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New Drug Development and Review

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New Drug Development and Review Yeong-Liang Lin, MD, MS Center for Drug Evaluation
Information ,[object Object],[object Object],[object Object],[object Object],[object Object]
Drug Development ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CMC ,[object Object],[object Object]
Drug Substance ,[object Object],[object Object],[object Object],[object Object]
Manufacturing Process ,[object Object],[object Object],[object Object],[object Object],[object Object]
Process Controls ,[object Object],[object Object],[object Object],[object Object]
Characterization ,[object Object],[object Object]
Control of Substance ,[object Object],[object Object],[object Object],[object Object]
Drug Product ,[object Object],[object Object]
Pharmacology ,[object Object]
Safety Pharmacology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Toxicology Studies ,[object Object],[object Object],[object Object],[object Object],[object Object]
Toxicology ,[object Object],[object Object],[object Object]
Toxicology Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Biopharmaceutic Studies ,[object Object],[object Object],[object Object],[object Object]
Background Studies ,[object Object],[object Object],[object Object]
Bioavailability Studies ,[object Object]
Pharmacokinetic Studies ,[object Object],[object Object],[object Object],[object Object]
In Vitro Studies ,[object Object],[object Object]
Drug Interaction Studies ,[object Object],[object Object],[object Object],[object Object]
PK in Patients with Organ Impairment ,[object Object],[object Object]
Clinical Trial ,[object Object]
Phase I ,[object Object],[object Object],[object Object]
Phase II ,[object Object],[object Object],[object Object]
Phase III ,[object Object],[object Object],[object Object]
Phase IV ,[object Object],[object Object]
Ethnic Factor ,[object Object],[object Object],[object Object],[object Object]
Steps ,[object Object],[object Object],[object Object]
Characterization in Foreign Populations ,[object Object],[object Object],[object Object],[object Object]
Characterization in the New Population ,[object Object],[object Object],[object Object]
Intrinsic Factors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Extrinsic Factors ,[object Object],[object Object]
Foreign Data Unacceptable ,[object Object],[object Object],[object Object],[object Object],[object Object]
Potential Hurdles ,[object Object],[object Object],[object Object],[object Object]
Review of Hepatotoxicity ,[object Object],[object Object],[object Object],[object Object]
Review of QT Prolongation ,[object Object],[object Object],[object Object],[object Object]
Conclusion ,[object Object],[object Object],[object Object],[object Object],[object Object]

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New Drug Development and Review

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