Proteins drug guidelines

U.S. Food and Drug Administration, DRAFT Guideline for Industry Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls Information, September 3, 2003. 

Since the number of recombinant protein drugs will substantially increase over the next decade, analytical as well as bioan-alytical methods for the characterization of such macromolecules will definitively gain in importance. Especially the vaKdation of bioanalytical methods is of key importance to allow an accurate description of protein drugs. This requires harmonized guidelines, which are not yet existing but seem to be on the way, to accelerate drug development. 

Thiopentone is administered as a 2.5% solution, the usual intravenous induction dose being 3-5 mg kg-1 in adults and 5-6 mg kg-1 in children. The dose necessary to induce anaesthesia is reduced by premedication, during early pregnancy and in critically ill patients. Patients over 70 years of age require a 30-40% lower dose because of a decrease in the volume of distribution, lower plasma proteins, and a slower redistribution of the drug from vessel-rich tissues. However, the above doses are merely guidelines, and the calculated dose should be administered over 10-20 seconds and the drug titrated to clinical effect, i.e. loss of eyelash reflex. 

Apte and Katdare (29) aver that new mechanisms in the form of guidelines and procedures are needed to regulate the functionality of new and emerging excipients. In the examples below, the pharmacological effectiveness of a drug can be influenced by the excipient. These new excipients may be antigens, viral vectors, microbial products, or other complex proteins. Their pharmacological activities are not completely independent of their excipient functionality and straddle the line between excipients and APIs. For example, paclitaxel bound to albumin (30) (Abraxane) improves breast cancer therapy. 

Food and Drug Administration (FDA) health claims" show that a relationship between a nutrient(s) or other substances and a disease or health-related condition, i.e., foods with soy protein, soluble fiber, and plant sterols, helps lower the risk of coronary heart disease (Table 8.5). These claims help individuals to select foods as either part of following recommended dietary guidelines, such as the TLC and Heart Healthy diets, or part of a self-treatment in response to You need to eat less fat and cholesterol and more fiber. ... 

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