BRG recognizes that innovative technologies not often than not have the potential to raise a spectrum of scientific and technical development issues.
Drugs and development
Well, now, Combination products are increasingly incorporating cutting edge technologies, which are novel and hold great promise for advanced patient care. Innovative combinations of drugs, biologics, and devices have the potential to make treatments much safer, more effective, more convenient, or acceptable to patients which leads to Combination drug development.
For example, drug-eluting cardiovascular stents may be highly useful in reducing the need for repeated surgery by helping to prevent the restenosis that might occur after stent implantation.
Medicines and biologics are often utilized in combination to potentially improve the security and/or effectiveness of either product used alone. Proteins incorporated into novel orthopedic implants can facilitate the regeneration of bone necessary to permanently stabilize the implants. Drug device inhalation systems provide a new route of insulin delivery that can reduce the need for insulin injections. As with other medical products, combination development typically focuses on the scientific and technical issues raised by the actual product being developed. Due to which combination of drug product development is taking place. In the case of a combined product, these scientific-technical questions will normally reflect the combined product itself, as well as its constituent parts. When combining products such as drugs or biologics and devices that are commonly developed using different regulatory paradigms, critical developmental issues, such as drug / biologic interaction and device components, may not be apparent. Furthermore, due to the breadth, innovation, and complexity of bundled products, there is no single development paradigm appropriate for all bundled products.
Also Read: Post-marketing surveillance of drugs
Manufacturing, scale-up, and quality management are quite vital considerations during the overall development of a combination drug product. Manufacturing methodologies have this tendency to affect both premarket development and post market regulation. For example, the stability or reliability of a combined product as a whole may be different from that of the independent constituent parts. Certain constituent parts of drugs or biological products can be altered or destroyed by end-sterilization techniques. For constituent parts using aseptic manufacturing techniques, developers are encouraged to implement manufacturing techniques to make sure aseptic control of the combined product.
Biotech Research Group
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