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[]
[null,null,"先発医薬品","後発医薬品"]
["一般名"]
["医薬品名"]
["販売会社名（製造会社名）"]
["発売日"]
["規格"]
["薬価"]
["品質","科学的データ","安定性（長期保存試験・加速・過酷試験）【資】","☐有","☐無"]
[null,null,"粉砕後の安定性と簡易懸濁データ【資】","☐有","☐無"]
[null,"（内部資料）","規格試験（溶出・崩壊試験等）【資】","☐有","☐無"]
[null,null,"生物学的同等性試験（溶出比較試験・血中濃度試験《AUC,Cmax,T1/2等》）【資】","☐有","☐無"]
[null,null,"添加物（安全性・添加目的）【資】","☐有","☐無"]
[null,null,"容器・包装の材質、安全性（容器からの溶出物等）","☐有","☐無"]
[null,null,"オレンジブック収載（内服固形製剤についてのみ適用）","☐有","☐無"]
[null,null,"注射剤（ph、浸透圧等）","☐有","☐無"]
[null,"（納入時資料）","確認試験（有効成分含有量）データ添付【資】","☐可","☐不可"]
[null,"その他","GMPにかかる査察評価資料","☐有","☐無"]
[null,null,"剤形的付加価値（使用感の同等性または向上等）","☐有","☐無"]
["情報収集・提供体制","情報収集・提供体制","学術部門","☐有","☐無"]
[null,null,"PMS（市販後調査部門）","☐有","☐無"]
[null,null,"厚生労働省への有害事象報告","☐有","☐無"]
[null,null,"全MR数",null,"名"]
[null,null,"MR数（エリア数）　どこのエリアか記入","名","（　　　　　）"]
[null,null,"MR教育（MR認定試験合格率）",null,"％"]
[null,null,"緊急連絡体制（DI情報、品質クレーム等）","☐有","☐無"]
[null,null,"ホームページ開設","☐有","☐無"]
[null,null,"適応症の同一性（対先発医薬品）","☐有","☐無"]
[null,null,"インタビューフォーム","☐有","☐無"]
[null,null,"添付文書集","☐有","☐無"]
[null,null,"製品概要","☐有","☐無"]
[null,null,"患者向け服薬指導用資料（薬のしおり、使用上の注意等）【資】","☐有","☐無"]
[null,null,"配合情報等（注射剤、内服剤、外用剤等）","☐有","☐無"]
["供給体制・リスクマネジメント","企業対応","1ヶ月以上の製品在庫","☐有","☐無"]
[null,null,"製造ラインのトラブルに対するマニュアルでの回避対応","☐可","☐不可"]
[null,null,"先発と同一規格の全製品","☐有","☐無"]
[null,null,"小包装・バラ包装","☐有","☐無"]
[null,null,"特許にかかるトラブル","☐有","☐無"]
[null,null,"不良医薬品のマニュアルによる回収対応","☐可","☐不可"]
[null,null,"製造中止前、6ヶ月以上の連絡","☐可","☐不可"]
[null,null,"発売後の経過年数の長短","☐3年以上","☐3年未満"]
[null,null,"暴露リスク軽減対策（抗がん剤のみ）","☐有","☐無"]
[null,"流通対応","時間外対応（緊急注文等）","☐可","☐不可"]
[null,null,"納入時、残有効（使用）期限が1/2以上","☐可","☐不可"]
[null,null,"市場占有率",null,"％"]
[null,null,"卸経由か・直販か","☐卸","☐直"]
["安全　医療　　","製品情報","名称・色調・デザイン・形状の先発品との近似性","☐有","☐無"]
[null,null,"名称・色調・デザイン・形状の他製品との類似性","☐有","☐無"]
[null,null,"製剤見本の提供","☐可","☐不可"]
["その他","企業情報","株式上場","☐有","☐無"]
[null,null,"販売中止品目数（前年度から現在まで）",null,"品目"]
[null,null,"日薬連加盟（業態別団体名）"]
[null,null,"他施設での採用状況【資】","☐有","☐無"]
[null,null,"患者負担軽減","☐有","☐無"]
["総合評価"]
["【資】は資料添付を求める項目。　部数がないのは１部。　全てを１冊のクリアブックに用意すること。"]