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Preclinical Development – Safety Assessment 2017-05-16T17:09:04+00:00

Safety Assessment

Preclinical safety assessment services are conducted to determine the degree to which your drug candidate will be tolerated. Initial evaluation includes determination of the maximum tolerated dose for single and repetitive administration based on route and schedule of interest, which is key for further pre-clinical evaluation of drug candidates.

Toxicology

Buffalo BioLabs offers a range of non-GLP rodent toxicology services in mouse and rat to assist in your preclinical drug development program.

Acute, subacute, subchronic, and chronic toxicity testing is performed as single or repetitive dosing for the determination of maximum tolerated dose (MTD), No Observable Effect Level (NOEL), and optimal dosing schedule.

Multiple routes of administration are available, including:

  • Oral
  • Topical
  • Subcutaneous
  • Intravenous
  • Intraperitoneal
  • Intramuscular
  • Intravesical

Necropsy

Necropsy is performed upon request to record gross morphological changes at the conclusion of the in-life portion of an animal study. Tissue collection can be performed from simple snap frozen methods to specialized collections (e.g., organ perfusion, bodily fluid (e.g., blood, urine, feces, ascites), formalin fixed). Routine services for tissue trimming, embedding, preparation of slides of paraffin- or cryo-sections, and H&E and custom IHC are available.

Pathology Services

Buffalo BioLabs offers traditional toxicologic pathology services from diligently trained and experienced technicians careful to adhere to all SOPs and study protocols and ensure all samples are labeled, catalogued, and properly stored for additional evaluation or shipment to the Sponsor.

Pharmacokinetics/Pharmacodynamics

PK/PD studies can help you better understand the in vivo response to your drug candidate or how your drug is processed. Various routes of administration, dose schedules, and collection schedules are available as well as method development and sample analysis.

In Vitro Toxicity

In vitro toxicity assays can measure cytotoxicity, viability, and proliferation as an early indicator of cell health in response to the presence or absence of toxic properties of drug candidates. In vitro assays can save time and money by enabling the investigator to eliminate toxic compounds early in drug development, without the use of research animals, and help to avoid late stage failures.  Additionally, these types of assays can aid in the evaluation and potential optimization of drug concentration ranges as they relate to toxicity.

Cytotoxicity/ Cell Viability/Proliferation Assays

Cytotoxicity or cell viability assays and proliferation assays can be used with a panel of cell lines to assess a drug’s effect on cell viability and growth. Dose-response assays enable the determination of the IC50/LC50/EC50, which provides an indication of the strength of the effect on cells and allows the ranking of compounds when a panel of candidates are evaluated. These assays can examine the number of cells, cell proliferation, pr0liferation rates, and live/dead ratios using a number of readouts, and can determine the specificity of the effect for particular cell types (e.g., cancer versus normal). Various readouts are available. Please contact us for details!

Colony Forming Assays / Clonogenic Assays

Unlike cytotoxic assays that provide an aggregate readout of all proliferating cells and cell types within a culture, clonogenic assays can be used to evaluate the survival and proliferation of cells based on the ability of a single cell to grow into a colony in the presence of the toxic substance. Clonogenic assays are often applied to oncology research to understand the effect of drugs or radiation on proliferating tumor cells. In addition to assessing changes in proliferation, changes in differentiation potential in response to stimulatory, inhibitory or toxic agents can also be addressed through morphological assessment. Individual colonies can be isolated from the cell population for genomic or phenotypic analysis.

Ex Vivo Peripheral Blood Nucleated Cell Assays

Toxic agents are sometimes detrimental to blood cell populations (e.g. neutropenia). By performing cytotoxicity assays with freshly prepared PBNCs, we can determine whether drug candidates adversely affect critical blood cell parameters. In addition, the effects of drug candidates on specific cytokine levels can be explored.