European Pharmaceutical Review

JULY 5, 2023

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

Packaging 76

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 76

European Pharmaceutical Review

DECEMBER 13, 2022

There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. Tamper‑evident packaging is also recommended to prevent adulteration or contamination of the excipient. Pharmacopoeia guidance on DEG and EG. 3 Furthermore, the European Commission (EC) stated that “up to 0.1% Ann Intern Med.

Compounding 94

Compounding FDA Packaging 94

Pharmacy Friday Pearls

AUGUST 29, 2022

2007 Prospective observational review (n=7) 50 mL of 50% IV dextrose was followed by a loading dose (1 unit/kg) of IV short-acting insulin and a insulin maintenance infusion (0.52.0 Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Greene et al., High-dose insulin., Beta Safe Than Sorry! Cole, Ann M.

Packaging 52

Packaging Documentation 52

pharmaphorum

APRIL 11, 2022

Garabedian and his team plan to support VivoSense, not just with their funding package but with their industry network and connectivity. “We He served as the President and CEO of Sarepta Therapeutics from 2011 to 2015 and led corporate strategy for Celgene from 2007 to 2010 ( see more on LinkedIn ). This brings us to VivoSense.

Pharmaceutical Companies 106

Pharmaceutical Companies Pharmaceutical Companies Packaging 106

The People's Pharmacy

MAY 8, 2023

“The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.” In 2007 and 2008, hundreds had allergic reactions, some fatal, to a commonly used blood thinner, prompting an FDA investigation.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

ISPE

MARCH 8, 2023

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

PharmaShots

APRIL 25, 2023

Founded Year: 2007 Total Employees: ~100 Headquarters: Pennsylvania, United States Market Cap: $477.1M Through the 2019 agreement, Mallinckrodt received the exclusive worldwide license to Silence’s SLN500. Currently, Mallinckrodt is focused on developing RNAi therapies, SLN501, SLN-MNK-2, and SLN-MNK-3 under its development pipeline.

HIV Treatment and Prevention Agents 40

HIV Treatment and Prevention Agents Packaging Immunization Vaccines 40