Pharmaceutical products evaluation

During the development of pharmaceutical products, the toxic effect of biomaterials on cells is considered one of the most important issues to be evaluated. For instance, cell death, cell... 

Pharmacoeconomics is the study of the costs and consequences of pharmaceutical products and services (Bootman et al., 1991). The basic question addressed in a pharmacoeconomic evaluation is not whether to use a particular product or service, but rather when and under what circumstances a particular intervention is efficient. Rather than focusing on just product cost, pharmacoeconomics examines the total economic impact of a pharmaceutical product on the health care system. The value of pharmaceuticals is determined by balancing the health system costs and consequences (outcomes) of its use. 

In 1995, Prescrire International, a French journal that evaluates pharmaceutical products, published a review that concluded "As homeopathic treatments are generally used in conditions with variable outcome or showing spontaneous recovery (hence their placebo responsiveness), these treatments are widely considered to have an effect in some patients. However, despite the large number of comparative trials carried out to date there is no evidence that homeopathy is any more effective fhan placebo therapy given in identical conditions." ... 

The approaches and strategies presented in this chapter are intended to overcome these issues for CE methods. Recendy a more advanced approach toward chromatographic method development was introduced in pharmaceutical product development that also is beneficial for CE methods. In the advanced approach (i) the voice of the customer is captured, (ii) key process input variables are identified, (iii) critical to quality (CTQ) factors are determined, (iv) several method verification tests are installed, (v) proactive evaluation of method performance during development is performed, (vi) continuous customer involvement and focus is institutionalized, and (vii) method capability assessment (suitability to be applied for release testing against specification limits) is established. 

During the last few years, a number of specific monographs for different pharmaceutical products have appeared in pharmacopoeias in which CE is prescribed as one of the analytical procedures. Several comparative studies have been reported in which established analytical procedures described in pharmacopoeial monographs were compared with capillary electrophoretic methods or in which CE was evaluated as a valuable additional technique.Based on the results, some analytical procedures have been replaced by CE-based alternative methods in a number of monographs. For other products, CE has been included in the monograph from the initial version onwards. In addition, CE has been applied... 

In the evaluation of pharmaceutical products, commonly used surrogate efficacy endpoints include ... 

Confidence from Phase I and Ila trials that further evaluation of a pharmaceutical product is warranted. 

Once an application has been accepted for evaluation, the Pharmaceutical Chemistry Evaluation Section, Toxicology Section and Clinical Evaluation Units evaluate the Module 3, 4 and 5 data, respectively. For applications relating to products of biological origin, a second copy of the Module 3 data is also evaluated by the TGA Laboratories (TGAL) Branch, which evaluates aspects such as laboratory methodology, method validation and shelf-life. 

More generally, any public policy that affects use of pharmaceutical products in the short run should affect innovation in the longer run. As discussed above, countries differ in their relative emphasis on cost containment by the public sector versus reliance on market forces to achieve socially desirable outcomes. A method for achieving cost containment and static efficiency in some countries has been public evaluation of the costs and benefits of new technologies. 

This approach to defining cost therefore proposes a three-step procedure for the evaluation of new pharmaceutical products. Assume that there is some threshold value V for cost per QALY that appropriately governs resource allocation. 

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