CD Formulation is dedicated to ensuring the safety of nucleic acid drugs, particularly in terms of their potential effects on reproductive toxicity. We provide extensive reproductive toxicity study services, offering high-precision toxicity evaluations through scientifically stringent experimental methodologies and cutting-edge technical assistance. Our commitment is to aid clients in speeding up the development of safe and dependable drugs.

Why Conduct Reproductive Toxicity Studies?

Reproductive toxicity studies are a crucial part of evaluating the effects of compounds on the reproductive function and development processes of mammals through animal experiments. In the development of nucleic acid drugs, these studies hold great promise for predicting potential adverse effects on reproductive cells, the conception process, embryonic development, and even the growth of offspring. As nucleic acid drugs make breakthroughs in the medical field, these multi-layered toxicity evaluations lay a safe foundation for the clinical application of new drugs.

Explore Our Reproductive Toxicity Study Services for Nucleic Acid Drugs

CD Formulation, with many years of experience in toxicological research, provides accurate and stable reproductive toxicity assessments for clients at home and abroad with a professional technical team and internationally standardized laboratory environment.

General Reproductive Toxicity Tests (Phase I)

In this phase, we carefully design drug administration to experimental animals before mating to thoroughly investigate the potential impacts of drugs on reproductive cells. By assessing conception ability and the health status of the reproductive system, we explore whether the drug poses long-term impacts on the development of offspring.

Teratogenic Sensitivity Toxicity Tests (Phase II)

Teratogenic sensitivity studies aim to use precise administration strategies during critical stages of organogenesis to evaluate potential embryotoxicity of drugs on embryos. Using advanced imaging and biological testing tools, we identify possible structural deformities or functional abnormalities to ensure the safety of new drug development.

Perinatal and Reproductive Function Tests (Phase III)

Focusing on dosing schemes around the perinatal and lactation periods, we assess the sustained impact of drugs on maternal health and the development of the new generation. Through detailed behavioral and physiological tests, we ensure comprehensive understanding of the possible changes in reproductive capacity at different growth stages caused by the drug.

Customized Services

Combining specific customer needs, we provide customized study plans for nucleic acid drugs to ensure that testing processes and research data are highly relevant. Through personalized services and scientific support, we help clients obtain targeted and practical research conclusions.

Requirements for Reproductive Toxicity Studies

Testing Methods for Reproductive Toxicity Studies

• Dose Group Injection Method

Drugs are administered subcutaneously according to set dose groups, observing the effects of each dose on biological markers.

• Around Mating and Pregnancy Time

Administer drugs 60 days before mating for male rats, 14 days before mating, and 20 days after pregnancy for female rats to ensure comprehensive evaluation of reproductive and developmental functions.

• Observation Indicators

Detailed records of body weight changes, pregnancy rates, fetal condition (such as the number of dead and live fetuses, weight, and appearance, etc.) compared with a saline control group.

Workflow of Reproductive Toxicity Studies Services for Nucleic Acid Drugs

Fig.1 Flow chart of reproductive toxicity studies for nucleic acid drugs. (CD Formulation)

• Experimental Design

Through an in-depth preliminary planning stage, we work closely with customers to fully understand research goals and specific needs.

• Preparation of Experimental Conditions

After confirming the experimental design, we fully prepare the experimental conditions, from regulating the experimental environment to calibrating trial equipment and preparing materials, ensuring the experiment is conducted under highly controlled conditions.

• Data Collection

During the experiment, we use professional technical equipment for precise data collection and conduct in-depth data analysis using complex analytical tools.

• Report Generation

After the experimental phase is completed, we compile a detailed experimental report covering all research methods, data results, and analysis discussions.

Our Advantages of Reproductive Toxicity Studies Services

• Expert Team - Led by seasoned reproductive toxicity scientists, ensuring scientific depth in research.
• High Standard Laboratory Environment - Jointly established with internationally renowned toxicological research institutions, complying with international standards.
• Precise Instrument Configuration - Equipped with world-class laboratory equipment to ensure precision and reliability in research.
• Comprehensive Resource Allocation - Complete resources and platforms offering one-stop services from experimental design to result analysis to maximize experimental efficiency.

Publication Data

By deeply exploring the reproductive toxicity of nucleic acid drugs, CD Formulation helps clients take the initiative in new drug development, promoting pharmaceutical innovation. Our services not only provide compliance safety guarantees but also enhance efficiency throughout the R&D process. Feel free to contact us anytime, so we can jointly open a new chapter in pharmaceutical R&D and achieve a win-win in scientific and commercial value.