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Hybrid FSP/FSO Solutions Enable Flexibility and Agility to Keep Biotech Trials On Time and On Budget

PPD

are outsourced to a contract research organization (CRO) partner. The PPD™ clinical research business of Thermo Fisher Scientific helps clients create all manner of flexible outsourcing solutions, many of which are detailed in our recent white paper, “Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships.”

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Demystifying the ICH M10 Bioanalytical Method Validation Guidelines

Conversations in Drug Development Trends

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

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Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ for (Bio)Pharmaceuticals Safety Assessment

Alta Sciences

Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ for (Bio)Pharmaceuticals Safety Assessment tchichekian Tue, 07/23/2024 - 12:14 Publication White paper_Sinclair Nanopig Data_v3.pdf pdf Tags Preclinical Research URL [link] Category White Paper Weight 5

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Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Conversations in Drug Development Trends

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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Informed Design of Bioanalytical PCR Assay Testing Parameters

PPD

Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance. DOWNLOAD OUR WHITE PAPER Learn more about how PPD® Laboratory services can enhance your CGT projects. The post Informed Design of Bioanalytical PCR Assay Testing Parameters appeared first on PPD Inc.

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Analysis Life Sciences Thank You CDER’s Office of Pharmaceutical Quality to reorganize, citing need to address ‘pain points’

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC | NOV 9, 2023 6:35 PM CST Background on CDER’s Office of Pharmaceutical Quality (OPQ) CDER’s Office of Pharmaceutical Quality became operational in January 2015, making it a still relatively recent addition to the agency. Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

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New Janssen Initiative Aims to Advance Equitable Care and Address Hidden Threat of Amputation Related to Peripheral Artery Disease (PAD)

The Pharma Data

™, Janssen seeks to elevate PAD research, collaboration, education and screening for communities placed at increased risk of cardiovascular disease. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the launch of Save Legs. Research to Break Down Barriers to PAD Screening and Increase Equitable Care.

Disease 52