The potential deleterious effects of extractables/leachables in pharmaceutical products led the USP, EP and JP to require extractable and toxicity testing of container/closure systems. To that, a HS-GC/FID method was developed and validated for the determination of hexane as potential extractable residue from pharmaceutical container closure system into eye drops solutions. A migration study wa...

Concerns about the pharmaceutical industry's influence in academic medical centers and on medical education have led many medical schools and teaching hospitals to adopt conflict-of-interest (COI) policies. Although the restrictiveness of these policies differs, the goal is the same: to shield physicians-in-training from the persuasive aspects of pharmaceutical promotion. But do these policies ...

We develop and estimate a model of market demand for a new pharmaceutical, whose quality is learned through prescriptions by forward-looking physicians. We use a panel of antiulcer prescriptions from Italian physicians between 1990 and 1992 and focus on a new molecule available since 1990. We solve the model by calculating physicians' optimal decision rules as functions of their beliefs about t...

The problem of 'no fault' compensation for patients who suffer adverse effects as a result of their participation in clinical trials is discussed in the light of the guidelines issued by the Association of the British Pharmaceutical Industry (ABPI) and our recent experiences in reviewing protocols submitted to the local ethics of surgical research sub-committee. We have found a variety of quali...

The American Society of Health-System Pharmacists (ASHP) believes that clinical pharmacokinetic monitoring is a fundamental responsibility of all pharmacists providing pharmaceutical care. Clinical pharmacokinetic monitoring is an integral component of pharmaceutical care for selected patients based on their specific pharmacotherapy, disease states and related factors, and treatment goals. ASHP...

Drug development performance is examined using data on clinical research projects of 10 pharmaceutical companies. In contrast to previous work on the discovery phase of pharmaceutical R&D we find a strong correlation between the diversity of firms' development efforts and the success probability of individual projects, but no effect of scale per se. Large firms' superior performance in drug dev...

BACKGROUND Osteochondral injuries constitute an entity that is widespread and can be seen in patients of all ages. Actual treatment modalities aim to relieve pain, obtain full range of movement of the joint, and improve the quality of life. There are many slow-acting chondroprotective agents prevalently used in the United States that are classified as nutritional support but not as medicines . ...

Pharmaceutical industry is currently undergoing a transient phase with new orientation. Loss of financial resources, presence of new therapeutic agents and increasing cost of research and development have called for a full.scale restructuring within the pharmaceutical industry to retain even the most basic competitiveness. The development of new technologies has been as one way out of the dile...