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Pharmaceutical Intermediates
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Active Pharmaceutical Ingredients
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Food Additives
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Pharmaceutical Intermediates
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Drug Evaluation Center of the State Drug Administration
September 26, 2021
Relevant attachments
Serial number | accessory name |
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1 | Attachment 1 Questions and Answers on the "Technical Guidelines for the Human Bioequivalence Research of Chemical Drug Generic Drugs with Pharmacokinetic Parameters as Endpoint Evaluation Index" on the multi-spec exempt BE pharmacy evaluation standard "prescription ratio similarity" (solicited) Opinion Draft 2). |
2 | Attachment 2 Questions and Answers to my country’s "Technical Guidelines for Human Bioequivalence Research of Chemical Drug Generic Drugs Using Pharmacokinetic Parameters as Endpoint Evaluation Indexes" on multiple specifications exempted BE pharmacy evaluation standards "prescription ratio similarity" related questions ( Draft for Solicitation of Comments 2)" Drafting Instructions. |
3 | Attachment 3 Questions and Answers to my country’s "Technical Guidelines for Human Bioequivalence Research of Chemical Drug Generic Drugs with Pharmacokinetic Parameters as Endpoint Evaluation Index" on the multi-specification exempt BE pharmacy evaluation standard "prescription ratio similarity" related questions ( Draft for Solicitation of Comments 2) "Feedback Form. docx |