Data sheet
23-May-2012 -
At a time when supply chain management has become increasingly complex, managing the unique challenges of the controlled substance supply chain can seem daunting for companies lacking in‐house capabilities and resources. Effective management of the controlled substance supply chain and...
Product brochure
16-May-2012 -
Almac’s aXcess™, coupled with clinical packaging and distribution bundle, bridges the gap between paperless and web-based drug supply management. aXcess™ is configurable, can be set up very quickly, and is cost effective. The system includes features such as language capabilities and...
Technical / white paper
01-May-2012 -
WORLD COURIER is the market leader in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens in Africa and worldwide. It offers a fully-integrated GxP-compliant pharmaceutical supply chain system, strong knowledge of the local regulatory environment,...
On-Demand Supplier Webinar
25-Apr-2012 -
The Prescription Drug and User Fee Act (PDUFA) IV will expire in September 2012. A new version of this legislation, PDUFA V, is expected in the coming months and may have implications for your regulatory strategy and development program. Join...
Technical / white paper
23-Apr-2012 -
While winning FDA or other regulatory approval is a formidable hurdle, it is no longer the end game when it comes to defining if the development of a product is truly successful. In today's health care reality, the new finish...
Technical / white paper
17-Apr-2012 -
Applying LEAN techniques can result in improved productivity, workflow efficiency and cost savings. The Quality Control Laboratory at Baxter’s contract manufacturing facility in Halle/Westfalen, Germany, has been applying LEAN techniques since 2007 with the goal of reducing release lead times....
Technical / white paper
09-Apr-2012 -
Management of medication delivery through intravenous (IV) administration is a complex and challenging task for pharmacists. The information provided reflects research conducted assessing medication delivery practices and preferences.
Technical / white paper
02-Apr-2012 -
Development of influenza vaccines is critical; but, there is also a need for new influenza treatments. This article presents an overview of challenges faced when conducting an influenza treatment study based on two recently managed clinical trials.
Technical / white paper
27-Feb-2012 -
Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how solubility of the test article may not be the primary factor when choosing a sample preparation method.
Technical / white paper
22-Feb-2012 -
The sudden appearance of an unknown peak during an HPLC analysis of a pharmaceutical product can be a critical finding causing delays and requiring considerable resources to resolve. The unknown peak can be caused by many things ranging from simple...
Technical / white paper
20-Feb-2012 -
To optimize lyophilization cycle times and improve stability for complex injectables, Baxter’s BioPharma Solutions contract manufacturing business established the Lyophilization Center of Excellence, an industry-leading resource for development of high-quality freeze drying.
Data sheet
15-Feb-2012 -
The distribution of clinical supplies globally can be a challenge for any trial, especially with many new emerging markets. Almac Clinical Services provides contract services to the clinical trial supply industry serving both Pharmaceutical and Biotech companies worldwide and has...
Data sheet
25-Jan-2012 -
In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure...
Technical / white paper
24-Jan-2012 -
With many new challenges in early clinical development there is pressure to change how early phase clinical trials are conducted where the final goal is to shorten the time to go-no-go decisions and decrease cost. It is increasingly important to...
On-Demand Supplier Webinar
23-Jan-2012 -
Analgesic clinical trials often fail, even when we know the drugs work. Join Lynn King and Karen Kesler as they share real-world solutions for trial design, execution, and analysis that will increase patient retention, minimize missing data, and help you...
Technical / white paper
01-Jan-2012 -
Dr. Rüdiger Lomb, Global Director, Quality & Technical Compliance for World Courier, discusses the merits of using a fully-integrated closed-loop supply chain system to improve compliancy and reduce risk in keeping with current ICH requirements.
Technical / white paper
06-Dec-2011 -
Glycosylation is one of the most widely observed, and structurally diverse, forms of post-translational modification of proteins and glycans have been shown to have a range of specific biological roles. Mass spectrometry-based techniques provide an extremely powerful tool for glycan...
On-Demand Supplier Webinar
01-Dec-2011 -
Flow cytometry is a versatile, multiparameter technique with many applications including pharmacodynamic analysis for clinical studies.We invite you to attend our webinar where strategies will be outlined to prevent anomalous and misleading reporting.Flow cytometry is a versatile, multiparameter technique with...
Technical / white paper
28-Nov-2011 -
In order to achieve controlled production of a desired polymorphic form it is essential to primarily understand the product and be intimately familiar with the process. Furthermore, scaling up the crystallization process requires an expert team of experienced scientists working...
Case study
17-Nov-2011 -
Alkermes' Contract Pharma Services provides solid dosage form product development, formulation solutions and manufacturing services for the pharmaceutical market. With a long and successful history in the development and manufacture of pharmaceutical dosage forms for pharmaceutical markets worldwide, previously as...
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