(one) An evidence why the sponsor's compliance Using the prerequisite is unneeded or cannot be realized;It does not have to have preclinical and medical trials but have to demonstrate bioequivalence by bioavailability and bioequivalence studies. The ANDA contents and evaluation system are outlined according to the Frequent Technical Doc structure i

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บทความ: กู้ข้อมูล - วิธีและเครื่องมือที่ดีที่สุดในการกู้ไฟล์ที่หายไปอย่างมืออาชีพในยุคดิจิทัลที่ข้อมูลมีความสำคัญเทียบเท