Safety assessment nonclinical

The formulations that are developed and used for preclinical studies are sometimes specific for the test species to be employed, but their development always starts with consideration of the route of exposure that is to be used clinically and, if possible, in accordance with a specified regimen of treatment (mirroring the intended clinical protocol, as much as possible). One aspect of both nonclinical and clinical formulation and testing which presents an important but often overlooked aspect of pharmaceutical safety assessment is the special field of excipients. These will be considered at the end of this chapter... 

Nonclinical Drug Safety Assessment Frederick E. Reno 291... 

The test facilities in India and China have evolved over the years and conduct a range of nonclinical safety assessment studies for in-house drug development, and also provide service as contract research organizations (CROs) for sponsors not only from India and China but also from overseas pharmaceutical and agrochemical companies. 

The regulatory guidelines adopted for nonclinical safety assessment during drug development are primarily those of the ICH (1). The Indian regulatory system accepts any animal toxicity data generated in other countries as well. 

All drugs entering the Chinese market are approved by the state FDA (13). The nonclinical safety assessment process of pharmaceuticals in China is very similar to that of other countries. Most up-to-date data requirements for the approval of new drugs are available on the Web site of Center for Drug Evaluation (CDE) of the SFDA (http //www.sfda.gov.cn/). 

Drug Information Association. Computerized Data Systems for Nonclinical Safety Assessment Current Concepts and Quality Assurance. Maple Glen, PA Drug Information Allocation, 1980. 

The reasons for identification of metabolites are manyfold but all boil down to human safety of drugs under clinical investigation. Initially metabolites of a drug are characterized with in vitro systems (microsomes, hepatocytes, S9 fractions, etc.) and later lead compounds are assessed using mouse, rat, rabbit, dog, and/or monkey. Subsequently, metabolites in humans are identified following dmg administration to assure that the nonclinical species undergoing safety assessment are adequately exposed to human metabolites of the dmg (Smith and Obach, 2006). 

Shawn M. Heidel, DVM, PhD, Head, Nonclinical Safety Assessment, Eli Lilly and Company, Lilly Research Laboratories, PO Box 708, Greenfield, IN 46140 sheidel lilly.com... 

DIA (1988), Computerized Data Systems for Nonclinical Safety Assessment Current Concepts and Quality Assurance, Red Apple Report, Drug Information Association, Maple Green, September. BARQA (1997), Regulatory Compliance and Computer Systems, Conference Proceedings, January 7-8, Cambridge, U.K. 

Turner JR, Durham TA. Nonclinical Development Integrated Cardiac Safety Assessment Methodologies for Non-cardiac Drugs in Discovery, Development, and Postmarketing Surveillance. John Wiley Sr Sons Inc. Hoboken, New Jersey. 2009 111-134. 

Lebron JA, Wolf JJ, Kaplanski CV, Ledwith BJ. Nonclinical safety assessment of vaccines and the evaluation of novel adjuvants and delivery systems. In Vaccine Adjuvants and Delivery Systems, edited by Singh M, pp. 403-420. Hoboken, NJ John Wiley Sons, 2007. 

Curtis C. Maier, PhD, Head of Immunologic Toxicology, Department of Safety Assessment, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, UE0360, King of Prussia, PA 19406, E-mail curtis.c.maier gsk.com Chapter 8.2 Nonclinical Models to Assess Respiratory Hypersensitivity Potential... 

Safety assessment of pharmaceuticals M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals [6] Guidance for Industry Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals [7] N/A New Drugs Division Notification No. 9/99 Guidelines for Toxicity Studies of Drugs... 

Gad, S.C., Nonclinical safety assessment of the cardiovascular toxicity of drugs and combination medical devices. In Target Organ Toxicity The Cardiovascular System (D. Acosta, ed.), Philadelphia Taylor Francis, 2008, pp. 33-58. 

Sarazan, R.D., et al., Cardiovascular function in nonclinical drug safety assessment current issues and opportunities, Int.. of Toxicol., 2011,30 272-286. 

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