Ther Innov Regul Sci
An Overview of the Drug Registration Requirements for Export to Tanzania, Nepal, and Cambodia.
Shelke TV, Khante S, Sarda MB, Mahadik KR, Gaikwad VL
In the semiregulated market, different countries have varying requirements of registration for export to such a specific country or region. The object ...
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Source: PubMed
Ther Innov Regul Sci
Efficient Design of Integrated and Adaptively Interlinked Protocols for Early-Phase Drug Development Programs.
Coates S, Pohl O, Gotteland JP, Täubel J, Lorch U
Adaptive trial designs have the potential to address common challenges in drug development; they decrease timelines and costs of early drug developmen ...
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Source: PubMed
Ther Innov Regul Sci
Determinants of Generic Drug Substitution in the United States.
Segal JB, Onasanya O, Daubresse M, Lee CY, Moechtar M, Pu X, Dutcher SK, Romanelli RJ
Some classes of drugs have lower than optimal uptake of generic products. We aimed to understand the determinants of generic drug substitution across ...
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Source: PubMed
Ther Innov Regul Sci
Statistical Methods for Clinical Study Site Selection.
Xu J, Huang L, Yao Z, Xu Z, Zalkikar J, Tiwari R
The US Food and Drug Administration conducts on-site inspections and data audits through Bioresearch Monitoring program for assurance of the quality a ...
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Source: PubMed
Ther Innov Regul Sci
Regulatory Issues of Voluntary Certification of Food Supplements in Russia.
Lozda R
When registering food supplements in Russia, restrictions on the labeling and consumer leaflet contents are tightly controlled by the regulatory agenc ...
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Source: PubMed
