title: Safety pharmacology in 2010 and beyond: survey of significant events of the past 10 years and a roadmap to the immediate-, intermediate- and long-term future in recognition of the tenth anniversary of the Safety Pharmacology Society.
abstract: In recognition of the tenth anniversary of the Safety Pharmacology Society (SPS), this review summarizes the significant events of the past 10years that have led to the birth, growth and evolution the SPS and presents a roadmap to the immediate-, intermediate- and long-term future of the SPS. The review discusses (i) the rationale for an optimal non-clinical Safety Pharmacology testing, (ii) the evolution of Safety Pharmacology over the last decade, (iii) its impact on drug discovery and development, (iv) the merits of adopting an integrated risk assessment approach, (v) the translation of non-clinical findings to humans and finally (vi) the future challenges and opportunities facing this discipline. Such challenges include the emergence of new molecular targets and new approaches to treat diseases, the rapid development of science and technologies, the growing regulatory concerns and associated number of guidance documents, and the need to train and educate the next generation of safety pharmacologist.
authors.affiliation: Global Discovery Sciences Support, Discovery & Preclinical Sciences, Merck Research Laboratories, 33 Avenue Louis Pasteur, MS: BMB 6-101, Boston, MA 02115, USA. alan.bass@merck.com
authors.forename: Alan S
authors.initials: AS
authors.lastname: Bass
authors.forename: Hugo M
authors.initials: HM
authors.lastname: Vargas
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Valentin
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Kinter
authors.forename: Tim
authors.initials: T
authors.lastname: Hammond
authors.forename: Rob
authors.initials: R
authors.lastname: Wallis
authors.forename: Peter K S
authors.initials: PK
authors.lastname: Siegl
authors.forename: Keiji
authors.initials: K
authors.lastname: Yamamoto
mesh_terms: D000818:Animals; D055808:Drug Discovery / Q000379:methods; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D018570:Risk Assessment / Q000379:methods; D012957:Societies, Pharmaceutical; D018675:Toxicity Tests / Q000639:trends