Botanical Products and the Biotechnology Industry
According to the some States Pharmacopoeia, botanical products that are regulated as medications include: plants, mixtures, essential oils, essential gums, essential oils with the purpose of remedying, treating, preventing, or curing a disease. Products are only considered drugs if they contain the designated ingredients or if they are manufactured by means of plants in a controlled environment. Examples of botanical products which may have been determined as drugs by the United States Pharmacopoeia include: cholesterol lowering medications, antihistamines, anti-seizure medications, drugs for AIDS or related disorders, certain antibiotics and antiviral drugs.
In order to determine whether the botanical product meets the criteria for FDA approval as a drug or not, there are several requirements which must be met. These requirements generally have been established by scientific studies in the field. For example, it is required that a drug should have been tested by published and peer reviewed scientific studies. The published studies must demonstrate efficacy and safety. They also need to be consistent with published guidelines for design, dosage, administration, and contraindications. Visit this store for more info on Botanical drug products.
The Botanical drug product has to demonstrate the ability to treat, prevent, cure, or alleviate a disease or condition. It also needs to be well tolerated by patients and should not produce any undesirable side effects. Finally, it must be safe for use as directed. The Botanical drug product NDA is the first step in obtaining approval as a botanical drug from the United States Pharmacopoeia and several other countries. If you want to manufacture and distribute botanical drug products in the United States, you will need to file an NDA.
In addition to filing an NDA, pharmaceutical companies are required to perform additional tests on their botanical drug products and clinical trials before they can commence marketing them. The company's primary concern, of course, is to obtain approval from the United States Food and Drug Administration or FDA. To this end, they contract services from qualified laboratories that test and monitor the botanical drug products and their manufacturing process until the applications are approved for market entry. At this point, a company usually seeks the assistance of outside commercialization companies and/or healthcare providers to aid in the submission of the application to the FDA. View more details on Botanical drug product in this article.
Outside commercial entities usually contract with qualified staff in universities, colleges and hospitals to conduct the necessary clinical trials and to monitor the manufacturing facilities during the manufacture and packaging processes. The pharmaceutical and bioengineational industries utilize these services to support the accelerated development of botanical drugs and their production processes. Likewise, academic and industry partners frequently utilize outside services in the development of new pharmaceutical formulations. The goal is to reduce the cost of development in the laboratory, while ensuring that the medicines reach the market on schedule and within budget.
Botanical Products have the potential to meet the needs of the pharmaceutical and bioengineational industry in numerous ways. These products have the ability to address the deficiencies in the manufacturing of therapeutic proteins, such as collagen, which can lead to the degradation of human health. They also can increase the efficiency with which target molecules are released into the body and throughout the system. Botanical products can be used to replace many of the expensive human-based ingredients that are presently used in the production of botanicals, increasing the affordability of the medications and facilitating the development of stronger botanicals for use in human health. Check out this post for more details related to this article: https://en.wikipedia.org/wiki/Botanical_drug.
