Pharmacology at the beginning of the 21st century: implications of several new developments for dentistry and current status of the major 20th century dental drugs.

This review has highlighted some of the developments in pharmacology likely to impact dentistry as we enter the 21st century. While dentistry will naturally lag behind medicine in the introduction of new drugs, we must constantly explore all information resources available to keep abreast of developments in pharmacology that will affect our patients and our use of drugs in dental practice. This century will abound with new therapies, some of which will hopefully lead us out of our tradition of using rather non-selective, widely distributed chemicals with multiple actions and side effects into an age of highly-selective therapies, including the repair and replacement of defective genetic determinants of disease with healthy ones.

10th annual meeting of the Safety Pharmacology Society: an overview.

The 10th annual meeting of the Safety Pharmacology (SP) Society covered numerous topics of educational and practical research interest. Biopolymers - the theme of the keynote address - were presented as essential components of medical devices, diagnostic tools, biosensors, human tissue engineering and pharmaceutical formulations for optimized drug delivery. Toxicology and SP investigators - the topic of the Distinguished Service Award Lecture - were encouraged to collaborate in the development of SP technologies and protocols applicable to toxicology studies. Pharmaceutical companies, originally organizations bearing all risks for developing their portfolios, are increasingly moving towards fully integrated networks which outsource core activities (including SP studies) to large contract research organizations. Future nonclinical data are now expected to be of such high quality and predictability power that they may obviate the need for certain expensive and time-consuming clinical investigations. In this context, SP is called upon to extend its risk assessment purview to areas which currently are not systematically covered, such as drug-induced QRS interval prolongation, negative emotions and feelings (e.g., depression), and minor chronic cardiovascular and metabolic changes (e.g., as produced by drugs for type 2 diabetes) which can be responsible for delayed morbidity and mortality. The recently approved ICH S9 guidance relaxes the traditional regulatory SP package in order to accelerate the clinical access to anticancer drugs for patients with advanced malignancies. The novel FDA 'Animal Rule' guidance proposes that for clinical candidates with well-understood toxicities, marketing approval may be granted exclusively on efficacy data generated in animal studies as human clinical investigations for these types of drugs are either unfeasible or unethical. In conclusion, the core messages of this meeting are that SP should consistently operate according to the 'fit-for-purpose' principle and gradually integrate new mechanism-oriented safety paradigms into the traditional ones for ensuring more effectively the safety of drugs for any population of patients in need.

Degradable and bioresorbable polymers in surgery and in pharmacology: beliefs and facts.

The number of articles dealing with degradable polymers and macromolecules is increasing rapidly and the number of proposed compounds as well. However, not all have a high potential for effective applications. This contribution examines first the criteria to be taken into account when commercialisation of polymeric compounds and devices aimed at helping the body for a limited period of time, i.e. the healing time, is the main goal. What is really known is tentatively analysed by considering some of the candidates present in literature confronted to the targeted potential applications. Tentative comments are made on what should be done to qualify a candidate. Last but not least, trends in the search for polymers to be exploited in presently attracting areas such as bioresorbable stents, hydrogels to deliver bioactive macromolecules like proteins and polynucleotides or polyelectrolytes to temporarily complex charged biomacromolecules like proteins or genes are considered.