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Latest Developments in Safety Pharmacology

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Drug safety has become one of the most hotly debated topics in therapeutic drug development and approval. In particular, cardiovascular safety has been a focus, with several high-profile withdrawals from the market stimulating debate over the best way to measure efficacy while ensuring protection of the ...

Drug safety has become one of the most hotly debated topics in therapeutic drug development and approval. In particular, cardiovascular safety has been a focus, with several high-profile withdrawals from the market stimulating debate over the best way to measure efficacy while ensuring protection of the public health. Safety of medicine is a major concern of drug regulatory agencies, the pharmaceutical industry, contract research organizations, and academia, and is changing how the regulatory agencies evaluate new drugs. Safety pharmacology is a discipline designed to evaluate safety of test articles prior to introduction in humans. Safety Pharmacology is defined as the investigation of the potential undesirable pharmacodynamic effects of a new chemical entity (NCE) or device on physiological functions in relation to exposure in the therapeutic range and above. Studies in safety pharmacology are designed to protect subjects in clinical trials and beyond, and they often provide staff of clinical trials with hints as to how to monitor potential adverse events in man They must precede first exposure to man. The field of Safety Pharmacology is rapidly developing since the ratification of the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH S7A guidance) in November 2000. A core battery of Safety Pharmacology tests are recommended in ICH S7A/S7B and include exploration of cardiovascular function, respiratory function (e.g. plethysmography), and CNS behavior (e.g. Irwin, Functional Observational Battery). Other supplemental tests may be conducted to assess other organ systems if a need is identified. Safety pharmacologists seek to fulfill the requirements of the S7A core battery using different combinations of tests based on scientific judgement and the particularities of each drug candidate (i.e., on a case-by-case basis). Several key question about the core battery tests include: (1) which parameters of function must be explored, (2) what changes constitute concern, (3) validation of predictive value (sensitivity and specificity), (4) which species is/are useful, (5) should animal models of disease be explored because they may possess properties more propitious for manifesting adverse events, (6) does the chosen study model accurately identify the safety liability of the drug candidate? The intent of Safety pharmacology is to minimize human risk, and to minimize unnecessary removal of potentially useful drugs from the "pipe-line".


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