Regulatory differences

Process inputs Crude feed stocks with variable properties Pure, high-quality raw materials 

Sample type Homogeneous or slurry Heterogeneous, often blends of solids 

Control Approaching control limit that On target at the center of the 

Product specifications Broad range of products tailored for distinct applications (potentially very tight tolerances) Narrow range of product specifications 

Of the many regulatory aspects that influence the extent of the use of PAT in the pharmaceutical industry in comparison to the chemical industry, two items with particular significance should be discussed in detail in this section the concept of process validation and the need to comply with cGMPs in development manufacturing. 

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QUATTROCCHIO, F, WING, J.F., VAN DER WOUDE, K., MOL, J.N.M., KOES, R., Analysis of bHLH and MYB domain proteins Species-specific regulatory differences are caused by divergent evolution of target anthocyanin genes, Plant J., 1998,13,475-488. 

Figure 6.16 Model illustrating interspecific regulatory differences in an early-stage reaction in isoprenoid pheromone biosynthesis between male Ips paraconfusus Lanier and Ips pini (Say). Feeding on host phloem results in synthesis of the full amount of the major pheromone component and full activity of HMG-R for both species. The impact of feeding on HMG-R transcript levels is yet to be determined. Topical treatment of male I. pini with JH III mimics feeding nearly completely in terms of pheromone mass and HMG-R activity. Topical treatment of male I. paraconfusus with JH III does not mimic feeding in terms of pheromone mass or HMG-R activity. Topical treatment of both species with JH III results in significantly enhanced levels of HMG-R transcript. One hypothetical explanation for the interspecific difference is that a second hormone (SH) or factor may be associated with the synthesis, stability, and/or activity of HMG-R in I. paraconfusus.

D C and external D C colorants may be used to color drugs and cosmetics with certain restrictions. A basic regulatory difference between FD C, D C, and external D C colorants is that D C and external D C colorants have specific uses and resfricfions. The classifications of D C and external D C mean little today, because many of the colorants listed as D C are restricted to external uses. 

When comparing the United Kingdom, the United States and Norway, it appears that there are regulatory differences between the three countries. In addition, there are differences in the legal requirements and traditions of cooperation with respect to reporting and transparency. Hence, access and quality of information needed for developing indicators varies. 

The definition of foods, dietary supplements, and drugs and their respective safety standards are essential to the understanding of the regulatory differences between these classes of bioactive materials. It is beyond the scope of this chapter to delve into the rationale behind the regulations, but the concept of intended use is a critical differentiator between foods, dietary supplements, and drugs, which are defined in the following manner ... 

Drug and medical device regulatory differences and similarities... 

Comments This question requires that a student think about and then explain the differences in rapid and slow oxidation and relate them to properties of toxicity, flammability, and explosiveness of gasoline. It would even be possible to turn this into a multiple-answer machine scorable linked question by listing the possible true or false statements the student might make and asking the students to choose which statements support the regulatory difference. 

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