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NIHS 医薬品安全性情報 Vol.16 No.012018/0111/

Carafate’]の製品表示が改訂され， 販売名が[‘Carafate suspension’]から [‘Carafate oral suspension’]に変更さ

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Guideline for the Development of Liposome Drug …

4 described in this document are also subject to other relevant notifications and guidelines. The active substances mentioned here include a low-molecular-weight chemical entity, a

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Guideline for Bioequivalence Studies of Generic …

1 Guideline for Bioequivalence Studies of Generic Products for Topical Use July 7, 2003 局所皮膚適用製剤の後発医薬品のための 生物学的同等性試験ガイドライン

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Guideline for Bioequivalence Studies for Different ...

2 Section 1: Introduction This guideline describes the principles of procedures of bioequivalence studies for oral solid dosage forms that contains a different quantity of the active ingredient from an

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Clinical Pharmacokinetic Studies of Pharmaceuticals

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European Medicines Agency - NIHS

What is Quality Risk Management? • Proposed ICH Q9 definition: “Quality risk management is a systematic process for the identification, assessment

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ICH Q9 ‘Quality Risk Management’ - an industry view Peter H. Gough, Eli Lilly and Company

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