Drug development compliance issues

In the recently released book on worldwide compliance issues (Adherence to Long-term Therapies, Evidence for Action),7 published by the World Health Organization, researchers indicate that the problem of noncompliance is worse in countries in the developing world than in countries in the industrialized world. Many parts of the United States have similar morbidity and mortality rates as countries in the Third World.8 Specific disease states may have significant additional noncompliance ramifications due to the development of drug-resistant strains of bacteria.9 Many times what is necessary is referral to specific clinicians for individualized treatment and monitoring to enhance compliance. The case histories provided in this text will allow you to follow what others have done in similar situations to optimally help patients succeed in improving compliance rates and subsequent positive health outcomes. 

Mr GM s psoriasis has worsened. It was initially characterised by extensive reddening of the skin (which was possibly erythrodermic psoriasis) but it has progressed to a plaque psoriasis. It has failed to respond effectively to treatment so, while it is unlikely that other types of psoriasis will develop, the plaque psoriasis has, and continues to, spread across his body. However, given the drug therapies and issues of Mr GM s compliance, it is possible that initial plaque psoriasis has deteriorated into more unstable forms of the disease, such as erythrodermic psoriasis. 

The preceding three scenarios are only a few of the designs utilized globally by drug development organizations. However QA may fit in the organization, the information supplied by the group can help to identify potential issue areas and compliance failures. 

Having physiochemical properties that improve probability of success in drug development by addressing issues of absorption and bioavailability including the filtering out of chemically reactive functional groups and peptides, compliance with ROF, etc. ... 

Patients respond variably to the more than 20 FDA-approved antidepressants Only 60-70% of patients show significant response to any specific antidepressant, and there is no predictor of response to those drugs. Thus, the development of novel therapies should be geared to solve two important issues in treatment treatment resistance or refractoriness to current antidepressants, and medication compliance. 

If the findings relating to obesity and improved glycaemic control can be confirmed in human studies such drugs would be highly attractive. As discussed above, bile-acid sequestrants have been used for many years to treat dyslipi-demia in relation to reducing cardiovascular disease risk and the safety profile of these compounds is well established. However, due to the large doses of compound that require to be consumed, compliance is an issue for BAS therapies. In the future, this may be resolved with the development of more specific and efficient resins that require lower doses. 

Food and Drug Administration. Guide to Inspection of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation. Rockville, MD Office of Compliance, Center for Drugs and Biologies (Jan. 1994). 

Clavier, J.Y. Perrut, M. Scale-up issues for supercritical fluid processing in compliance with GMP. In Supercritical Fluid Technology for Drug Product Development York, P., Kompella, U.B., Shekunov, B.Y., Eds. Marcel Dekker, Inc. New York, 2004. 

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