Bioequivalence studies are very important for the development of a pharmaceutical preparation (drugs/medicine) in the pharmaceutical industry. Bioequivalence study refers to drug substances in two or more dosage forms. This is conducted if there is a risk of failure. Let us discuss how the bioequivalence study is implemented.
Whenever a new product is intended or found to be a substitute of an approved medical product as a pharmaceutical equivalent or alternative by the pharmaceutical team, the equivalence of this product should be known or justified .in order to ensure this, bioequivalence study. When statically significant changes are observed in bioavailability in two or more drug products bioequivalence is identified. This requires a longer time to complete the studies.
Types of Bioequivalence studies:
The whole process of Bioequivalence studies is implemented in two ways as there are two types of Bioequivalence studies. They are:
- Vivo Bioequivalence study
- Vitro Bioequivalence study
Bioequivalence is determined based on bioavailability. Bioavailability of the newly invented medicine versus generic medicine – For example, there are two medicines to be determined as bioequivalent there must be no more than a 20% difference between the AUC and Cmax. If two products are said to be bioequivalent then it means that they are to be expected to be the same. Bioequivalence study usually takes a longer period of time but bioequivalence study minimizes the carry-over effect.
Contract manufacturing organization (CMO):
Contract manufacturing organization is a Production of goods by one firm, under the label or brand of another firm. Contract manufacturer organization provides such service to several (even competing) firms. Based on their own or the customers’ designs, formulas, and/or specifications they provide suitable firm also called private label manufacturing. For example, large companies that manufacture computer hardware use contract manufacturing organizations for the smaller computer parts and components, which in turn is manufactured by other firms. Let us discuss the importance and advantages of a contract manufacturing organization.
Importance of contract manufacturing:
The idea of contract manufacturing is to enable the client to get one unimportant task off their hands. The client can also save a lot of money in the process. The contractors have the necessary infrastructure and manpower to begin the production process which the client has requested .they help the client expand and meet the global demand.
A contract manufacturing organization is also known as a contract development and manufacturing organization. Contract manufacturing organization is a company that serves other companies in the pharmaceutical industry on a contract basis. They provide comprehensive services from drug development through drug manufacturing. A contract manufacturing company may offer significant cost advantages over an organization’s internal production facilities rather than investing expensive capital in production equipment and hiring skilled labor in regions where some business necessities are expensive.
Many things play into reducing costs:
- skilled labor
- bulk purchasing
- reduced errors
Contract manufacturing is used because companies can save on labor, materials, and other expenses of production as mentioned above. Taken these advantages into consideration client prefer these contract manufacturing organization to get their work done with less expensive.