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High-Dose Insulin Euglycemic Therapy in Calcium Channel Blocker and Beta-Blocker Toxicity

Pharmacy Friday Pearls

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. 2011 Consecutive case series (n=12) Patients included if toxicology service was present to participate in management. Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Cole, Ann M.

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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. January 2011. Returning to a development process within the execution of a validation protocol can come with complexities in documentation and regulatory compliance.

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EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme

pharmaphorum

The deal was agreed well before Teva bought Cephalon in 2011 for $6.8 The two companies agreed to settle the dispute but as part of the settlement Teva received a package of commercial side-deals and cash payments. billion and involved a complex series of transactions instead of an up-front payment.

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CMC Requirements for New Drug Registration in Latin America

ISPE

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

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Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. Published September 12, 2011. Invest in a High-Quality Portable Air Filter. Paul Pestano.

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Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

ISPE

17 (2011):10083–92. addresses the risk-based decision-making process as a consequence of the previously defined level of formality, alongside the levels of effort and documentation. Barton, and B. Economic Analysis of Integrated Continuous and Batch Pharmaceutical Manufacturing: A Case Study.” doi:10.1021/IE2006752 12 Khinast, J.,