pharmaphorum

FEBRUARY 18, 2021

Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. They employed hundreds of new salespeople to detail doctors and hospitals, spent millions on TV and magazine ads and handed out masses of free samples. 13 They launched a huge effort to transition PRILOSEC patients their newer product NEXIUM.

Prescription Filling 52

Prescription Filling Compounding FDA Communication 52

pharmaphorum

FEBRUARY 12, 2021

This may be compounded by a misconception that the field is mature, with the first discoveries having been made in the 1970s. George Underwood is the editor for pharmaphorum’s Deep Dive digital magazine. “It’s not always as obvious a path for STEM students as other disease areas,” says Chaddock. “It’s About the author.

Compounding 106

Compounding 106

pharmaphorum

MAY 7, 2021

For nearly 25 years, Jeremy has focused on aiding the biopharmaceutical and health sciences industry in the development of key compounds and new therapies. George Underwood is the editor for pharmaphorum’s Deep Dive digital magazine. About the author.

Compounding 127

Compounding 127

ISPE

OCTOBER 26, 2022

From a regulatory perspective, the only products that are to be excluded are sensitizing agents, including penicillins and cephalosporins (beta-lactams); potentially genotoxic compounds; and potentially OEB 5 compounds where the risk assessment indicates the compound cannot be adequately controlled. 2 European Commission.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

OCTOBER 27, 2022

Broad pipelines require facilities to be designed with a large degree of flexibility to support anything from mild reaction conditions to the use of potent or highly biologically active compounds. Large walk-in fume hoods are organized to support a variety of unit operations. Cell & Gene Therapy. Unlock Access to Member-Only Content.

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

ISPE

MAY 9, 2023

Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. Accessed 6 July 2022.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 6, 2023

Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

ISPE

MARCH 29, 2023

The initial risk assessment is based on information on the target compound as well as prior knowledge and experience from other products with similar characteristics. The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

The initial risk assessment is based on information on the target compound as well as prior knowledge and experience from other products with similar characteristics. The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Each issue of Pharmaceutical Engineering magazine features thought-provoking content that is available to Members only, but NOW we're giving you exclusive access to see what you've been missing out on.

Documentation 52

Documentation FDA Packaging Communication 52