Whitepapers
To provide readers with rich information and knowledge, this section of the website includes white papers that address current issues, technology, research, etc, covering every aspect of the pharmaceutical industry.
Smoothing the Path to Drug Development with Accurate Clinical Data
Drug development is a long costly and complex process At its core lies a critical question How does a drug affect the bodyand how does the body respond The answers are derived from wellstructured pharmacokinetic PK pharmacodynamic PD
In Vivo Testing of Nasal Dosage Forms
Interest in developing nasal dosage forms has increased significantly in the last two years with a number of high profile products receiving FDA approval Indeed the rapid systemic uptake the ease of dosing have made this an attractive dosing option for a wide range of drugs
Advancements in Drug Safety and Pharmacovigilance Using AI and Generative AI (LLMs)
The white paper explores trends in adverse drug event reporting from the FDAs Adverse Event Reporting System FAERS over the past decade showing a marked increase in the volume and seriousness of reports Between and FAERS recorded million total reports including million serious reports
Identifying the Root Cause of "Slow Growth" in CAR-T Manufacturing with a Data-Driven Approach
Chimeric Antigen Receptor Tcell CART therapy represents a breakthrough in cancer treatment offering a personalized approach by harnessing a patients immune cells to target and eliminate cancerous cells However the manufacturing process behind these therapies is intricate timeconsuming and often hindered by slow growth in cell expansion phases
Spray Drying Biologics: An Alternative to Freeze Drying
Drug products containing active biological ingredients form one of the most important and fastestgrowing sectors of the pharmaceutical industry These biologics include a wide range of large complex molecules including protein
The New Normal: How COVID-19 Became the Catalyst for Change
When COVID disrupted life sciences solutions were needed in realtime As the pandemic grew so did the need to innovate Workers met the challenges They completed tasks fulfilled inspections and remained vigilant in fulfilling regulatory requirements This paper presents findings from a roundtable hosted by PharmaLex
Driving value creation through medical affairs in China
After more than three decades of fast economic growth China has entered the new normal stage marked by a moderate and stable domestic GDP growth rate Healthcare has been elevated to a national level agenda by the current leadership with the releasing of China Health
Launching Global Clinical Trials—best Practices For Efficient And Cost-effective Translations: A Lionsbridge White Paper
Summary The target market for conducting global clinical trials has changed significantly moving beyond pharmaceutical early adopters to the mainstream marketplace This shift has placed a heightened focus on the language challenges and complexity of running a global clinical trial More and more companies are moving toward
Pharmacopeia Requirements For Pure Steam And Final Rinse Verification Of Cip: A METTLER TOLEDO White Paper
Summary Validation of Pure Steam and the verification of the final aqueous rinse in a CIP process are defined by regulatory standards which change periodically and challenge system designers and owners to know the latest requirements This white paper contains an overview of current pharmacopeia requirements which will assist in the design and monitoring of comp
Effective Randomization Is Key To The Success Of A Trial: A Cenduit White Paper
Summary Randomized doubleblind clinical trials are the gold standard for adequate and wellcontrolled studies in modern times However prior to the late s randomization and blinding were not used in medicine and as result bias was common For example treatment bias was often observed as physicians would treat sicker patients with known controls while
