ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. The results of the risk assessment are used to define experiments. July–August 2020).

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ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. The results of the risk assessment are used to define experiments. July–August 2020).

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Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. EFPIA White Paper on CMC Development, Manufacture and Supply of Pandemic COVID-19 Therapies and Vaccines.” Adopted January 2023.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

Pharmaceutical Technology

FEBRUARY 23, 2023

Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound. How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably.

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Pharmaceutical Technology

MARCH 6, 2023

Teijin Pharma is laying the foundation for quickly delivering a new therapy for patients globally by licensing the investigational compound to Novartis. It stated that the candidate is believed to impact the pathogenesis of several kidney diseases and works in a genetically validated pathway.

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Compounding Communication 105

Pharmaceutical Technology

MARCH 20, 2023

These are mainly all those with a compound in BioNTech’s pipeline. Under the deal, the two companies will co-develop OncoC4’s ONC-392, an anti-CTLA-4 monoclonal antibody candidate, as a monotherapy or as a combination therapy with anti-PD-(L)-1 antibodies in several solid tumour indications, including NSCLC.

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Compounding Communication FDA 98

Pharmaceutical Technology

MARCH 22, 2023

When it comes to highly sensitive large-molecule drugs, sourcing premium elastomeric components with a cleaner compound, such as Datwyler’s FM457, is an essential step in reducing the E&L risk. Another step is to source the highest quality components available on the market.

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Packaging Compounding Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

DECEMBER 15, 2022

From alcohols to quaternary ammonium compounds, each type of agent has a unique mode of action, with varying degrees of efficacy. With many classes of antimicrobial agents on the market, it can be difficult to choose the right one for a new formulation. There are many other aspects to take into consideration.

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Documentation Compounding Communication Pharmaceutical Companies 52

Pharmaceutical Technology

DECEMBER 26, 2022

Faster innovations and continual growth spell benefits for consumers, and these benefits can be compounded, with scope to offer more granularity of services. For example, during the pandemic, companies were facing mass deferrals which required the ability to quickly scale.

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Pharmaceutical Technology

DECEMBER 21, 2022

Faster innovations and continual growth spell benefits for consumers, and these benefits can be compounded, with scope to offer more granularity of services. For example, during the pandemic, companies were facing mass deferrals which required the ability to quickly scale.

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