples will be collected and stored as required for proper analysis. Samples will be sent by overnight
delivery to:
Antech Diagnostics
507 Airport Blvd. Suite 113
Morrisville, NC 27560
The following parameters will be determined:
Hematology:
Erythrocyte Count
Hematocrit
Hemoglobin
Mean Corpuscular Volume (MCV)
Mean Corpuscular Hemoglobin (MCH)
Mean Corpuscular Hemoglobin Concentration (MCHC)
Platelet Count
Total Leukocyte Count
Differential Leukocyte Count
Reticulocyte Count
Clinical Chemistry:
Alanine Aminotransferase (ALT)
Alkaline Phosphatase (ALK)
Aspartate Aminotransferase (AST)
Creatine Kinase (CK)
Gamma-glutamyl transerase (GGT)
Sorbitol Dehydrogenase (SDH)
Bilirubin, Total
Bilirubin, Direct; if Total Bilirubin >1.0 mg.dL
Bilirubin, Indirect (calculated)
Calcium
Creatinine
Total Protein
Albumin
Globublin (calculated)
Phosphorus
Sodium
Potassium
Chloride
Urea Nitrogen
Urinalysis
specific gravity
protein1
glucose1
ketones1
bilirubin1
blood1
urobilinogen1
total volume
color and appearance
microscopic elements
1 Semiquantitative dipstick method
If only a specific test is to be completed at Antech Diagnostics, please specify the
testing to be completed at Antech Diagnostics. Using the example above:
Clinical Chemistry:
Alanine Aminotransferase (ALT)
Alkaline Phosphatase (ALK)
Aspartate Aminotransferase (AST)
Creatine Kinase (CK)
Gamma-glutamyl transerase (GGT)
Sorbitol Dehydrogenase (SDH)
Bilirubin, Total
Bilirubin, Direct; if Total Bilirubin >1.0 mg.dL
Bilirubin, Indirect (calculated)
Calcium
Creatinine
Total Protein
Albumin
Globublin (calculated)
Phosphorus
Sodium
Potassium
Chloride
Urea Nitrogen
Thyroid Stimulating Hormone (TSH)2
Thyroxine (T4)2
Triiodotyronine (T3)2
* Clinical Chemistry tests can be performed on urine samples
as quantitative assays.
Anaylses to be performed at:
Antech Diagnostics
507 Airport Blvd., Suite 113
Morrisville, NC 27560
or
Urea Nitrogen
A separate 2.0 mL of blood will be collected and the serum sent to:
Antech Diagnostics, 507 Airport Blvd., Morrisville, NC 27560 for determination of the following parameters:
Thyroid Stimulating Hormone (TSH)
Thyroxine (T4)
Triiodotyronine (T3)
©2005 Antech Diagnostics, Inc.
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