Drug Quality Study (DQS)

As human spaceflight expands, flight crews must have safe and effective drugs for long-duration spaceflight. In the past, crews have relied upon frequent resupply of onboard pharmaceuticals and as a result, there has been little study of the effects of long-term exposure of pharmaceuticals to the space environment. A few studies of long-term effects of space radiation on drug stability have shown that a significant number of drugs degrade.  Studies during the COVID-19 pandemic have shown that drug quality can be an issue even for pharmaceuticals that remain on Earth.  CIC Pharmaceutical Sciences presents these Drug Quality Studies to help scientists focus on the problem.

Spectrometric Assessment of Intralot and Interlot Variability in Mycophenolate Mofetil for Injection Using Near-Infrared Spectrometry and Nonparametric Subcluster Detection

Measuring Aztreonam Variations by Process Analytical Technology

Spectral Intra-Lot and Inter-Lot Variability in Methacholine

Rapid Quality Screening of Intra-lot Variability of Acetazolamide Using Near-Infrared Spectrometry

Spectroscopic Quality Monitoring of Cefepime

Fourier Transform Near-Infrared Spectrometry Reveals Significant Inter-Lot Variability in Thyrotropin Alfa (Thyrogen®) Quality

Rapid Quality Screening of Intra-lot and Inter-lot Variability of Pentamidine Isethionate Using Near-Infrared Spectrometry

NIR Spectrometry Reveals Lack of Content Uniformity in Methylprednisolone Sodium Succinate

Near-Infrared Spectrometry as a Tool for Screening Meropenem for Quality

Rapid Quality Assessment of Ceftriaxone Using Near-Infrared Spectroscopy

Potential Process Control Issues with Vasopressin

Lack of Content Uniformity in Azacitidine Vials

Application of Near-Infrared Spectroscopy for Screening of Chlorothiazide Sodium Vials

Assessment of Vecuronium Quality Using Near-Infrared Spectrometry

Potential Process Control Issues With Abatacept

Variability in Content of Hydrocortisone Sodium Succinate

Quality Variations in Thyrotropin Alfa

Spectrometric Analysis of Dantrolene Sodium

Spectral Intra-Lot and Inter-Lot Variability in Carfilzomib

Spectrometric Analysis of Process Variations in Remifentanil

Potential Process Control Issues with Pemetrexed

Variability in Content of Piperacillin and Tazobactam Injection

Lack of Content Uniformity in MMR Vaccine

FTNIR Spectrometry of Micafungin Sodium Quality

Levothyroxine Variations by Process Analytical Technology

Spectrometric Results of Process Variations in Dacarbazine

Intra-Lot and Inter-Lot Variability in Cosyntropin

Intra-Lot and Inter-Lot Variability in Ceftaroline Fosamil

Potential Process Control Issues with Remdesivir