Simulating Real-World Conditions for Reliable Product Evaluation

Neopharm specializes in in-use studies, designed to assess the performance, safety, and stability of your products under real-world conditions.

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Our skilled team specializes in protocol design and execution of in-use studies for multidose products, including container openings, powder reconstitution, and solution dilution. By replicating hospital and pharmacy settings, we provide valuable insights into the product's behavior and ensure its optimal use. 

Additionally, our studies can be conducted in controlled climatic conditions to mimic the actual conditions of use, ensuring accurate and reliable results. 


Real-World Product Testing Made Easy

Understanding how products perform in real-world scenarios is crucial for ensuring their effectiveness and safety. Our in-use studies simulate actual usage conditions, providing valuable data on factors such as stability, functionality, usability, and microbial contamination risks. This enables you to optimize product formulations, packaging, and instructions for use, leading to improved patient outcomes and enhanced product quality.

Tailored Protocols for Optimal Results

At Neopharm, we understand that different products have unique usage patterns and requirements. Our in-use studies are tailored to your specific needs, whether it involves multidose container openings, powder reconstitution, or solution dilution. By customizing the study design and execution, we provide insights that are directly applicable to your product, ensuring accurate evaluation and actionable recommendations.

Analyses of Multidose Products

Our team has extensive experience in analyzing multidose products for efficacy, safety, user experience, and more. We can provide insights into how your product performs under different conditions and how it can be improved.

Compliance with Regulatory Requirements

In-use studies play a vital role in meeting regulatory requirements for pharmaceuticals, vaccines, and medical devices. Our team is well-versed in developing protocols that align with regulatory guidelines, ensuring that your studies are conducted in accordance with industry best practices. By generating reliable and comprehensive data, we help you demonstrate compliance and expedite the regulatory approval process.

Neopharm Answers to Common Questions About In-use Studies

In-use studies are applicable to various products, including pharmaceuticals, vaccines, biologics, and medical devices. They are particularly valuable for multidose products that require repeated opening, reconstitution, or dilution. Our expertise covers a wide range of formulations, including liquids, powders, suspensions, and injectables.

Our in-use studies are designed to closely mimic real-world conditions, particularly in hospital and pharmacy settings. We create a controlled environment that replicates relevant factors such as temperature, humidity, handling practices, and exposure to microbial contaminants. By simulating these conditions, we generate data that accurately reflects product performance and stability in actual usage scenarios.

Yes, we can execute in-use studies in various climatic conditions to mimic the actual conditions of product use. Our expertise includes conducting studies within the ICH climatic long-term world zones, such as 25°C/60%R.H., 30°C/65%R.H., and 30°C/75%R.H. These conditions help evaluate product performance and stability under the specific temperature and humidity profiles encountered in different geographical regions.

In-use studies provide valuable insights into product behavior, functionality, and safety in real-world scenarios. The data generated from these studies can be used to optimize product formulations, packaging designs, and instructions for use. By identifying potential issues and improving product usability, you can enhance patient satisfaction, reduce risks, and ensure regulatory compliance.

Enhance your product's performance and usability with Neopharm's comprehensive In-use Studies. Our protocol design, execution expertise, and customized approach ensure accurate evaluation under real-world conditions. Contact us today to discuss your specific needs and take a crucial step towards product optimization and regulatory compliance.

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