By Shayne Cox Gad
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Extra resources for Pharmaceutical Manufacturing Handbook: Production and Processes (Pharmaceutical Development Series)
Example text
In spite of these limitations, ICH Q5C does provide relevant guidance in illustrating the flexibility required for determining storage conditions, as these products usually require a very narrow temperature condition to maintain optimal stability. Further guidances may be needed to enhance uniformity in testing methodology and enable the utilization of validated PAT methodologies. 1 QUALITY BY DESIGN AND SCALE-UP Unit Operations Unit operations are defined as the individual basic steps in a process that when linked together define the process train and result in the final product.
This information will give an idea of the reliability of the methodology and equipment used under the rigors of largescale manufacturing. 4 FORMULATION DEVELOPMENT The previous sections have highlighted some of the limitations and difficulties in developing biotechnology-derived pharmaceuticals. Although there are major technological limitations in working with these products, their synthesis and manufacturing are significantly more reproducible compared to naturally derived biologics. Determining the most appropriate route of administration and subsequent formulation is dependent on a number of factors, including the product’s indication, duration of action, pharmacokinetic parameters, stability profile, and toxicity.
Exp. , 275, 537–543. 24. Anderson, P. , and Sorenson, M. A. (1994), Effects of route and formulation on clinical pharmacokinetics of interleukin-2, Clin. , 27, 19–31. 25. , Ryan, M. , and Duckworth, W. C. (1984), The renal metabolism of insulin, Diabetologia, 27, 351–357. 26. , and Maack, T. (1977), Renal extraction, filtration, absorption, and catabolism of growth hormone, Am. J. , 233, F185–F196. 27. Carone, F. , and Peterson, D. R. (1980), Hydrolysis and transport of small peptides by the proximal tubule, Am.