European Pharmaceutical Review

DECEMBER 15, 2022

1–3 This broad class of serotonergic agents, such as psilocybin, can produce changes in sensory perception, mood and thought processes. The current trial-and-error process of treating depression takes time, with more than 100 million people around the world suffering from treatment-resistant depression.

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SEPTEMBER 11, 2023

This article provides background knowledge from literature and data from experiments to enhance the discussion. 4 Unfortunately, in the WHO version, a couple of words are different from the EU and PIC/S Annex 1 versions, i.e., “working position” versus “working level” in chapter 4.30. 5 , 6 From his research, the 0.45

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MAY 9, 2023

She noted that, historically, the Triangle has not had to deal with workers jumping from one company to another the way this happens in places like the San Francisco Bay Area, which has a nucleus of companies. As is the case with so much in the Triangle, solutions to this challenge are coming from many angles. But it does now.

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JANUARY 9, 2023

The overall approach, framework, and key concepts remain unchanged from the first edition. Since the publication of the first edition, GAMP ® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance.

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MARCH 6, 2023

The most inclusive comes from the United Nation’s 2015 Sustainable Development Goal, in which 17 categories and 169 targets promote human rights and gender equality in a balance of economic, social, and environmental concerns. while meeting patient needs as a primary goal. while meeting patient needs as a primary goal. 1 European Commission.

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MAY 9, 2023

There is a concerted effort from multinational pharmaceutical companies in developing countries to embrace regulatory convergence with international standards, primarily ICH, and to implement these standards to meet the increasing needs for and to expedite patient access to specialized and targeted medicines.

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OCTOBER 27, 2022

Resounding clinical successes and maturation of extensive therapeutic pipelines have catapulted oligonucleotides from a fringe modality to therapeutic relevance in just a few short years. Oligonucleotide Therapeutics: From Discovery and Development to Patentability.” Oligonucleotides: A Cornerstone for Therapeutics & More. Crouvezier.

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MARCH 6, 2023

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. 1 Intergovernmental Panel on Climate Change (IPCC). Finalized 9 August 2021.

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OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Business Need, Possible Modalities, and Manufacturing Scale. Outline Guiding and Segregation Principles.

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MAY 9, 2023

Thanks to years of effort from industry, pharmaceutical professionals, and education institutions, it is synonymous with pharmaceutical and biotechnology excellence. These areas raise the question: How does an area become a hub for competing businesses? 1 TEConomy Partners.

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MAY 10, 2023

1 May 2023 Funded by the European Commission from 2019, the Smart Pharmaceutical Manufacturing Project (SPuMoNI) 1 harnesses the potential of state-of-the-art technologies for the pharmaceutical industry. Juan Miguel García-Gómez, Ph.D. Chis, Ph.D. Horacio Gonzalez-Velez, Ph.D. This article discusses the main SPuMoNI accomplishments.

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JANUARY 8, 2023

The use of xAI can help address the algorithmic complexity of AI, which may lead users and subject matter experts as well as stakeholders from QA functions to find it difficult to comprehend the solution’s decisions. Lecture Notes in Computer Science 11700 (2019) Springer, Cham.

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AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. For a synthetic drug, the DS is chemically synthesized in multiple ordered steps from the starting materials using a range of chemicals. Regulatory Landscape for Raw Materials: CMC Considerations.

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MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Brown Megan E. McMahon Timothy J.N. The authors propose using Module 2.3 The authors propose using Module 2.3

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MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Brown Megan E. McMahon Timothy J.N. The authors propose using Module 2.3 The authors propose using Module 2.3

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AUGUST 29, 2022

For products with a large global footprint, the time required from submission to global approval and implementation of a single change can take years while the change obtains approval across all the relevant regulatory agencies. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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MARCH 7, 2023

Sustainability: Corporate Ambition, Governance, & Accelerated Delivery Trudy Patterson Tue, 03/07/2023 - 09:14 Features March / April 2023 Sustainability: Corporate Ambition, Governance, & Accelerated Delivery Guy Wingate, PhD Ylva Ek Patricia M. Transforming Our World: The 2030 Agenda for Sustainable Development.” October 2015. Climate Change.

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The Checkup by Singlecare

OCTOBER 18, 2023

Food and Drug Administration (FDA) to treat mental health conditions such as major depressive disorder, panic disorder, obsessive-compulsive disorder (OCD), and binge eating disorder. If you experience any of these, seek medical advice from a healthcare professional and report any uncommon or worsening adverse effects.

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JANUARY 10, 2023

Rapid Filter or Resin Change Strategies for Biomanufacturing Trudy Patterson Tue, 01/10/2023 - 14:05 Technical January / February 2023 Rapid Filter or Resin Change Strategies for Biomanufacturing Amy C. Rhee, MS Tabetha Bonacci, PhD Bradford Stanley Greg Evangelist John Fisher John Armando, MSc, RAC Yuh-Fun Maa, PhD Asif Ladiwala, PhD Christopher J.

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MARCH 15, 2023

In facility design, solutions are derived through science-based analyses of environmental impacts from the materials, processes, services, and architecture. From greener energy sources to a reduction in the type and amount of emissions, we are seeing improvement in this sector’s environmental footprint. 7 An integrative (vs.

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OCTOBER 27, 2022

Cell and gene therapies (C>) have unique needs in manufacturing suites that differ from those for classic product biopharmaceuticals. Facilities must be created with flexibility in mind, able to run multiple products and production types to remain viable. These considerations include processing safety (e.g., Flexible Facilities.

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SEPTEMBER 10, 2023

An Evaluation of Postapproval CMC Change Timelines Trudy Patterson Sun, 09/10/2023 - 11:22 Features September / October 2023 An Evaluation of Postapproval CMC Change Timelines Rob Harris, PhD Meike Vanhooren Kara Follmann, PhD Beth Kendsersky Timothy J.N. Watson, PhD Melinda Imperati S.

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Pharmaceutical Technology

MAY 30, 2023

The Menarini Group today has announced exploratory results from its EMERALD clinical study that suggest its recently approved oral selective estrogen receptor downregulator (SERD) Orserdu (elacestrant) could have potential in a wider group of patients with metastatic breast cancer. months, versus 1.87

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Pharmaceutical Technology

FEBRUARY 23, 2023

Many compounds present sub-optimal pharmacokinetic (PK) data (either predicted from in-vitro and pre-clinical data or measured in the clinic), such as poor exposure (leading to high doses), large variability, short half-life requiring more than once-a-day dosing, or C max -related adverse events (AEs).

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Pharma Marketing Network

JUNE 8, 2020

If you could, can you summarize your thoughts on how you feel the opioid crisis came about, and what actions our listeners can take to help break this cycle and avoid another crisis coming down the pike. This is Don Langsdorf with the Pharma Marketing Network pleased to welcome today Dave Chase, co-founder of the Health Rosetta.

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