ServiceS
Why do I need to consider botanical drug IND?
Dietary supplements:
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Cannot make medical claims: dietary supplements are restricted from making medical claims, limiting their market positioning.
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Low market barrier and high competition
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High product development cost leading to low-profit margin
What a botanical drug IND provides:
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A botanical drug IND allows you to make distinct medical claims, creating a market barrier
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Botanical drugs are not required to show specific active ingredients.
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Botanical drugs can be developed from a single plant or a blend of multiple plants, providing flexibility in product development.
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No need to describe the mechanism of action
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The success rate is significantly higher when developing known safe and effective botanical products compared to synthesizing or purifying new chemical molecules.
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The concept of botanical drugs primarily exists within the FDA regulatory framework and is specific to the process of regulatory filing and approval. Once botanical products receive approval as prescription drugs and enter the market, there is no perceived difference from chemical drugs.
What is the difference between isolating active ingredients vs botanical drug approach?
Isolating active ingredients approach follows the small molecule IND route, necessitating the description of the mechanism of action, identifying active ingredients responsible for medical benefits, and describing the mechanism of action. All those requirements are resource-intensive and time-consuming. In addition, uncertainty exists regarding whether an isolated active ingredient will produce the same medical benefits as the whole botanical product
Botanical drug approach:
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In the FDA botanical drug development category, there's no requirement for the purification or isolation of active ingredients.
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A botanical drug product can consist of a single plant, a portion of a single plant, or a mixture of multiple plants.
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No mechanism of action description is necessary.
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If a final drug product demonstrates safety and efficacy through FDA IND Phase 1, 2, and 3 trials, it can gain approval as a prescription drug in the US market. The FDA assesses the safety and efficacy of the entire drug product, not individual ingredients.
Conclusion:
The botanical drug IND development pathway offers an efficient route for drug development, particularly when compared to the conventional approach of isolating active ingredients.
What data is required to open an IND with the FDA?
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Product name, description of plant products, a short description of the manufacturing process, and the final product formulation
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Historical background information on the product development
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in vitro pharmacology, in vivo pharmacology, in vivo toxicology, pharmacokinetics
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HPLC full spectrum fingerprints of the final drug product
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Product scale-up and final formulation
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Animal and clinical studies plans
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Proposed indication or context of product development
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Summary of studies completed
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Prior human experience, if any
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Proposed clinical study plan, whether the animal efficacy rule is being considered
Preclinical Studies
In contrast to the IND process for a single molecule, the preclinical development of drug products consisting of a mixture of plants is notably more intricate. While the specific ingredients and indications may vary among different IND applications, all preclinical studies for botanical drugs follow a common formula for success:
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Qualification and quantification of ingredients in a botanical drug product
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Establishment of quality control mechanism for a botanical drug product
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Identification of unknown ingredients in a botanical drug product
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Quantification of known ingredients in a botanical drug product
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In-vitro study for a botanical drug product with multiple ingredients
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In-vivo study for a botanical drug product with multiple ingredients
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Pre-clinical pharmacokinetics study for a botanical drug product with multiple ingredients
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Dose-response study for a botanical drug product with multiple ingredients
FDA Botanical Drug pre-IND Briefing Package Development
ABDA expert team follows a structured process to support the development of your botanical drugs:
1. Review of Raw Materials: We conduct a thorough assessment of the raw materials involved in your botanical drug product. This step ensures that all components are in compliance with FDA regulations and guidelines.
2. Content Collection: Our experts gather and compile all the necessary content required for the pre-Investigational New Drug (pre-IND) packet. This includes data on ingredients, quality control, safety, efficacy, and other essential information.
3. Pre-IND Packet Development: ABDA's team uses the collected data to create a comprehensive pre-IND packet that aligns with FDA requirements. This packet serves as a foundational document for your botanical drug development process.
4. Submission to FDA: We facilitate the submission of the pre-IND packet to the FDA on your behalf. This step ensures that all required documentation is properly presented to the regulatory agency.
5. FDA Meeting Coordination: ABDA assists in arranging meetings with the FDA for discussions related to your botanical drug development. These meetings provide an opportunity to address any questions or concerns and seek clarification on FDA expectations.
6. Interpretation of FDA Decision: Upon receiving feedback from the FDA, our experts interpret the FDA decision letter, helping you understand the agency's feedback and recommendations. This interpretation is crucial for making informed decisions on the next steps in your drug development process.
ABDA's expertise in navigating the FDA Botanical Drug Development process streamlines the development of botanical drugs, ensuring compliance with FDA guidelines and enhancing the likelihood of successful regulatory approval.