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04.05.21 -- Bayer Overhauls Its Clinical Trial Planning Process

04.05.21 -- Bayer Overhauls Its Clinical Trial Planning Process
clinicalleader.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from clinicalleader.com Daily Mail and Mail on Sunday newspapers.

Uday Pathapati , Katy Preciado , Gavin Morgan , Jessica Schell , Aliciac Staley , Philips Respironics , Majaz Hussain , Jessica Settimi , Tiago Mateus , Alnylam Pharmaceuticals , Clinical Services , World Interrogation Network , Watson Health , White Paper Veeva Systems Inc , Research Development Solutions , Dassault Syst , Thermo Fisher , Veeva Systems , Ciox Real World , Big Data , Analytics Real World Interrogation Network , கட்டி பிரெசியாதோ , கவின் மோர்கன் , ஜெசிகா ஸ்கெல் , அஜாஸ் ஹுசைன் , தியகோ மத்ேஉச் ,

04.01.21 -- Auditing Electronic Batch Records For cGMP Status

04.01.21 Auditing Electronic Batch Records For cGMP Status

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Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
This article presents some advice for auditing electronic batch records to assess their cGMP status. This is useful in the qualification stage and essential once the electronic record system is in operation.
Industry Insights
Article ....

Comunidad Autonoma De Cataluna , Paul Magreta , Majaz Hussain , Brian Stephens , Mukta Acharya , Jessica Settimi , Quadro Comil , Case Study Seeq Corporation , Case Study Flow Sciences Inc , Equipment Company , Article Promega Corporation , Application Note Silverson Machines Inc , Samira Shore , Thermo Fisher , John Barley , Grifols Recombinant Protein , David Winger , Federal Equipment , Maurizio Della Pietra , Particle Measuring , Brandy Sargent , Lonza Pharma , Silverson Machines , Flow Sciences , காமுனிடட தன்னாட்சி டி கடலுள் , அஜாஸ் ஹுசைன் ,

Navigating the Adoption of Continuous Pharma Manufacturing Amid Unprecedented Global Challenges

Navigating The Adoption Of Continuous Pharma Manufacturing Amid Unprecedented Global Challenges
Source: Thermo Fisher Scientific
By Ajaz Hussain, Independent Consultant, and Jessica Settimi, Senior Director, Continuous Manufacturing, Thermo Fisher Scientific
In addition to the devastating impact the COVID-19 global pandemic has had on public health, the economy, and the overall quality of our day-to-day lives, it has also exposed significant risks in today’s pharmaceutical supply chain. Improvements in speed to market and quality assurance, among other factors, need to be made to ensure not only the timely delivery of safe and efficacious drugs but also the stability necessary to manage future risks and disruptions. ....

Majaz Hussain , Jessica Settimi , Independent Consultant , Senior Director , Continuous Manufacturing , Thermo Fisher , அஜாஸ் ஹுசைன் , சுயாதீனமான ஆலோசகர் , மூத்தவர் இயக்குனர் , தொடர்ச்சியான உற்பத்தி , தெர்மோ மீனவர் ,

Navigating the Adoption of Continuous Pharma Manufacturing Amid Unprecedented Global Challenges

Navigating The Adoption Of Continuous Pharma Manufacturing Amid Unprecedented Global Challenges
Source: Thermo Fisher Scientific
By Ajaz Hussain, Independent Consultant, and Jessica Settimi, Senior Director, Continuous Manufacturing, Thermo Fisher Scientific
In addition to the devastating impact the COVID-19 global pandemic has had on public health, the economy, and the overall quality of our day-to-day lives, it has also exposed significant risks in today’s pharmaceutical supply chain. Improvements in speed to market and quality assurance, among other factors, need to be made to ensure not only the timely delivery of safe and efficacious drugs but also the stability necessary to manage future risks and disruptions. ....

Majaz Hussain , Jessica Settimi , Independent Consultant , Senior Director , Continuous Manufacturing , Thermo Fisher , அஜாஸ் ஹுசைன் , சுயாதீனமான ஆலோசகர் , மூத்தவர் இயக்குனர் , தொடர்ச்சியான உற்பத்தி , தெர்மோ மீனவர் ,

Product Development For An Oral Solid Dosage Using Continuous Manufacturing

Product Development For An Oral Solid Dosage Using Continuous Manufacturing
Source: Thermo Fisher Scientific
By Kiernan LaMarche and Jessica Settimi, Thermo Fisher
When bringing a new drug to market, product development is typically aligned with the clinical trial schedule; therefore, as the patient pool grows, so does the supply of drugs needed for the study. Phase I calls for a small trial formulation using the easiest and least expensive manufacturing methods for just getting the drug to the patient. Once you move into Phase II, a prototype batch process is often most cost effective, especially since most drug candidates do not make it past this stage. ....

Jessica Settimi , Kiernan Lamarche , Thermo Fisher , கியர்நெந் லமர்ச்ெ , தெர்மோ மீனவர் ,