PRINCETON, NJ – 2018 年 5 月 29 日 – Certara today announced its participation in 28 sessions at the Population Approach Group in Europe (PAGE) 2018 Annual Meeting. PAGE is a UK-based, nonprofit organization, which is committed to taking a population approach to data analysis.
This webinar introduced the importance of bioanalysis and its downstream effects on clinical development and clinical pharmacology.
As your partner for drug development and regulatory strategy, Certara has expanded its services to offer GLP-compliant pre-clinical PK/TK NCA analysis and reporting.
The US Food and Drug Administration (FDA) has set 2018 年 5 月 5 日 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs (INDs)—in the electronic Common Technical Document (eCTD) format. A DMF provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, … Continued
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