Preclinical pharmacology and

Gabizon A., Sulkes, A., Peretz, T., Druckmann, S., Goren, D., Amselem, S., and Barenholz, Y. (1989). Liposome-associated doxorubicin Preclinical pharmacology and exploratory clinical phase, in Liposomes in the Therapy of Infectious Diseases and Cancer. (G. Lopez-Berestein and I. J. Fidler, eds.), Alan R. 

Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines (CPMP/SWP/4654/95). June 1998. 

Division of Clinical Trial Design and Analysis Preclinical pharmacology and toxicology Clinical trial design, safety and efficacy 20% of CBER clinical protocols are now for gene therapy. 

Preclinical pharmacology and toxicology of candidate agent 226086. Quarterly Report.1 Mar. 1966 - 1 Sept 1966. Contract No. EA 18-108-... 

Furfine, E. S., Baker, C. T., Hale, M. R., Reynolds, D. J., Salisbury, J. A., Searle, A. D., Studenberg, S. D., Todd, D., Tung, R. D., and Spaltenstein, A. (2004). Preclinical pharmacology and pharmacokinetics of GW433908, a water-soluble prodrug of the human immunodeficiency virus protease inhibitor amprenavir. Antimicrob. Agents Chemother. 48 791-798. 

Vaccines (excluding DNA or viral vector vaccines) CPMP/SWP/465/95 Preclinical pharmacological and toxicological testing of vaccines [31] 1997... 

As mentioned above, preclinical pharmacology and toxicology for plasma derivatives has not included preclinical assessments commonly employed for small-molecule drug products. Most preclinical development involves comparative pharmacokinetics and the use of animal models has been an important component of this evaluation. The coagulation factors have shown the potential for efficacy in animal models such as the von Willebrand swine and hemophilic dog [16,17],... 

All vaccines European Medicines Evaluation Agency (EMEA) notes for guidance of preclinical pharmacological and toxicological testing of vaccines 1997... 

Safety of the product itself for the target organism, the user (who applies it) or the environment is addressed by a range of preclinical and clinical assessments which depend on the product and its use pattern. The range of safety features to be assessed includes local and systemic tolerance, acute and chronic toxicity, mutagenicity and tumorigenicity, reproductive toxicity, immunotoxicity and, for veterinary medicinal products, also the ecotoxicity. The safety tests will be described in more detail in a separate chapter below on preclinical pharmacological and safety test procedures. 

Notifications or applications for clinical trials are supported by summaries or full reports on the preclinical pharmacology and safety assessment. The kind of safety data (e.g. the type and duration of toxicity tests), which are expected at this time, should correspond to the intended route and duration of application. Data on process details and on the quality of the product are not always required. But it must be kept in mind that clinical trials can only render useful results for the later product registration, if the quality characteristics of the tested product and its method of production are the essentially same as for the final product. If available, clinical data from trials in other countries must also be provided. Protocols for the intended clinical trials are an essential part of the application. 

Preclinical pharmacological and toxicological safety assessment in animals. 

Characterization, Preclinical Pharmacology, and Preliminary Clinical Data... 

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