PubMed · 7267241
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R E Kauffman, A S Dajani. 1981. Chloramphenicol study questioned.. https://pubmed.ncbi.nlm.nih.gov/7267241/
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The European Union's (EU) centralized procedure for new drug review was implemented in 1995 to unify the regulatory process and provide EU-wide marketing authorizations for innovative medicinal products. Goals were instituted to ensure the timeliness of the various steps of the process. The EU approved 27 biopharmaceutical products through the centralized procedure during 1995-1999. This study documents the success of the EU in meeting the timeline goals for the group and for separate categories of biopharmaceuticals (recombinant proteins, monoclonal antibodies, and antisense oligonucleotides). A subset of the 27 biopharmaceuticals approved in the EU were also approved in the United States (US). We compared EU and US approval times for these products by product category and by review status (exceptional/non-exceptional circumstance in the EU and priority/standard in the US).
The theory of nonlinear dynamical systems (chaos theory), which deals with deterministic systems that exhibit a complicated, apparently random-looking behavior, has formed an interdisciplinary area of research and has affected almost every field of science in the last 20 years. Life sciences are one of the most applicable areas for the ideas of chaos because of the complexity of biological systems. It is widely appreciated that chaotic behavior dominates physiological systems. This is suggested by experimental studies and has also been encouraged by very successful modeling. Pharmacodynamics are very tightly associated with complex physiological processes, and the implications of this relation demand that the new approach of nonlinear dynamics should be adopted in greater extent in pharmacodynamic studies. This is necessary not only for the sake of more detailed study, but mainly because nonlinear dynamics suggest a whole new rationale, fundamentally different from the classic approach. In this work the basic principles of dynamical systems are presented and applications of nonlinear dynamics in topics relevant to drug research and especially to pharmacodynamics are reviewed. Special attention is focused on three major fields of physiological systems with great importance in pharmacotherapy, namely cardiovascular, central nervous, and endocrine systems, where tools and concepts from nonlinear dynamics have been applied.