Because the specifications for posttranslational modifications and other quality attributes of a biosimilar will likely vary from those of the reference product, owing to the complexity of biologics and their manufacturing processes, biosimilars should not be considered to have the "same" active substance as their reference product or other biosimilars of the same reference product.
The authors argue that this approach allows the formalization of architectures in different abstraction levels, which facilitates architectural maintenance and evolution because the specification is modular and hierarchical.
Additional analysis can lead to a more precise reading of the data because the data specification and data distribution across the groups are generated automatically.
Charles E. Dell Mitchellville, Md., Aug. 19, 2007 To the Editor: America's highway bridges are the safest in the world because the specifications under which they are designed, inspected and built are the strictest, most up to date in the worldwide bridge design community.
Because the specifications capture phase information, the level of over-design in certain MIMO QFT designs is reduced.
Because the specification provides a way to produce a self-describing file, it would be a simple matter to port the data from TMA files into virtually any commercial or open source database.
Moreover, this new feature is better to handle the architectural evolution because it allows the specifications to be managed and distributed by software configuration tools in a similar way as it is done with source code.
These results are critical for implementation of particulate-filled polymer composites in practical applications because relaxed material specifications and handling procedures can be incorporated in production environments to improve efficiency.
This is an important aspect because it allows the specification of independent and flexible models.
At a first time, SADT (Structured Analysis and Design Technique) method was proposed to organize the specifications because it is a functional analysis method [IGL, 89] and commonly used in railway sectors.
