Regulation process-based

The regulation process based on LeChatelier s principle is similar to the acetic acid-sodium acetate buffer, which we have already discussed. 

The appHcabiHty of many of the government regulations are based on the Standard Industrial Classification (SIC) of the process and/or faciHty. 

Air toxics regulations apply to several parts of the pulp and paper milling process. National Emission Standards for Hazardous Air Pollutants (NESHAP) have been developed expressly for two processes of the pulp and paper industry. These standards establish process-based maximum achievable control technologies (MACT) for major sources, which are defined as facilities that emit or have the potential to emit 10 t per year or more of any hazardous air pollutant (HAP) or 25 t per year or more of any combination of HAPs. 

Excess nitrogen is eliminated from the body in the urine. The kidney adds small quantities of ammonium ion to the urine in part to regulate acid-base balance, but nitrogen is also eliminated in this process. Most excess nitrogen is converted to urea in the liver and goes through the blood to the kidney, where it is eliminated in urine. 

For any speciation process based on pheromonal communication to be effective, variation in CHC production should tightly co-evolve with factors regulating CHC processing. This has been observed for the desatl gene in D. melanogaster (Marcillac et al., 2005b). Such coevolution requires that pre-existing sensory structures can detect and respond to new CHC molecules. This basic assumption of the theory of sexual selection is supported by the observation that taste neurons normally used to detect bitter molecules also serve to detect an aversive sex pheromone (Lacaille et al., 2007). It is thus possible that taste neurons that were initially used by the fly to detect noxious food molecules (bitterness is often associated with alkaloids and toxic molecules) have been more recently used to detect inhibitory sex pheromones. 

The definition of a process based on biotechnology is sufficiently broad to capture a wide arrange of medicinal products, such as recombinant proteins and gene-based therapeutics, and prophylactics, such as gene transfer medicinal products and DNA vaccines. Medicinal products manufactured by biotechnological processes as defined in the Annex to Regulation (EC) 726/2004 must be authorized centrally pursuant to article 3 of the Regulation. 

Transepidermal water loss (TEWL) is a natural occurrence that takes place in the skin layers. TEWL is the result of movement of water from the deep skin layers across the epidermis into the outside atmosphere. It is a tightly regulated process that is controlled by the stratum comeum [9], Occlusive topical bases and devices, such as transdermal patches, block TEWL and cause increased hydration of the skin. Hydration of the skin increases the permeation rates of compounds transdermally. The occluding effect of transdermal patches is an important mechanism that promotes increased diffusion of the compound across the skin into the systemic circulation [10]. 

Figure 2.7 Process-based compared with product-based regulation [238].

Additionally, subsequent analysis of the materials for compliance to various regulations is based on solvent extraction protocols followed by GC/FID (flame ionization detector) analysis. These protocols are generally based on specific target compounds that are regulated rather than analysis for all compounds present. From our experience we have documented many problems related to such an approach. The following case studies emphasize the need for thoroughly analyzing materials for suitability early on in the developmental process. 

In a way, this possibility to have process-based inspections for certain study types instead of study-based ones being performed by Quality Assurance may have seemingly been contradicted by the GLP Regulations of the US... 

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