New Drug Development And Review

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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