Drug development comparative

Reduction of cost of drug development. Compared to the high cost and long development time of a pharmaceutical product, a drug delivery system takes a much shorter time to develop - usually 2-4 years - and costs much less. Development for a new formulation of a generic preparation has more potential of profit in relation to investment when compared with developing a new chemical entity. 

However, compared with the traditional analytical methods, the adoption of chromatographic methods represented a signihcant improvement in pharmaceutical analysis. This was because chromatographic methods had the advantages of method specihcity, the ability to separate and detect low-level impurities. Specihcity is especially important for methods intended for early-phase drug development when the chemical and physical properties of the active pharmaceutical ingredient (API) are not fully understood and the synthetic processes are not fully developed. Therefore the assurance of safety in clinical trials of an API relies heavily on the ability of analytical methods to detect and quantitate unknown impurities that may pose safety concerns. This task was not easily performed or simply could not be carried out by classic wet chemistry methods. Therefore, slowly, HPLC and GC established their places as the mainstream analytical methods in pharmaceutical analysis. 

In this chapter, reasons why 17 drugs were withdrawn from the Western market between 1992 and 2006 are discussed and facts on 63 terminated clinical development projects presented, so as to identify the most common reasons for the failure of drugs in this late stage of drug development This analysis is then compared with two previous related studies published more than 18 years ago by Prentis et al. [4] and Kennedy [5],... 

Analytical methods are important not only in the development and manufacture of commercial biopharmaceutical drugs, they also play a vital role in the whole drug development life cycle. Drug discovery and preclinical research require development and application of analytical methodologies to support identification, quantitation, and characterization of lead molecules. It is difficult to perform a comparative potency assay on lead molecules if one does not know how much of each is going into the assay or how pure the molecule is. Analytical methods are typically developed, qualified, and validated in step with the clinical... 

In the current, price-sensitive environment, which is the hallmark of modem healthcare and certainly new drug development, expenses necessary to support clinical research are a major concern for sponsors. Both fixed and variable costs can be managed effectively compared to complete in-house development budgets. As product development costs are a significant element influencing pharmaceutical pricing, the role of innovative CROs is expected to grow. 

Because the standard template takes inputs regarding the comparative utility of freaf-ment options and calculates resulhng patient shares and associated product revenues over time, it can be used to determine how good a new compound must be to attain a certain market share target. These types of analyses often prove useful in fhe early sfages of drug development when "go, no-go" decisions are made. 

In-licensing opportxmihes can enter the drug development process at the level of phase trials and the on patent stage. In either case, the simulahon model can assign a cost necessary to obtain in-licensed compoxmds (cost per in-licensed compound), which can be compared... 

All three of these new AmB formulations improve the therapeutic index of the drug considerably compared with Fungizone. Larger cumulative doses can be given, leading to cures that were hitherto impossible. However, they are expensive and thus inaccessible in developing countries where their use would be of most benefit (13). 

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