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Guide: Providing referenceable technical specifications for clinical pharmacokinetic research of therapeutic protein drugs - CDE issues a notice on public consultation with the Guidelines for Clinical Pharmacokinetic Research of Therapeutic Protein Drugs (Draft for Comments).
the "Guidelines for Clinical Pharmacokinetic research of therapeutic protein drugs (draft for comments)" for comments feedback form, as follows: Annex I: "Guidelines for Clinical Pharmacokineticresearch Research Of Therapeutic Protein Drugs (Draft for Comments)" (Request for Comments) Annex II: Guidelines for Clinical Pharmacokinetic research of therapeutic protein drugs (draft for comments) draftnotes.docx.