Histopathological Evaluation of Generic Drug

In the diagnostic process, diagnostic histopathological analysis is considered the gold standard for determining the presence and nature of disease. Before the organism shows obvious clinical symptoms, the effects of drugs on organs, tissues, or cells of the organism can be detected through histopathological testing, providing a reference for the prevention and treatment of diseases. In the process of generic drug declaration, each relevant organization can judge the potential hazard level of the declared generic drug through the histopathological diagnosis results. Guidelines issued by various regulatory agencies require histopathological diagnosis in tests for short-term toxicity, sub-chronic toxicity, chronic toxicity, and carcinogenicity, which is an important part of the safety assessment of generic drugs. Alfa Chemistry provides generic drug histopathology evaluation services to help determine the effects of generic drugs on tissues and organs in accordance with FDA guidelines.

Our Capabilities

• Routine H&E staining
• Specialty stains: Periodic Acid Stain (PAS), Masson's Trichrome, Silver Stain, PAM, Sirius Red, Sudan Red III, and other specialty stains as requested
• Immunohistochemical staining (IHC)
• Immunofluorescence chemical staining (IF)
• Immunocytochemical staining (ICC)
• In Situ Hybridization (ISH)
• Fluorescence in situ hybridization (FISH)

Histopathological Evaluation Services

Alfa Chemistry has a broad and comprehensive range of skills and expertise and pathology evaluations that we can offer our clients in histology, toxicopathology, and disease pathology. We emphasize the extent and complexity of any morphological changes in the tissue sections examined. The grading of severity is based solely on the morphologic changes observed, ensuring transparent and consistent reporting of results. We balance the need for detailed information with practical considerations, utilizing a flexible and comprehensive grading scale for daily assessment.

Service Contents:

• Specialized Histochemistry
• Immunohistochemistry
• Sections
• Disease Pathology
• Toxicologic Pathology
• Histomorphometry

Alfa Chemistry's Scientific Histopathological Evaluation Process

Figure 1. Decision tree for use of detailed
grading criteria. (Schafer K A, et al. 2018)

Our procedures encompass the preparation of paraffin and frozen sections, staining, and evaluation of completion, and we communicate closely with our clients to ensure that our histopathology studies are of the best quality possible.

Sample collection and preparation

• Samples are carefully extracted to ensure that damage is minimized
• Preparation involves fixation, which is the process of preserving the tissue in a substance (usually formalin) to prevent decay and maintain cellular structure

Tissue processing and embedding

• Dehydration of tissue samples using alcohol
• Cleaning using a substance such as xylene to make them clear and ready for the embedding stage
• Embedding involves placing the tissue in a medium such as paraffin to provide firm support for the sections

Sectioning and staining

• The embedded tissue is cut into thin slices using a slicer. These thin slices allow detailed examination of the tissue structure under a microscope
• The sections are stained to highlight the different structures within the tissue

Microscopic examination

• Stained sections are examined under a microscope to ensure a detailed view of the examined tissue

Grading and reporting

• Severity grades are assigned based on the degree and complexity of morphological changes observed in the examined tissue sections
• We ensure transparency and consistency in reporting to ensure that the findings are clear and easy to understand.

Our Advantages

• We accept a wide variety of animal tissues, including but not limited to rats, mice, guinea pigs, rabbits, dogs, non-human primates, and mini-pigs
• We provide active exploration methods and solutions for special tissue organs to fully satisfy our customers' needs
• Many different staining techniques are available
• State-of-the-art equipment, including OLYMPUS light microscopes and Leica Aperio GT450 scanners, facilitates high-resolution, detailed observation of examined tissues
• Extensive diagnostic experience with many types of toxicity study tests, including short-term toxicity tests, sub-chronic toxicity tests, chronic toxicity tests, and carcinogenicity studies