What are the challenges and potential solutions for ensuring consistency in determining prior art and novelty of natural products?
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Ensuring consistency in determining prior art and novelty of natural products presents challenges due to their complex compositions and batch-to-batch variations . Quality control methods like DNA molecular markers have revolutionized authentication processes, aiding in identifying adulterants and authenticating medicinal plants . However, the poor quality of some herbal products, stemming from misidentification, substitution, adulteration, or contamination, poses safety concerns and affects efficacy . To address these issues, a totality-of-evidence approach by the US FDA integrates analytical testing with raw material control, bioassays, and clinical data to ensure product quality consistency and therapeutic effectiveness . Implementing genome-based methods and rigorous quality control measures can enhance the reliability and authenticity of natural products, thereby overcoming challenges in determining their prior art and novelty.
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| Papers (5) | Insight |
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01 Jan 2019 4 Citations | Challenges in ensuring consistency of natural products include batch variations. The FDA's totality-of-evidence approach integrates raw material control, bioassays, and clinical data to address these challenges effectively. |
| Challenges in ensuring consistency of herbal products include misidentification, adulteration, and contamination. Chemical evaluation techniques can enhance quality control and assurance for improved product consistency. | |
12 Feb 2018 | Challenges include maintaining herbal product quality and authenticity. Molecular markers like PCR aid in identifying adulterants and ensuring consistency in natural product authentication. |
| Challenges in determining prior art and novelty of natural products include chemical diversity. Solutions involve advanced analytical techniques like UHPLC/Q-TOF-MS for precise compound localization and identification. | |
| Challenges in patenting natural products include their origin from nature, making them non-patentable. Solutions involve demonstrating novelty and non-obviousness through unique characteristics and applications. |
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