Clinical evaluation, drugs scientists

Since quinidine has many effects on living systems, its use as a therapeutic agent is associated with many toxic or undesirable actions. For years the search for a better agent has continued. Basic scientists identified the actions of quinidine on the heart, and many representatives of the pharmaceutical industry synthesized and evaluated a host of chemicals with similar actions. However, to my knowledge, no clinically superior drug ever resulted. Only recently have we begun to understand why. 

The book addresses an audience with basic knowledge in clinical pharmacology, PK and PD, and clinical drug development. It is intended as a resource for graduate students, postdocs, and junior scientists, but also for those more experienced pharmaceutical scientists that have no experience in the PK and PD evaluation of biotech dmgs and wish to gain knowledge in this area. 

Pharmacology is the same science whether animal or man is investigated. The need for it grows rapidly as not only scientists, but now the whole community, can see its promise of release from distress and premature death over yet wider fields. The concomitant dangers of drugs (fetal deformities, adverse reactions, dependence) only add to the need for the systematic and ethical application of science to drug development, evaluation, and use, i.e. clinical pharmacology. 

An lOM committee examined the role of women in clinical trials—a complicated issue involving scientists, industry, and ethicists who evaluated the participation of women, particularly women of childbearing age, in drug trials. 

Once the clinical and safely evaluation studies for a new medicinal product have shown it to be safe, effective and of acceptable quality, the pharmaceutical company will usually want to submit a Marketing Authorisation Application (MAA) or New Drug Application (NDA) to the regulatory authorities. The chemistry, manufacturing and controls (CMC) section will form a major part of the application. For an MAA in Europe, a development pharmaceutics section is required to describe how the product was developed, and to explain the rationale for the selection of the formulation, pack, manufacturing process and specifications. Also required for Europe are expert reports for each of the pharmaceutical, safety and clinical parts of the application. These have to be written by experienced scientists nominated by the pharmaceutical company who have to critically appraise the development programme for the product. The pharmaceutical expert must acknowledge the acceptability of the CMC part of the application. 

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