Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency The 9 page temporary guideline emphasizes to evaluate/monitor the following in the COVID-19 public emergency to ensure drug quality. Impact of manufacturing/testing deviations in the final product ...

Abstract Background Tumor mutational burden (TMB) has both prognostic value in resected non-small cell lung cancer (NSCLC) patients and predictive value for immunotherapy response. However, TMB evaluation by whole-exome sequencing (WES) is expensive and time-consuming, hampering its application in clinical ...

Therapeutic Index : A ratio that compares the blood concentration at which a drug becomes toxic and the concentration at which the drug is effective. The larger the therapeutic index (TI), the safer the drug is. Narrow therapeutic index drugs are drugs where small differences in dose or blood ...

An ANDA suitability petition is a petition (request) to FDA to permit the filing of an ANDA for a drug that differs from the RLD.  Certain differences between a reference listed drug (RLD) and a proposed generic drug product may ...

The formula for calculating an endotoxin limit in parenterals is generally noted as K/M, where K = the Threshold Pyrogenic Dose and M is the dose of drug units/kg/hr. “K”, the numerator of the endotoxin limit formula, is the Threshold Pyrogenic Dose (TPD). ...

Issuing a statement the SII said, “Presently, the government has granted us permission to only manufacture the vaccine and stockpile it for future use. ‘COVISHIELD’will be commercialised once the trials are proven successful and all the requisite regulatory approvals are ...

In general: Level 1 guidances set forth the agency’s initial interpretations of new significant regulatory requirements; describe substantial changes in FDA’s earlier interpretation or policy; and deal with complex scientific or highly controversial issues. Level 2 guidances usually address existing ...