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Regulatory authorities drug development process

The emphasis at this stage of the drug development process is upon assessing safety. Satisfactory pharmacological, and particularly toxicological, results must be obtained before any regulatory authority will permit commencement of human trials... [Pg.75]

We certainly hope that this book will encourage regulatory authorities to develop new regulatory processes for independent review and use of excipients. The availability of independent review will encourage innovation and development of commercially viable new excipients. Ultimately, all this should help quickly develop lifesaving drug delivery systems benefiting humans. [Pg.469]

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See also in sourсe #XX -- [ Pg.233 ]



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