Toxicological Evaluation of Generic Drug

Toxicology studies are an important part of the non-clinical safety evaluation of generic drugs. Preclinical toxicology data help us to understand the toxicological profile of generic drugs, so that we can carry out a scientifically sound design and provide an important basis for the development of clinical trials of the drug to minimize the side effects or clinical risks, which is crucial for generic drugs. As part of the generic drug safety evaluation, they need to demonstrate that the test compound is safe for human administration and at what dose. 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.

Figure 1. An overview of machine learning and big data for drug toxicity evaluation. (Vo A H, et al. 2019)

Our Capabilities

• GLP Preclinical Research
• IND Enabling Research
• TK/PK Screening
• DRF and MTD Studies
• Subacute and Chronic Toxicity
• SPF Class Laboratory Animal Area
• Legal and Regulatory Assurance
• Small and Large Animal Models
• Alternative Dose Routes
• Clinical Bioassays

Alfa Chemistry's Services

Alfa Chemistry is dedicated to providing in vitro and in vivo toxicology evaluation services of generic drugs. We begin your safety and toxicology program with a robust strategy to anticipate problems and avoid costly delays.

In Vitro Toxicological Evaluation of Generic Drug

We offer a variety of highly effective in vitro toxicity screening methods to evaluate the propensity for toxicity and conformational toxicity relationships of generic drugs to help our clients with selection. We ensure that the generic drugs provided by our clients can be rapidly tested for in vitro safety with a minimum of 10 uL of compounds at a concentration of 10 mM. Most assays are based on high-throughput screening systems with low compound dosages and short data feedback cycles (typically within one week).

In Vivo Toxicological Evaluation of Generic Drug

We offer flexible in vivo toxicological evaluations of generic drugs in rodents and non-rodents to examine adverse effects by multiple routes of administration, to determine the extent and reversibility of toxicity, and to establish dose-effect relationships to assist clients in selecting doses for clinical trials and predicting genotoxicity. We can perform clinical indication observation, histopathology analysis, gross observation, clinical biochemistry analysis, hematology testing, and urinalysis, etc.

Service Items

Our generic drug toxicology evaluation services include but not limited to:

• Single dose toxicity test
• Repeated dose toxicity test
• Safety pharmacology tests: central nervous system studies, cardiovascular system (telemetry and non-telemetry in dogs and monkeys), respiratory system
• Genotoxicity test
• Reproductive toxicity test: fertility and early embryo developmental toxicity test (reproductive stage I), embryo-fetal developmental toxicity test (reproductive stage II)
• Immunogenicity test
• Toxicokinetics
• Local toxicity test (hemolysis, allergy, irritation test)

Application of Generic Drugs Toxicological Evaluation

• Preclinical safety evaluation of generic drugs
• Procedures for preclinical evaluation of generic drug toxicity
• Safety of APIs and excipients
• Toxicology study declaration information