Efficacy Study and Muscle Action Potential (CMAP) of Novatox 100U

This product's efficacy study involves a thorough assessment of its impact on Compound Muscle Action Potential (CMAP). Administered to a single muscle, it demonstrates varying degrees of contraction suppression and muscle palsy effects based on concentration. Notably, it matches the effectiveness of the renowned Botox liquor, maintaining muscle contraction inhibition at specific doses (5 units/kg).

1-Clinical Sample Production: Meticulously produced clinical samples undergo rigorous testing, ensuring quality, safety, and efficacy before advancing.

2-Clinical CRO Selection: We collaborate with experienced Clinical Contract Research Organizations (CROs) to ensure reliable and accurate study results.

3-IND Document Submission/Examination/Approval: Detailed Investigational New Drug (IND) documents are submitted for regulatory examination, providing comprehensive information on safety, preclinical data, and clinical trial protocols.

4-Permission for Export: Our product gains international regulatory approval, meeting export standards and accessing a broader global market.

1(a)Clinical Trials (Phase I and II): Comprehensive Phase I and II trials assess safety, efficacy, tolerability, dosage, and potential side effects in human participants.

5)KGMP License: Possession of the Korean Good Manufacturing Practice (KGMP) license attests to adherence to stringent quality standards in manufacturing.

Manufacturing Process, Domestic Patents, and PCTs: Our manufacturing process, backed by domestic patents and Patent Cooperation Treaty (PCT) protection, ensures exclusivity.

Domestic Patent for Drying Process: A domestic patent safeguards our innovative drying process, optimizing product quality and stability.

          what are the Composition of Novatox 100U

Each vial comprises 100 units of Clostridium botulinum Toxin Type A (IHS), 0.5mg of Human Serum Albumin (EP), and 0.9mg of Sodium Chloride (EP). Strains identified with Clostridium botulinum ATCC 3502 guarantee consistent performance.

a-Securing Stable Production Process Technology: Efforts in simplifying the undiluted solution manufacturing process result in securing stable production process technology, ensuring consistent product quality.

b-High Purity Undiluted Solution: Proudly producing a solution with over 99% purity enhances efficacy and minimizes the risk of adverse reactions.

c-Low Incidence of Resistance: Our unique formulation leads to a significantly low resistance incidence within the same product group, emphasizing our commitment to lasting and effective results.

This product must be administered by a licensed personnel. Click here to shop now