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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

Owing to the engagements through the ETP and the addition of key personnel with experience in CM in the petrochemical industry, CDER approved the first regulatory submission incorporating CM for a small molecule drug product in 2015. End-to-end continuous processes flow from starting materials to finished dosage forms.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. At the centre of the case was Gilenya’s ‘405 patent, which details methods for treating relapsing multiple sclerosis with a specific dosage of the drug.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. 1 May 2015. Nature Communications 12, no. Journal of Biotechnology 213 (2015):120–30. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” Modular Manufacturing.” 12 April 2016.

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How Do Adaptogenic Herbs Benefit Hashimoto’s?

The Thyroid Pharmacist

I recommend that you closely monitor your thyroid symptoms, thyroid hormones, and thyroid antibodies, and test hormone levels every six to 12 weeks, to ensure your thyroid medication dosage is optimized. doi:10.1155/2015/284154 [16] Kim JH, Yi YS, Kim MY, Cho JY. 2015 Sep;28(1):459-69; Carneiro CS, Costa-Pinto FA, da Silva AP, et al.