Intelligent co-design of material, process, and equipment for manufacturing high-quality traditional Chinese medicine preparations / 中国中药杂志

In the context of Pharma 4.0, the design tools that support the pharmaceutical Quality by Design(QbD) are iterating fast toward intelligent or smart design. The conventional development methods for traditional Chinese medicine(TCM) preparations have the limitations such as over dependence on experience, low dimensions for the designed experiment parameters, poor compatibility between the process and equipment, and high trial-and-error cost during process scale-up. Therefore, this paper innovatively proposed the intelligent co-design involving material, process, and equipment for manufacturing high-quality TCM preparations, and introduced the design philosophy, targets, tools, and applications with TCM oral solid dosage(OSD) as an example. In terms of design philosophy, the pharmaceutical design tetrahedron composed of critical material attributes, critical process parameters, critical equipment attributes, and critical quality attributes was developed. The design targets were put forward based on the product performance classification system. The design tools involve a design platform that contains several modules, such a as the iTCM material database, the processing route classification system, the system modeling and simulation, and reliability-based optimization. The roles of different modules in obtaining essential and universal design knowledge of the key common manufacturing units were introduced. At last, the applications of the co-design methodology involving material, process, and equipment in the high shear wet granulation process development and the improvement of the dissolving or dispersion capability of TCM formula granules are illustrated. The research on advanced pharmaceutical design theory and methodology will help enhance the efficiency and reliability of drug development, improve the product quality, and promote the innovation of high-end TCM products across the industry.

Why Darwin rejected intelligent design.

Natural Theology is constructed around the analogy of a watchmaker, a metaphor borrowed from previous advocates of the design doctrine. Imagine, Paley suggests, that you are walking across a heath and suddenly encounter a watch lying on the ground. After close inspection of the watch, you would be compelled to conclude that such an intricate device could not have been constructed otherwise in order for it to work. It is only reasonable to assume “that the watch must have had a maker; that there must have existed, at some time and at some place or other, an artifi cer or artifi cers who formed it for the purpose which we fi nd it actually to answer; who comprehended its construction, and designed its use” (1802:3–4). In the case of living organisms Paley continued, the evidence for design is even stronger “in a degree which exceeds all computation” (1802:19), and he concluded: “The marks of design are too strong to be got over. Design must have had a designer. That designer must have been a person. That person is GOD” (1802:473). The efforts by Ray, Paley, and others to unite natural history with theology were among the inducements that inclined Darwin, at the age of eighteen, to look favourably on a career in the church. Sent by his father two years earlier to study medicine at Edinburgh University, Darwin had found himself uninspired by this profession and revolted by the sight of operations, which at that time were conducted without the benefi t of anesthesia. Worried that his son might turn into “an idle sporting man,” Darwin’s.

Some considerations about the theory of intelligent design

The so-called theory of intelligent design (ID) has gained a growing reputation in the Anglo-Saxon culture, becoming a subject of public debate. The approaches that constitute the core of this proposal, however, have been poorly characterized and systematized. The three most significant authors of ID are certainly Michael Behe, William Dembski and Stephen Meyer. Beyond the differences that can be distinguished in the work of each of them, the central fact in their arguments is the complexity of living organisms, which according to these authors, escapes any kind of natural explanation. In effect, according to the authors of ID, the irreducible complexity that can be detected in the natural world would allow to infer design in a scientifically valid way, even though many of them prefer to remain silent regarding the identity and attributes of the designer. We think that under this proposal, remains a deep epistemological confusion, since its very structure combines methodologies that are beyond the scope of historical and natural evolutionary theories. We also reject the claim that ID is a legitimate scientific theory, because it does not exhibit the classical characteristics that a scientific kind of knowledge must have.

The threat from creationism to the rational teaching of biology

Most biologists outside the USA and a few other countries, like Australia and Canada, are under the impression that the threat to the teaching of biology represented by creationism does not concern them directly. This is unfortunately no longer true: the recent growth of creationism, especially in its pseudo-scientific manifestation known as "intelligent design", has been obvious in several countries of Western Europe, especially the UK, Germany and Poland, and it is beginning to be noticeable in Brazil, and maybe elsewhere in Latin America. The problem is complicated by the fact that there are not just two possibilities, evolution and creationism, because creationism comes in various incompatible varieties. Turkey is now a major source of creationist propaganda outside the USA, and is especially significant in relation to its influence on Muslim populations in Europe. The time for biologists to address the creationist threat is now.