Existing Formulations

For a number of liposome preparations—both injectables and locally administered products—the therapeutic advantages over existing formulations have been proven in animal models clinical trials with liposome preparations are now under way. So far, clinical studies showed no significant toxic effects which could be ascribed to the lipid components of the liposomes used. 

Bioequivalence trials are typically conducted to demonstrate that a new formulation of a drug has equivalent characteristics to an existing formulation... 

Cross-over study designs are typically employed in bioequivalence trials. Imagine that the new formulation is called N and the existing formulation is called R (the reference formulation). The two order possibilities for receiving the two drug treatments are NR and RN. Typically, healthy male and female adults participate in these studies, and the treatment orders are appropriately controlled and balanced. Pharmacokinetic parameters are used to represent both safety and efficacy. 

Limiting factor method 25 Starting with an existing formulation, the serum concentration is lowered until cell growth becomes limited then the concentration of each component of the medium is optimized until cell growth recovers. 

Some possible replacements for existing formulations based on DNAN are summarized in Tab. 2.3a... 

It is designed for multidimensional systems. This is a qualitative difference from the existing formulations which attempt to extrapolate to three or more degrees of freedom (DOF) geometrical methods that work for systems with two DOFs. 

First, the most important loads on wind turbine rotor blades are described and a brief review of fatigue research in composites is presented to place the following approach in a broader perspective. The approach described in this paper concerns modification of the existing formulations. Possible modifications are illustrated with predictions for an existing data set, which was generated by subjecting composite specimens to different variable amplitude load sequences. 

Actually, several possibilities exist formulating the wall friction force. The natural boundary layer shear stress definition to use is the one deduced from the fundamental equilibrium boundary layer analysis. The wall shear stress is thus defined as —Om =... 

Existing formulations possessing side effects due to the excipients used (e.g., Cremophor EL) could be replaced by nanosuspensions stabilized by well-tolerated excipients (e.g., lecithin, poloxamer 188). 

The documentation about the formulation should show that the intended formulation will result in a preparation with sufficient technical quality. The choice of a formulation can be based on literature sources or by referring to an existing formulation for a similar preparation. When a new formulation is designed, the chosen formulation is explained here in detail. 

From the methodological point of view to a development of CD application in pharmaceutical formulation, the way of approach seems to have been almost established. For example, in stablization or solubilization, usually the effect of the addition of CDs is examined first, and then a further investigation and evaluation of the preparation is done in comparison with the preparations without CDs or with the existing formulations. 

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