Pharmaceutical companies protocols

Fig. 2.2 Attrition rate in the current pharmaceutical discovery protocol. These estimates are for illustrative purposes exact figures are difficult to average across the industry, as most companies do not disclose screening success/failure rates. Modified from [12] with permission.

Should a study subject suffer any deterioration in health or well-being caused by participation in a study, the sponsors of the clinical research must provide appropriate compensation without regard to the question of legal liability. A statement to that effect should be present in the protocol. Frequently, the insurance policy of the sponsor includes the pharmaceutical company, clinical investigators and the institution where the clinical study is being undertaken. 

Most pharmaceutical companies will have their own format for a protocol. Independent investigators will adopt their own or their institution s... 

In order to encourage pharmaceutical companies to invest in orphan drug development, legislation provides for a number of incentives. These include application fee waiver (the extent of reduction varies with the region of the world, and in the European Union it is 50% for all fees since 2002), market exclusivity and protocol assistance. In the European Union, there is 100% reduction in the fee applicable to the provision of any scientific advice. The fund made available by the Community for fee exemptions for orphan medicinal products amounts to= 3 700000 in 2005. 

There is serious shortage of medically qualified personnel in Japanese pharmaceutical companies, or worse is the fact that they do not recognise the importance of such expertise in-house. The new GCP requires sponsoring companies to either employ or contract medical professionals in order to obtain medical advice in preparing protocols and conducting clinical trials. 

The IQ phase will be executed with personnel of the supplier of a technical system or with technical personnel of the pharmaceutical company. It will follow the procedures set out in the IQ protocols. After performing the IQ, the results are summarized and documented in an IQ report. 

In analyzing the full dossier, the FDA may request site visits at the pharmaceutical company and form special review committees to gain additional expertise. If additional information is needed, the sponsor must provide it, possibly requiring design of another phase III protocol or other test. A smooth NDA may be completed within 12 months. Once all FDA requests have been satisfied, the NDA is approved. The sponsoring pharmaceutical company may then market the drug. 

Department established in April 1997. Pharmaceutical companies have started to consult this department on their development plans, clinical trial protocols, necessary studies, etc., with fees (See Table 2). 

Metabonomics is now recognized as an independent and widely used technique for evaluating the toxicity of drug-candidate compounds, and has been adopted by several pharmaceutical companies into their drug development protocols. It is possible to identify the target organ toxicity, derive the biochemical mechanism of toxicity, and determine the combination of... 

Nevertheless, the development of production methods remains a challenging problem. One of the main difficulties limiting progress in this field is the restricted amount of experimental data available for model development. Moreover the data that are usually available for modeling are frequently incompatible due to the differing experimental protocols used. A larger amount of data is available in pharmaceutical companies, but these data are usually not publicly available for external use and model development. 

The structure of an IND application is contained in the regulation and is quite easily followed. Almost all pharmaceutical companies, contract research organizations and universities have templates for the writing of these documents. All the animal data, the proposed clinical study protocol, a clinical investigators brochure and the chemistry and manufacturing controls must be described. 

In addition to such forms of publication, it should be noted that health authorities in the United States and other countries are also informed as to the design and goals of all clinical trials conducted by pharmaceutical companies, and are sent final protocols prior to the study investigator meetings. This allows time for these health authorities to comment on the same and suggest modifications to the design of trials, if needed, based on their specific scientific goals. In addition, communication of safety... 

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