Scientifically valid definition
What is "scientifically valid"? - Eurofins USA
Scientifically Valid Method vs. Validated Method – What is the difference?By Jeff Stassi - Eurofins Senior Analytical Service Manager - Dietary Supplements
The dietary supplement industry has become an increasingly regulated industry since the introduction of the dietary supplement GMPs in 2007. There has also been a distinct focus on the analytical testing procedures over the years with a number of citations that have focused on analytical testing and the validity of the test methods being used.
To this day, there still is industry confusion as to the requirements needed to comply with the dietary supplement GMP requirement to use a scientifically valid method.
Does this mean the method must be validated?
What needs to be understood is that the FDA did not define the term “scientifically valid method” in the 800-page final rule. That left the industry wondering how they would comply with the requirement if there was no established definition for the term.
What we have learned over the years for dietary supplements is that the accepted criteria for a scientifically valid method is that it must be the following:
- precise
- accurate
- specific for its intended use
- consistently does what it is intended to do
In other words, there is an aspect of validation that falls within these terms. A supplement company should, however, define what criteria is necessary within their organization to consider it a scientifically valid method. In the pharmaceutical industry, many more parameters that must be followed take it to a completely new level. Therefore, you can certainly have a scientifically valid method without having a fully validated method. Thankfully, with the complexity of the formulations in supplements, not all of these validation parameters are required.
Here are the differences that will separate the requirements of a scientifically valid method and a fully validated method.
Accuracy
Precision / Repeatability
Intermediate precision / Reproducibility
Robustness / Ruggedness
Specificity
Linearity
Range
Detection Limit / Quantification limit
Degradation / forced degradation
Standard and Solution stability
SCIENTIFICALLY VALID METHODAccuracy
Precision / Repeatability
Intermediate precision / Reproducibility
Specificity
At Eurofins, we understand that trying to decipher what is required for your products can be a difficult task. We have experts available that will help you talk through your testing plans and discuss the methods with you so that you can determine if they meet your company's criteria for being "scientifically valid".
Contact us with your questions today!
Want to read more about this topic?
Here is an article authored by Jeff Stassi from the "Natural Products Insider" originally published on August 15, 2013.
Source: https://www.naturalproductsinsider.com/manufacturing/scientifically-valid-lab-testing-major-focus-fda
Scientifically Valid: Lab Testing a Major Focus for FDA
The dietary supplement industry has become an increasingly regulated industry since the 2007 introduction of cGMPs (current good manufacturing practices) for dietary supplements. This has forced many companies to dramatically increase their testing programs as well as their scientific understanding of the development of their products. One requirement that continues to elicit questions and be a source of ambiguity is the term scientifically valid." In fact, the exact requirement in FDA 21CFR Part 111, which is specific to manufacturing, packaging, labeling or holding operations for dietary supplement, states, You must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods."
When new guidance or new terminology is introduced to industry, uncertainty often follows.
It is also challenging for companies to achieve compliance when uncertainty and lack of specific direction leads to inconsistencies in how companies implement the same requirement.
The lack of definition for the term scientifically valid" has been of major discussion among dietary supplement companies, trade organizations, regulators, laboratories and industry insiders. One thing is certain, in addition to the FDA's focus on the manufacturing practices of dietary supplement companies, the agency is also emphasizing the analytical approach used to support the quality of manufactured products, from raw materials to finished products. Currently, a higher percentage of audit findings are related to laboratory operations compared to this time last year. Many of these findings indicated a deficiency in the testing, lack of sufficient and scientifically valid methods, improper identity tests, and lack of test data to support the quality of their products. Companies are being called out on these deficiencies and are looking for more analytical support.
Recently, an FDA warning letter was issued to a company because an inspector pulled a product for testing of a biotin supplement, which subsequently showed the level of biotin to be approximately 5 percent what was claimed on the label. This illustrates FDAs movement toward auditing companies and, as part of that process, testing products for compliance to label claims and nutrient content. Manufacturers must be more prepared than ever to test raw materials and finished products to ensure specifications are met and that the stated amount of each dietary ingredient is present at the level declared.
FDA places the burden of proof on the manufacturer, whether or not it tests its products in-house or with a third-party laboratory. Continue Reading...
Validity and Reliability - How to Know if the Research is Correct?
The principles of validity and reliability are fundamental cornerstones of the scientific method.
Discover 21 more articles on this topic
Don't miss these related articles:
- Types of Validity
- Definition of Reliability
- Content Validity
- Construct Validity
- External Validity
Together, they are at the core of what is accepted as scientific proof, by scientist and philosopher alike.
By following a few basic principles, any experimental design will stand up to rigorous questioning and skepticism.
What is Reliability?
The idea behind reliability is that any significant results must be more than a one-off finding and be inherently repeatable.
Other researchers must be able to perform exactly the same experiment, under the same conditions and generate the same results. This will reinforce the findings and ensure that the wider scientific community will accept the hypothesis.
Without this replication of statistically significant results, the experiment and research have not fulfilled all of the requirements of testability.
This prerequisite is essential to a hypothesis establishing itself as an accepted scientific truth.
For example, if you are performing a time critical experiment, you will be using some type of stopwatch. Generally, it is reasonable to assume that the instruments are reliable and will keep true and accurate time.
However, diligent scientists take measurements many times, to minimize the chances of malfunction and maintain validity and reliability.
At the other extreme, any experiment that uses human judgment is always going to come under question.
For example, if observers rate certain aspects, like in Bandura’s Bobo Doll Experiment, then the reliability of the test is compromised. Human judgment can vary wildly between observers, and the same individual may rate things differently depending upon time of day and current mood.
This means that such experiments are more difficult to repeat and are inherently less reliable. Reliability is a necessary ingredient for determining the overall validity of a scientific experiment and enhancing the strength of the results.
Debate between social and pure scientists, concerning reliability, is robust and ongoing.
What is Validity?
Validity encompasses the entire experimental concept and establishes whether the results obtained meet all of the requirements of the scientific research method.
For example, there must have been randomization of the sample groups and appropriate care and diligence shown in the allocation of controls.
Internal validity dictates how an experimental design is structured and encompasses all of the steps of the scientific research method.
Even if your results are great, sloppy and inconsistent design will compromise your integrity in the eyes of the scientific community. Internal validity and reliability are at the core of any experimental design.
External validity is the process of examining the results and questioning whether there are any other possible causal relationships.
Control groups and randomization will lessen external validity problems but no method can be completely successful. This is why the statistical proofs of a hypothesis called significant, not absolute truth.
Any scientific research design only puts forward a possible cause for the studied effect.
There is always the chance that another unknown factor contributed to the results and findings.
This extraneous causal relationship may become more apparent, as techniques are refined and honed.
Conclusion
If you have constructed your experiment to contain validity and reliability then the scientific community is more likely to accept your findings.
Eliminating other potential causal relationships, by using controls and duplicate samples, is the best way to ensure that your results stand up to rigorous questioning.
Site map
| home Education Library Site map
|
2.014.01 From proposition, substantiation to hypotheses
When writing any scientific work, the researcher faces the task of setting a hypothesis.
This is the starting point that determines the content and results that will be obtained in the course of the study.
Content:
A hypothesis is the basis of any scientific theory, it allows a scientist to start searching, collect and analyze facts in order to reasonably confirm or refute the put forward assumption. That is why the hypothesis is given such close attention.
Hypothesis (translated from Latin hypothesis) is an assumption or conjecture that cannot be proved using the current level of science. Analysis of the problem allows you to get answers to the questions “Is the assumption made correct? Why is it true? How is this justified, by what facts and arguments? The task of the researcher is to find an argument that allows one to consider the thesis to be true or to refute it.
Assistance in the publication of scientific articles. SibAK publishing house provides full support of the article and transparency of the publication process at all stages.
This is one of the most common methods of scientific and other cognitive activity, which makes it possible to find a logical explanation of the nature of the origin of any phenomena. There are general (for a group of phenomena) and particular (for specific events) hypotheses, as well as predictive and explanatory ones.
In order to correctly formulate the hypothesis of any research, it is necessary to follow the principles of the logical construction of scientific knowledge:
- Consistency of the put forward hypothesis. Making certain assumptions or conjectures, the scientist must uncover the subject area of research as fully as possible.
- Applicability of the created knowledge. All hypotheses are built not to explain individual, specific cases, but to be able to explain a wider range of natural, social or theoretical phenomena.
- Verification. To put forward a hypothesis, it is important to understand and master the tools for its verification.
Requirements for the hypothesis:
- compatibility with existing knowledge, fundamental scientific principles, previously established facts;
- clarity and consistency, no ambiguity;
- validity (relevance), that is, the consistency of the theory put forward, verified by analysis;
- it must be verifiable (observation, measuring instruments, experimental setups and other reliable means available).
The standard structure of a hypothesis consists of two parts: an empirical foundation (premise) and an assumption based on it (conclusion). Her nomination is the result of extensive work, which includes the study of theoretical foundations, the collection of material, its analysis, experiments and observations. Basic preparation steps:
- accumulation of material, assumptions, conjectures about the investigated object or phenomenon;
- formulating the consequences arising from the hypothetical theory, putting forward preliminary answers and solutions to the problem;
- refutation of assumptions that turned out to be untenable, their replacement with reliable ones that correspond to the actual data received;
- verification of the conclusions drawn in practice.
Justification methods
Substantiation of the truth of new scientific knowledge largely depends on its specificity, profile orientation, and practical relevance. But for any hypotheses, it is necessary to carry out three general types of justification: theoretical, logical and empirical.
Theoretical substantiation of - verification of its compliance with the key principles of the scientific and subject area. New knowledge must be verifiable, relevant to the categorical apparatus, correspond to the basic tasks of a particular area of scientific knowledge.
Rationale – compliance with the norms of formal-logical thinking. It is necessary to observe the principle of consistency, to apply the methods of inductive and deductive knowledge for justification.
Empirical justification - practical, experimental, laboratory verification. For different types of scientific knowledge, specific methods of experiment are assumed.
To confirm (or, conversely, refute) a hypothesis, it is necessary to follow the rules of logic. So, the conclusion (thesis or antithesis) must be precise and clear, unchanged in the process of research. As grounds (arguments), only true facts that have already been established earlier are accepted.
The reasoning must be sufficient to formulate a final conclusion. If the test shows that the hypothetical statement made by the scientist is true, the hypothesis receives the status of a scientific theory that requires further study.
The refutation of the hypothesis, justified by the falsity of its conclusion, is not ruled out. In this case, they go the way of falsification, establishing a discrepancy between the facts arising from the assumption and the consequences, or by proving the antithesis (the opposite of the hypothesis of the consequence).
If the antithesis is proven, logically this means the inconsistency (falsity) of the original thesis.
Building and testing
Having completed the formulation of the hypothesis and its justification, it is necessary to proceed to the final stage - verification. Here it is necessary to apply the falsification method formulated by the classics of the philosophy of science. According to him, new knowledge is valuable only if there is an opportunity and a way to refute the hypothesis.
Such verification of the truth of the hypothesis is carried out according to the same principles as the justification. Be sure to use empirical verification, theoretical verification, logical proof. But at the same time, a number of alternative provisions and statements are put forward.
This check performs a double task. First, the truth of the formulated hypothesis and the possibility of its application in scientific or technological terms are confirmed.
Secondly, the foundation is being prepared for the development of scientific knowledge, the advancement of new hypothetical conclusions. This ensures the continuity of the development of science.
Methods of scientific knowledge
English philosopher F. Bacon and logician, economist J. Mill proposed 4 methods of hypothesizing based on the establishment of cause-and-effect relationships.
- The similarity method consists in the assumption that if several cases of an observed phenomenon have a similar circumstance, then it is precisely this circumstance that is the cause of the object under study. The technique involves the establishment of all possible cases and circumstances, a deep analysis of the differences, the definition of probability.
- The difference method is the opposite of the previous one. That is, if in one case the circumstance occurs, but not in the other, then, most likely, the reason lies in the investigated condition for the onset of consequences.
Note: from the first two methods an additional one is formed - similarities and differences.
- The method of concomitant changes - establishing the relationship of various phenomena.
- Method of residuals or exclusion (that is, if it is known that the cause is definitely not one of the conditions, then it is assumed that it is caused by the circumstance under investigation). This technique was actively used in his scientific activity by A.S. Popov conducting radio experiments in 1897 year. So, he drew attention to the fact that other ships passing between the ships disrupt the radio traffic. He came to the conclusion that the cause of the interference is the metal hull of the ship, which shields electromagnetic waves.
The methods discussed above are most often used to substantiate hypotheses in the aggregate, harmoniously complementing each other. Even experienced scientists face the problem of well-founded hypotheses.
