How can you use independent methods to validate biomaterials characterization results?

1 Why validate?

Validation is the process of confirming that a method or a result is correct, consistent, and reproducible. Validation is essential for biomaterials characterization because it can improve the quality, reliability, and credibility of the data and the conclusions. Validation can also help identify and correct potential sources of error, such as instrument calibration, sample preparation, environmental conditions, or human factors. Validation can also help compare and correlate different methods and results and establish standards and protocols for biomaterials characterization.

3 What are orthogonal methods?

Orthogonal methods are methods that measure different aspects or dimensions of the same property or parameter of a biomaterial. For example, if you want to measure the molecular weight of a polymer biomaterial, you can use orthogonal methods such as gel permeation chromatography (GPC), which measures the size distribution of the polymer chains, and nuclear magnetic resonance (NMR), which measures the number of monomer units in the polymer chains. Orthogonal methods can provide more comprehensive and accurate information about a property or parameter of a biomaterial and help validate the results obtained by each method.

4 What are alternative methods?

Alternative methods are methods that measure the same aspect or dimension of the same property or parameter of a biomaterial using different techniques or instruments. For example, if you want to measure the surface roughness of a metal biomaterial, you can use alternative methods such as atomic force microscopy (AFM), which measures the height variations of the surface using a probe, and optical profilometry (OP), which measures the light reflection of the surface using a laser. Alternative methods can provide more consistent and reliable information about a property or parameter of a biomaterial and help validate the results obtained by each method.

5 How to choose independent methods?

When selecting independent methods to validate biomaterials characterization results, several factors should be taken into consideration, such as the type and purpose of the characterization, the availability and cost of the methods, and the quality and quantity of data. Generally, it is recommended to choose methods that are relevant, appropriate, and suitable for the property or parameter of interest and the type and form of the biomaterial. Additionally, it is important to pick methods that have different sources of error, uncertainty, or variability and can compensate for each other's limitations. Furthermore, methods with similar or comparable ranges, resolutions, sensitivities, and accuracies should be chosen in order to produce consistent results. Moreover, different levels of complexity, sophistication, and automation should be considered in order to provide different levels of detail. Lastly, methods with different requirements, constraints, and conditions should be selected in order to adapt to different situations and samples.

6 How to use independent methods?

Using independent methods to validate biomaterials characterization results involves several steps, such as planning, performing, analyzing, and reporting. To do this effectively, you must plan the validation strategy and select the independent methods based on the factors mentioned above and the specific objectives and criteria of the characterization. Once you have chosen the methods, you should perform the characterization following standard operating procedures and quality control measures for each method. Additionally, data analysis should be done using appropriate statistical tools and methods. Finally, it is important to report the validation results and the validation methods used, highlighting the similarities, differences, advantages, and disadvantages of the independent methods and the implications and limitations of the validation for the biomaterials characterization.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?