For a New Drug Application (NDA) drug Safety and Efficacy must be established. This often requires a randomized clinical trial. According to the FDA, all drugs, including brand-name and generic drugs, must be effective and safe. Generic drugs use the same active ingredients as brand-name drugs and therefore have the same risks and benefits. However, some generic drugs may be stronger or weaker than the drugs they mimic, release the dose into the bloodstream incorrectly, or contain impurities-sometimes with dangerous effects. To ensure quality, safety, and effectiveness, the FDA conducts a thorough review process for all generic drugs, including a review of scientific information about the generic drug's ingredients and properties. In addition, the FDA requires that generic drug manufacturing facilities meet the same high standards as brand-name drug facilities. Focusing on drug quality research and management for many years, Alfa Chemistry provides you with reliable generic drug safety evaluation services in accordance with FDA guidelines.
Alfa Chemistry's Services
Alfa Chemistry provides reliable and high-quality generic drug safety evaluation services, mainly through toxicological, pharmacological, and histopathological verification. Our state-of-the-art facilities, experienced team of scientists, and adherence to regulatory guidelines enable us to provide reliable and scientifically sound results.
Toxicological evaluation of generic drugs is an important part of drug safety evaluation. Alfa Chemistry has a dedicated team and hands-on experience in generic safety evaluation, providing high-quality data and fast turnaround times to support each generic drug toxicological study. Toxicology studies can be performed to non-GLP or GLP standards.
What we offer:
- In Vitro Toxicology Evaluation of Generic Drug
We provide a variety of efficient in vitro toxicity screening methods to assess the toxicity propensity and conformational relationship of generic drugs to assist our clients in generic drug selection and optimization. We ensure rapid and timely reporting of the results of multiple analytical methods and dose-dependent relationships, so that our clients can be informed of the potential toxicity of generic drugs as early as possible. - In Vivo Toxicology Evaluation of Generic Drug
Alfa Chemistry offers programmatic flexibility for in vivo toxicological evaluation in rodents and non-rodents. We can examine adverse effects by multiple routes of administration, determine the degree of toxicity and reversibility, and establish dose-effect relationships to assist clients in selecting doses for clinical trials and predicting genotoxicity.
Alfa Chemistry has developed a variety of animal models for pharmacological evaluation of generic drug. Each model is designed to understand various aspects of drug characterization and its mechanism of action. By examining our full range of capabilities, clients can develop cost-effective plans that reduce turnaround time and accelerate the generic drug submission process.
Our generic drug pharmacological evaluation platforms include:
- Safety Pharmacological Evaluation of Generic Drugs
- Additional and/or Supplemental Safety Pharmacological Evaluation of Generic Drugs
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. 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.
Service Contents:
- Specialized Histochemistry
- Immunohistochemistry
- Sections
- Disease Pathology
- Toxicologic Pathology
- Histomorphometry
