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The role of outsourcing in antibody drug manufacture

European Pharmaceutical Review

A study investigating the trend for existing pharmaceutical companies to outsource to contracted development and manufacturing organisations (CDMOs), analysing the position of companies manufacturing monoclonal antibody drugs (mAbs). Yoshiura et al. Yoshiura et al.

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Pulse Infoframe Releases Registry for Patient Advocacy Groups

pharmaphorum

Alongside its support for research carried out by patients, advocacy groups, pharmaceutical companies, and academic medical centers, Rare Central also enables scientists and researchers to study deidentified data across a family of diseases with the appropriate governance structure and data sharing in place.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

Herbal medicines placed on the market since April 2011 must have either a traditional herbal registration (THR) or a Marketing Authorisation (MA). The intricate nature of botanical products further compounds the challenge, demanding a paradigm shift in regulatory interpretation and QC standards. 2012/1916).

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Tracking the Drug Trail

Pharmaceutical Technology

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. Europe is favouring 2D data matrix codes to encode information while the US is tending more towards RFID. .

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Overview of pharmaceutical quality control steps and implementations

GMPSOP

FDA – Process Validation Guidelines (published in January 2011) are crucial for maintaining the quality management system. Prev PREVIOUS POST Author: Kazi Hasan Kazi is a seasoned pharmaceutical industry professional with over 20 years of experience specializing in production operations, quality management, and process validation.

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Thyroid Antibodies Part 2: Mechanisms to Reduce Thyroid Antibodies

The Thyroid Pharmacist

In a study done in 2010, NAC and 15-Deoxy-Prostaglandin J2 (a fatty acid compound with antioxidant and anti-inflammatory properties) exerted a protective effect against autoimmune thyroid destruction in vivo. [47] 2011-0228 [2] Müssig K, Künle A, Säuberlich AL, et al. 2011-3350 [19] Eschler DC, Hasham A, Tomer Y. doi:10.1210/jc.2011-0228

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