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Your Guide to the Ultimate Pharmaceutical Product Improvement Tool This whitepaper will review how automating the annual product quality review (APQR) process can help pharmaceutical companies simplify and optimize their product quality review process, to make informed product quality decisions quicker and on a more routine and proactive basis.
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 whitepaper, “Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships.”
WhitePapers / Tech Papers. Chewing gum as a dosage format for pharmaceutical applications in the OTC market stands out as a fast growing, innovative dosage format. Source link.
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.
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 WhitePaper Weight 5
Discover five good manufacturing practices for water monitoring and sanitization for pharmaceutical use. Download Mettler Toledo’s Pharmaceutical Waters whitepaper to discover how to:
Monitor water for injection in real-time.
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Ensure water system control.
Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality. By John W.M.
Download Mettler Toledo’s Pharmaceutical Waters whitepaper to discover how to:
Monitor water for injection in real-time.
Ensure water system control.
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Drive continuous water monitoring in your manufacturing processes.
Learn about new solutions for real-time and thorough monitoring of pharmaceutical water systems to ensure only the highest quality products are delivered to patients. Download Mettler Toledo’s whitepaper for:
Insights on how to meet the demands of ever-stricter water testing regulations head on.
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23, 2020 — In a Society for Healthcare Epidemiology of America whitepaper, published online Oct. ” Several authors disclosed financial ties to the pharmaceutical and health care industries. Professional. SHEA Updates Guidance for Health Care Staff With Hepatitis, HIV. FRIDAY, Oct. Abstract/Full Text.
Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance. DOWNLOAD OUR WHITEPAPER 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.
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 WhitePaper here.]
Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game. Compliance ensures that interactions between pharmaceutical companies and KOLs are transparent, fair, and free from any undue influence.
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 whitepaper, “ First-in-Human Studies: IND or CTA? ”.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the launch of Save Legs. About the Janssen Pharmaceutical Companies of Johnson & Johnson. Change Lives. ™, Janssen seeks to elevate PAD research, collaboration, education and screening for communities placed at increased risk of cardiovascular disease.
For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Access the whitepaper The post Patient-Centric Strategies for Successful Oncology Trials appeared first on PPD. Enable every aspect of your complex oncology trial.
Teva Pharmaceutical Industries Ltd. On behalf of clients, MGA conducts original data analysis, constructs economic models, conducts research, writes whitepapers and expert reports and offers strategic advice. Teva saved the United States $28.8 billion in 2020, $4.2 Source link: [link].
What is the state of pharmaceutical quality in the U.S.? Call it murky A new report published by the FDA’s Office of Pharmaceutical Quality (OPQ) promises a look at the current “State of Pharmaceutical Quality.” Read AgencyIQ’s analysis of FDA’s QMM WhitePaper here.]
While the FSP model is growing in popularity and serves a critical role in pharmaceutical development, getting the most out of this model requires dedicated roles to drive implementation, communications and planning. Read our whitepaper to learn the keys to successfully implementing functional service partnerships.
Agility requires much tighter and more transparent holistic relationships with suppliers and levels of collaboration that have not been consistently achieved in the pharmaceutical industry, largely because of the constraints in sharing accurate data.”.
Our new directors are well-recognized for their leadership and accomplishments in the biopharmaceutical, biotechnology and pharmaceutical industries, as well as in public capital markets and corporate governance.” Russell served as a director of Endocyte, a Nasdaq-listed public company acquired by Novartis, and AMAG Pharmaceuticals.
… Alcami’s scientists have substantial experience designing and executing food studies that comply with the highest quality standards, which have expedited formulation selection and regulatory approval for a variety of pharmaceutical dosage forms.
Why are Food Studies needed?
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Biopharmaceutical products represent up to 20 percent of the total pharmaceutical market and are growing at a rate of nearly eight percent annually.
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The analysis of metals in pharmaceutical actives (API), raw material, and drug products has changed as well.
Today’s technology has not only changed the way we receive information, but has continually adapted and progressed how we acquire information. ICP-MS/OES has emerged as a critical analytical platform for this analysis.
The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs).
How the flex hub model saves one developer time and money As an example of the value that our flex hub model brings to biotech and pharmaceutical developers, here is a brief look at one long-term partnership in place since 2013. Ready to implement an FSP engagement as the ideal solution for all your lifecycle maintenance requirements?
Download Pharma IQ ’s report in collaboration with Dotmatics and BioBright to explore why pharmaceutical data integrity and data security are more important than ever in the life sciences industry.
Learn how to improve your data integrity and data security through automation.
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Fermentation is used in the production of renewable feedstocks for food products and ingredients, beverages, pharmaceutical compounds, nutraceuticals, through to fine and bulk chemicals. The Kluyver Center applies microbial genomics to improve the performance of microorganisms in industrial fermentation processes.
attention both from the public and the pharmaceutical industry, it is important to recognize concurrent. The lab’s goal is the. use and development of proteomic methods to. study RNA virus replication and virus-host interactions and in particular the use of single-cell proteomics to aid in this research. As the race for an. therapeutics.
As other health authorities started to require data standards, some, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) decided to opt for CDISC for regulatory submissions.
Media coverage regarding the nomination has been largely focused on concerns expressed by some about Dr. Califf’s past work with pharmaceutical companies in clinical research. The reasoning is again based on Dr. Califf’s association with the pharmaceutical industry – an objection that seems less sure-footed this time around.
is identified as “Improving Supply Chains for Critical Drugs,” and states: “ In 5 years, deploy broad synthetic biology and biomanufacturing capabilities to produce at least 25% of all active pharmaceutical ingredients (APIs) for small molecule drugs ” (emphasis added). generic pharmaceutical industry, resulting in low profit-margins.
WhitePaper: Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ Discover how the Sinclair Nanopig™ is transforming nonclinical safety assessments. Read the whitepaper. Watch it now.
However, in the modern biotech and pharmaceutical industry, a PV RI team needs to do more than just monitor ever-changing regulations. Given the multinational nature of many biotech and pharmaceutical companies, conducting business in multiple countries with multiple vendors is not uncommon.
It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “whitepaper” for the Product Liability Advisory Council on the same subject. Medicis Pharmaceutical Corp. , vs. Ortho-McNeil-Janssen Pharmaceuticals , 2013 WL 2917651 (Pa. Paddock Pool Construction Co. , Accord Kreves v.
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