Contract Laboratory has received the following Hematology Laboratory Test Requests which need to be fulfilled! These Laboratory Test Requests are received from a variety of sources ranging from start-up companies to large, multinational Fortune 500 corporations, international organizations, well-respected universities and government agencies that are actively seeking Independent, Third-Party Hematology Laboratories to perform their Hematology Testing, Analysis, Assays, Product Development, Scientific Research Experiments, Inspections, Certifications, and Engineering Projects. If you are a Hematology laboratory that would like more information on these Hematology projects, please visit our registration page or call toll us free 1-855-377-6821.
EMAI FDA GLP Contract Research Organization CRO needed for FDA GLP preclinical toxicology and Immunogenicity studies with primates where our products can
be evaluated by IV route, administrated daily during 12 weeks and 4 weeks of
We want evaluated comparatively two products with two level doses and a
control group. The number of animals per group would be 3
animals/sex/group. It would be evaluated Hematology/Biochemistry parameters.
Also, we want do toxicokinetics, immunogenicity and local tolerance
San Diego Clinical Laboratory needed for non-GLP blood testing. Hematology: 16 -20 samples
Parameters to include-
White Blood Cell Count (WBC) (Total and Differential)
Red Blood Cell Count (RBC)
Hemoglobin Distribution Width (HDW)
Mean Corpuscular Volume (MCV)
Mean Corpuscular Hemoglobin (MCH)
Total Leukocyte Count
Mean Corpuscular Hemoglobin Concentration (MCHC)
Red Blood Cell Distribution Width (RDW)
Platelet Count (PLT)
Reticulocyte Count (Absolute and Percent)
Differential Leukocyte Count and Percent
Serum Chemistry: 16-20 samples
Parameters to include-
Alanine Aminotransferase (ALT)
Aspartate Aminotransferase (AST)
Alkaline Phosphatase (ALP)
Urea Nitrogen (BUN)
Total Protein (TP)
Creatine Kinase (CK)
Preclinical Contract Research Organization needed for preclinical toxicology study of Interferon drug:
Toxicology Study: The study is required on 35 male Syrian golden hamsters using our interferon. This study is for 28-days toxicology study followed by a 7-days observation period. The main goal is to show the safety of our interferon alpha 2a with the reference product is essentially the same. The detailed protocol would be provided, Briefly it requires:
-Blood will be collected after 35 days for standard hematology and clinical chemistry.
-Animals will be observed for 35 days for signs of ill health,tier duration,and time of death.
-Pathology:At the end of study, surviving animals will be sacrificed and weighed. A gross necropsy will be performed on all animals in the study. If a necropsy cannot be preformed immediately after death, the animal will be refrigerated at temperatures low enough to minimize autolysis. Necropsies will be preformed within a window period of one to two days. Organ weights will be recorded immediately after necropsy.Liver, lung and kidney samples will be taken in 10% formalin for histopathology
-Laboratory analysis:Microscopic pathology,blood chemistry and hematology will be performed. Kinetic Study in Rat The study will compare the kinetics of Interferons (bio similar products) given sub-cutaneously using Wistar rat.The detailed protocols will be provided but briefly the requirements are:
-There will be 64 male wistar rats having two groups of 32.
-Eight animals, 4 in each group, will be anesthetized bled and terminated at each data point (pre -dose, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h and 144
-A post mortem will be done on all animals to confirm their health status.
-Blood in EDTA for plasma will be collected at pre -dose, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h and 144 h.
California FDA GMP Toxicology Laboratory needed for small molecule toxicity testing which will hopefully go to clinical study.
The non-clinical laboratory study is hopefully conducted in conformance with the U.S. Food and Drug Administration Good Laboratory Practice regulations, 21 CFR part 58.
Here is one toxicity study some lab did for us before. 24 rats of each sex (12/sex/group, 6/sex/sacrifice timepoint) were assigned to a dose group and a vehicle control group and administered new drug intravenously via the tail vein at 0 (vehicle only) and 400 ug/kg/day as a single dose on Study Day 0. Groups of 5 animals/sex were sacrificed on Study day 1 (24 hours) and 14 for evaluation of clinical pathology and organ toxicity.
The animals were monitored prior to the administration of the test article new drug and up to 14 days following the administration of the test article. Parameters monitored included comprehensive blood chemistry and hematology, body weight and temperature, food and water consumption, histopathology and daily clinical observation.
At last, we need a detailed and reproducible report on the survival (morbidity and mortality), body weights, food and water consumption, clinical pathology (hematology and clinical chemistry), pathology, gross pathology, organ weights, and histopathology.
Here is just a rough idea about what we want. This is not necessarily exactly what it should be. I'd like to talk details with you or your colleagues.
If ok, I need to have a quota for the test. By the way, Call me or email when you have some updates regarding to this.
FDA GLP Toxicology CRO needed for 28 Day Sub-Acute Oral Toxicity Study for dietary supplement / food. Full Clinical Pathology: Standard blood chemistries and hematology (as per FDA Redbook 2000).
Urinalysis: Once, concurrent with clinical pathology. Necropsy: Gross necropsy at termination; standard tissues and organs weighed. Histopathology as appropriate.
USA GLP Preclinical Contract Research Organization required for the following:
Physical examination - qualify the subject companion animals as healthy and cancer free; get body score/weight
Laboratory tests: Hematology, blood chemistry, thyroid function tests, fecal examination, urinanalysis
Blood collected and stored for genetic testing (aliquots) DNA
Tumor collected and cancer type verified
GLP Toxicology laboratory needed for in vivo toxicology of liposome vesicles
28 day screen
Immunogenicity (repeat-dose tox study)
Dose -Range Finding Toxicity
Expanded Single Dose Acute Tox
Toxicology laboratory needed for LD50, Acute toxicity, Repeat-dose toxicity testing an anti-cancer agent for toxicological studies in non malignant mice. Parameters to Measure:
1) death body weight, feed consumption
2) weights/ necropsy and histopathology of major organs,
3) hematology , serum clinical chemistry
4) lymph node assay, and humoral immune response
6) electrocardiographic evaluation
7) Gene Mutation Assays
Non-GLP toxicology laboratory needed for preclinical testing Hematology, Clinical Biochemistry and multiple tissue analysis for potential toxicology effect of peptide vaccines in New Zealand White rabbits. Groups include: Saline, Adjuvant control, low dose and high dose in male and female rabbits.
Toxicology laboratory needed for immunology and histopathology testing the effect of a nutritional supplement on the immune system of rats after challenge with T-dependent and a T-independent antigens. Analysis would include histopathology data of lymphoid organs, hematology, various cytokines and functional immune cell assays.
GLP toxicology laboratory for toxicity studies, ELISA immunogenicity, CD4/CD8 proliferation and differentiation assays. Mouse toxicity study of cellular therapeutic product, injected subcutaneously, 3 doses over 2 weeks, sacrifice 1 week later for histopath. 4 groups, 10 mice each. In addition to traditional assessments, including clinical chemistry and hematology, this study will need to include specialty assays: immunogenicity by ELISA and CD4/CD8 proliferation and differentiation assays (see testing requirements).