It is not easy to chose the right experimental protocol.
Are Technology Scientific permeation studies right for you?
Limitations and opportunities of our permeation studies.
Learn More About Permeation Studies
As a healthcare professional, you may have encountered the need for permeation studies at various stages of product development, from regulatory compliance to consumer awareness campaigns. However, choosing the right study design can be challenging, especially since laboratories may not fully disclose the limitations of their services. This can pose risks for your product’s journey to market.
We instead believe that open communication about the strengths and weaknesses of our services can only benefit both you and us in finding the best fit for your needs. We recognize that no service is perfect, and while we are proud of our expertise, we also acknowledge that our in vitro permeation studies may not be suitable for everyone, including you.
This guide is designed to help you determine whether our in vitro permeation studies are a good match for your specific needs.
Understanding the regulatory framework for your permeation studies
OECD No. 428
The OECD Guideline for the Testing of Chemicals, No. 428: Skin Absorption: In Vitro Method (2004), serves as a standardized approach for evaluating the absorption of chemicals through the skin. This guideline provides a comprehensive framework for conducting permeation studies, encompassing all the crucial steps involved, from study design and sample preparation to permeation experiments, analytical determination, data evaluation, and reporting. The information gathered from studies following the OECD 428 plays a vital role in assisting regulatory agencies in establishing exposure limits for chemicals and developing appropriate safety measures for consumers.
ICH Q2 (R1)
The ICH Q2 (R1) guideline: Validation of Analytical Procedures: Text and Methodology, provides a comprehensive framework for validating analytical procedures used in the development and manufacturing of medicinal and health products. This guideline aims to ensure that analytical methods employed in these critical areas are reliable, accurate, and reproducible, generating data that is consistent and trustworthy. To achieve this goal, the ICH Q2(R1) guideline systematically covers various aspects of analytical validation, including:
- Specificity.
- Accuracy.
- Detection Limit.
- Quantitation Limit.
- Robustness.
By adhering to the ICH Q2(R1) guideline, laboratories can perform reliable analytical tests that generate consistent and accurate data, fostering confidence in the quality and safety of medicinal and health products.
Commercial authorization for medicinal products
If your goal is to obtain commercial authorization for a medicinal product and you are in the EU, you will need to adhere to the regulatory framework set forth by the European Medicines Agency (EMA) in Europe (CHMP/QWP/708282/2018). In this case, you will require bioequivalence studies supported by in vitro permeation test (IVPT) or in vitro release test (IVRT). These studies must utilize human membranes from about 12 donors, with at least 2 replicates per donor. Additionally, the study must be validated according to ICH Q2. The laboratory conducting the testing must be approved by EMA for the European market and by FDA for the US market.
Commercial authorization for medical devices
If your goal is to obtain commercial authorization for a medical device, you will need to comply with the Medical Device Regulation (MDR) 2017/745, with a permeation study following OECD 428 and ICH Q2(R1), does not require human membranes or restrictions on the number of donors. However, the minimum number of repetitions for each permeation experiments is 4.
Permeation studies in product development
Permeation studies hold the key to developing topical products that not only meet customer needs but also surpass market expectations. These studies provide crucial insights into the absorption rates and penetration depths of active ingredients, empowering you to tailor formulations for optimal therapeutic efficacy while minimizing unwanted side effects.
By delving into the impact of formulation factors on permeation, you can ensure consistent active compound delivery and proactively identify potential stability issues. This comprehensive understanding of your product’s behaviour will streamline your development process, leading to safer, more effective topical formulations that solidify your reputation as an innovative industry leader.
Permeation studies for authoritative marketing campaigns
Imagine your marketing campaign educating your costumers about how your is more than normal product but a sophisticated device, meticulously crafted to deliver specific benefits to them. However, without proving them how effectively it interacts with their skin, they are left guessing what the difference between your and the others‘ products. This is where permeation studies step in, acting as scientific X-rays that unveil the inner workings of your formulation.
Think of it this way: your competitors are making bold claims about their products, but without scientific backing, these claims are merely empty promises. Permeation studies provide the experimental evidence you need to substantiate your product claims and set yourself apart from the competition.
Permeation studies illuminate the intricacies of your product’s interaction with the skin. They quantify the rate at which active ingredients penetrate the skin’s layers, revealing whether your formulation effectively delivers its benefits or provide a barrier effect on the surface.
With permeation studies in hand, you can confidently declare the true capabilities of your product, and you will be able to:
- Substantiate your product claims with scientific evidence.
- Differentiate your product from competitors lacking such data.
- Optimize your formulation for maximum efficacy.
- Ensure consistent product performance from batch to batch.
- Embrace permeation studies as the scientific cornerstone of your product development.Â
By unravelling how your formulation interacts with the skin, you enable your custumer to understand how and why your product truly stands out from the crowd.
Is the cost for permeation studies worth?
While the initial cost of permeation studies may appear significant, the long-term benefits far outweigh the expenses. These studies represent an investment in your product’s success, empowering you to make scientifically substantiated claims that resonate with consumers and fuel sales growth. Additionally, the data generated from these studies can serve as a valuable resource for developing future products with even greater efficacy.
By investing in permeation studies, you gain access to a wealth of insights that would otherwise remain hidden. These insights enable you to:
Make informed decisions about formulation design and optimization
Substantiate your product claims with irrefutable scientific evidence
Position your product as a leader in the market, differentiating it from the competition
Build consumer trust and loyalty through transparency and scientific credibility
Gather valuable data for future product development, ensuring continuous improvement
The return on investment for permeation studies extends beyond the immediate benefits of product success. The insights and data generated can be leveraged for years to come, guiding your product development strategy and solidifying your reputation as a brand committed to quality and innovation.
- Make informed decisions about formulation design and optimization.
- Substantiate your product claims with irrefutable scientific evidence.
- Position your product as a leader in the market, differentiating it from the competition.
- Build consumer trust and loyalty through transparency and scientific credibility.
- Gather valuable data for future product development, ensuring continuous improvement.
The return on investment for permeation studies extends beyond the immediate benefits of product success. The insights and data generated can be leveraged for years to come, guiding your product development strategy and solidifying your reputation as a brand committed to quality and innovation.
Is Technology Scientific the right partner for you?
We are not the right partner if you require IVPT or IVRT for bioequivalence studies of medicinal products.Â
We are the right partner if you require permeation studies for medical devices, product development and marketing.Â
We at Technology Scientific with over 20 years of experience in the field, have a proven track record of success in conducting these studies.
What you can expect from Technology Scientific permeation studies:
- Scientific excellence: We are a university spin-off, which means that we have access to the latest research facilities. We also have a team of experienced scientists who are experts in their field. This ensures that your permeation studies will be conducted to the highest standards.
- Project management prowess: We have a proven track record of success in managing complex research projects. We will work closely with you to ensure that your study is completed on time and within budget.
- Technology transfer expertise: We can help you to seamlessly transition research findings into commercial products. This will help you to bring your products to market faster.
Technology Scientific is the SME born as an
 academic spin-off
our in vitro
permeation studies are used by
top companies and startups
Permeation study Packages Pricing
Every study includes
- Bibliographic research experimental protocol.
- Design, according to OECD guidelines.
- Franz cell selection, cell geometry.
- Membranes, artificial or ex vivo (animals).
- Test execution and permeation evaluation.
- Drafting of the report and delivery.
Development
1 analyte in 1 formulation
€ 3500
Updates: in real time
Email support: unlimited
Validation
Mobile assistence
Express delivery
VIDEO ANALYSIS OF THE REPORT
Most requested
Evaluation
3 analytes in 1 formulations
€ 7750
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Line
6 analytes in 2 formulations
€ 11650
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Express
7
Working
Days
1 analyte in 1 formulation
€ 8199
Updates: in real time
Email support: unlimited
Validation: according ICH
Mobile consultancy: 30 minutes
VIDEO ANALYSIS OF THE REPORT
Express delivery
Most requested
Take the quiz below and find out now what is the best permeation package for you
What is your primary goal for this permeation study?
If you are developing a new formula and want to test the efficacy of the portotypes, or
if you want to increase customer product confidence with scienbtific data,
you can save time and money with a standrd protocol.
Formulating a new product
Optimizing the formula based on permeation studies.
Writing a technical file
Proving the permeation promotion or barrier effect for product authorization.
Building the product trust
Communicating the product's efficacy with laboratory data.
How many analytes do you need to test?
If you have a tentative number of analytes to test, move the sliders to the corresponding range.
If you know the exact number of analytes, overlap both sliders to the corresponding number.
How many formulations do you need to test?
If you have a tentative number of formulations to test, move the sliders to the corresponding range.
If you know the exact number of formulations, overlap both sliders to the corresponding number.
Receive 10% discount
Fill out the form to find out what the best permeation package is for you,
receive the results in your inbox,
along with a 10% discount on your next study.
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Supplements
Food and Foodstuffs
Medical Devices
Pharmaceuticals
Cosmetics
With Technology Scientific in vitro permeation studies,
your products will reach your
customers faster
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