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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 ... Read More

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 ... Read More

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 ... Read More

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 ... Read More

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 ... Read More

Source: PubMed

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