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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).

FDA 103
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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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CMC Requirements for New Drug Registration in Latin America

ISPE

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements. Resolution RDC 10/2011. Published 24 March 2011.

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Challenges for Net Zero Carbon Pharmaceutical Manufacturing

ISPE

link] A recent study published by My Green Lab 2 presented data from 74 biotechnology and pharmaceutical companies tracking the change in scope 1, 2, and 3 carbon intensity (measured in tons of CO2 emitted vs. the company’s revenue in USD) since 2015. For pharmaceutical companies, purchased goods (e.g.,

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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