Safety Pharmacology Evaluation

All new oligonucleotide therapeutics must undergo nonclinical safety testing prior to the initiation of human clinical trials. A critical component of this process is the conduct of safety pharmacology evaluation, which is a branch of pharmacology specializing in characterizing drug-related changes in the cardiovascular, central nervous, and respiratory systems to ensure that a drug candidate is safe for human use before it progresses to clinical trials.

The safety pharmacology evaluation of oligonucleotide therapeutics requires a scientific and context-specific approach, as each biological model possesses unique pharmacological characteristics that influence the overall nonclinical safety assessment strategy. Alfa Chemistry has a professional technology platform for safety pharmacology evaluation, and our evaluation is based on The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines S6R1 and S7. If you need help, please contact us.

Purpose of Safety Pharmacology Evaluation

The purpose of nonclinical safety pharmacological evaluation is threefold:

• Protect Phase I clinical trial volunteers from acute adverse effects of drugs.
• Protect patients, including those participating in Phase II and Phase III clinical trials.
• Minimize the risk of failure during drug development and post-marketing phases.

Species Selection of Safety Pharmacology Evaluation

In selecting the species for safety pharmacology evaluation of oligonucleotide therapeutics, the following points be taken into consideration:

• The relevance of the model.
• The responsiveness of the species to the intended pharmacologic activity of oligonucleotide therapeutics.
• The similarity in target distribution between the species and humans.

What We Offer?

With experienced experts and state-of-the-art equipment, Alfa Chemistry is able to provide customers with safety pharmacology evaluation services and related technical advice for oligonucleotide therapeutics. We are committed to:

Our products and services are for research use only and cannot be used for any clinical purposes.

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