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Preclinical safety evaluation of biopharmaceuticals

pharmaceutical products are evaluated in humans, it is essential that they undergo a rigorous safety assessment using in vitro models and studies in preclinical species. Once products progress into the clinic, additional preclinical studies are needed to support further clinical testing. Although regulatory guidelines provide a good framework for the types of studies that should be performed, there are some areas where it is unclear how these should be applied to microbicides, what study designs should be used, whether certain tests are relevant or if additional assays are appropriate

Journals related to Preclinical safety evaluation of biopharmaceuticals 
Clinical Pharmacology & BiopharmaceuticsBiochemistry & Pharmacology: Open AccessAdvances in Pharmacoepidemiology & Drug SafetyJournal of Molecular Pharmaceutics & Organic Process Research, Biopharmaceutics & Drug Disposition, Pharmaceutical Sciences & Emerging Drugs, Journal of Pre-Clinical and Clinical Research, Austin Journal of Cancer and Clinical Research, European Journal of Clinical Pharmacy, Journal of Basic and Clinical Pharmacy.

Preclinical safety evaluation of biopharmaceuticals

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