Content provided by Altasciences | 28-Sep-2023
| White Paper
In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...
Content provided by Lonza Capsules & Health Ingredients | 27-Sep-2023
| White Paper
International Journal of Pharmceutics: In Vitro: The dissolution characteristics of five capsules (Next Generation Enteric [NGE], Vcaps® Enteric [VCE],...
Content provided by Lonza Capsules & Health Ingredients | 01-Sep-2023
| White Paper
Invivo: Many orally dosed APIs are bioavailable only when formulated as an enteric dosage form to protect them from the harsh environment of the stomach....
Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 14-Aug-2023
| White Paper
Setting the groundwork for successful scale-up is essential for getting a therapeutic to market quickly and efficiently, but navigating the unknowns associated...
Content provided by Bora Pharmaceuticals | 10-Aug-2023
| White Paper
Successfully manufacturing a drug product requires people, proper equipment, and materials. It’s the classic three-legged stool analogy. Even with well-trained...
Content provided by Formedix | 01-Aug-2023
| White Paper
When it comes to efficient clinical study build, content is king. Most importantly: metadata content. In this blog, we explore the role of metadata in...
Content provided by Lonza Small Molecules | 11-Jul-2023
| Insight Guide
With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles...
Content provided by Lonza Small Molecules | 20-Jun-2023
| Insight Guide
Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...
Content provided by Formedix | 19-Jun-2023
| White Paper
In April 2023 at the CDISC Europe Interchange, we launched Formedix CORE, the first free-to-use, downloadable application encompassing the CDISC Open Rules...
Content provided by Bora Pharmaceuticals | 13-Jun-2023
| White Paper
The biopharma landscape is forever changing, and with it, a demand from both patients and investors for the rapid development and progression of drug products...
Content provided by Formedix | 12-May-2023
| White Paper
What are SDTM supplemental qualifiers? In short, these are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard....
Content provided by Altasciences | 02-May-2023
| White Paper
As a leading partner in central nervous system (CNS) drug development, Altasciences’ in-house preclinical, clinical, bioanalytical, and manufacturing teams...
Content provided by Formedix | 17-Apr-2023
| White Paper
Companies often have to conduct multiple clinical trials at the same time, which means they've got to be efficient, and compliant with industry regulations....
Content provided by Elligo Health Research® | 13-Apr-2023
| Insight Guide
You want your clinical research practice to be a success for your business and your patients, but how can you tell if it’s in trouble? Read this article...
Content provided by Florence Healthcare | 01-Apr-2023
| Insight Guide
Shifting to eRegulatory and eSource workflows is a requirement for clinical trial sites to continue to scale and grow their studies. This guide is designed...
Content provided by Lonza Small Molecules | 28-Mar-2023
| White Paper
A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways...
Content provided by Elligo Health Research® | 23-Mar-2023
| Insight Guide
On April 15, 2022, the U.S. Food and Drug Administration issued a new draft guidance to clinical research sponsors on creating a plan to enroll more participants...
Content provided by Indena | 15-Mar-2023
| White Paper
Indena’s Custom Development & Manufacturing Organization services offer a full range of manufacturing capabilities for pharmaceutical ingredients including...
Content provided by Catalent | 08-Mar-2023
| Infographic
With clinical study activity increasing across the Asia-Pacific region, it is important for sponsors—both in APAC and globally—to understand the broader...
Content provided by Florence Healthcare | 08-Mar-2023
| Insight Guide
89% of research sponsors currently use and expect to continue the use of decentralized technologies and methods, according to our state of the industry...
Content provided by Florence Healthcare | 01-Mar-2023
| Insight Guide
Discover the trends shaping clinical trial technology in 2023, from Site Enablement to eISFs, integrations, and site-sponsor collaboration. This report...
Content provided by Piramal Pharma Solutions | 16-Feb-2023
| White Paper
Winning approval for a new molecular entity is just a staging post on the journey of a drug. To maximize the benefits of a therapy, drugmakers need to...
Content provided by Formedix | 13-Feb-2023
| White Paper
The use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND...
Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 09-Feb-2023
| White Paper
Supply chain issues have real, quantifiable impacts on biomanufacturers. However, the right support can make a cGMP supply chain operate seamlessly. Thermo...
Content provided by Formedix | 16-Jan-2023
| White Paper
This article covers the many ways a clinical metadata repository helps with data quality in the clinical trial process, and how it ultimately helps to...
Content provided by PPD - Decentralized Clinical Trials | 12-Jan-2023
| White Paper
Prioritizing greater patient-centricity and creating an opportunity to reach unprecedented patient groups, decentralized and hybrid clinical trials are...
Content provided by Formedix | 14-Dec-2022
| White Paper
Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your...
Content provided by PPD - Decentralized Clinical Trials | 13-Dec-2022
| White Paper
As a CRO, PPD (part of Thermo Fisher) can help guide the future of clinical research. Its depth of experience with decentralized clinical trials (DCTs)...
Content provided by Piramal Pharma Solutions | 15-Nov-2022
| White Paper
Operational Excellence (OE) is a key element of organizational leadership and intelligence. For a CDMO operating in the pharmaceutical industry, OE focuses...
Content provided by Formedix | 09-Nov-2022
| White Paper
This article gives an overview of SDTM, ADaM, SEND and ARM, and discusses how these CDISC standards fit in with the wider clinical trial process, and how...
Content provided by JRS PHARMA | 29-Oct-2022
| White Paper
The aim of this study was to investigate the disintegration behavior of croscarmellose sodium (CCS), sodium starch glycolate (SSG) and crospovidone (PVPP).
Content provided by Indena | 25-Oct-2022
| White Paper
Indena is well known in the space of naturally derived molecules, with a know-how developed over its one hundred year history. At the same time, the company...
Content provided by Altasciences | 25-Oct-2022
| White Paper
Bringing new drugs to market, from lead candidate selection through preclinical testing, to clinical proof of concept, is a complex, time-consuming, and...
Content provided by Formedix | 10-Oct-2022
| White Paper
CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical...
Content provided by Altasciences | 04-Oct-2022
| White Paper
Ophthalmic drug development comes with a unique set of challenges that can be mitigated by working with an end-to-end solution provider with regulatory...
Content provided by CellCarta | 08-Aug-2022
| Case Study
Streamline your adoptive cell therapy program with digital PCR. Our team has a unique expertise in digital and quantitative PCR to support you in ensuring...
Content provided by JRS PHARMA | 01-Aug-2022
| Clinical Study
This study aimed to compare the performance of VIVAPHARM® PVP K25, VIVAPHARM® PVP K30, and VIVAPHARM® PVP K90 respectively as wet-granulation binders in...
Content provided by Altasciences | 15-Jul-2022
| White Paper
A first-in-human (FIH) clinical trial is a significant milestone in the development of a potential new drug. A successfully conducted FIH trial provides...
Content provided by Baxter BioPharma Solutions | 13-Jul-2022
| White Paper
The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting...
Content provided by Baxter BioPharma Solutions | 13-Jul-2022
| White Paper
Convenience, product differentiation, and less waste are great reasons for developing a product in a prefilled syringe. Baxter’s whitepaper describes the...
