505(b)(2): It’s A Different Animal
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Technical / white paper
White Paper: Is My Method Still Valid? - SGS
26-Mar-2013 -
The goal of method validation is to provide proof that data from each individual sample is indicative of the actual batch content with little deviation. This paper outlines the importance of validation as well as the official requirements, including characteristics...
Technical / white paper
ePathology Improves Data Accuracy & Study Productivity! – Amicus Study Confirms - Aperio
20-Mar-2013 -
With current glass slide methods, sharing and scoring slides within a study from one pathologist to another at a different organization or site, meant that slides had to be packed, shipped and tracked. Often the reading pathologist was required to...
Technical / white paper
Best Practices for Achieving and Maintaining Aseptic Conditions During Sterility Testing - SGS
03-Dec-2012 -
Sterility testing is required for companies producing pharmaceutical products and consistent and meticulous testing is essential to obtain results that accurately represent the sterility status of a batch. Download this article for the best practices
Insight guide
Analytical Method Development and Validation — A CDMO Perspective - DPT Labs
28-Nov-2012 -
Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical development companies including developing a scaleable, marketable formulation, ensuring safety and efficacy of the drug product and receiving approval of the drug...
Technical / white paper
INFLUENZA TREATMENT CLINICAL TRIALS: CLINICAL CASE STUDIES - SGS
19-Nov-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.
Case study
Extractables & Leachables Risk Assessment - SGS
22-Oct-2012 -
An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production process of a European manufacturing plant for 40 finished products, resulting in a global testing plan.
Technical / white paper
New Early Phase Concepts: Practical Implementation - SGS
03-Sep-2012 -
There is an urgent need to use innovative techniques in early development. This paper will discuss several case studies in which new clinical trial methods were employed during the early phase clinical development of therapeutic compounds.
On-Demand Supplier Webinar
Targeted Product Development: Personalized Medicine versus Orphan Product Development - Rho
31-Jul-2012 -
The development of therapeutics for personalized medicine leverages many of the advantages of the legislation conferred upon orphan products. New products must be positioned intelligently to take advantage of this legislation. Join David Shoemaker, Ph.D. as he discusses the benefits...
Technical / white paper
Vaccine-Based Clinical Trials - SGS
09-Jul-2012 -
Download this paper to read two case studies which illustrate strategies for planning and implementing a vaccine-based infectious disease clinical trial versus a therapeutic-based trial.
Technical / white paper
Sample Prep Proposed USP<233> Elemental Impurities - SGS
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
How to Approach Identification of Anomalous Peaks - SGS
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
New Challenges in Early Clinical Development - SGS
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...
Technical / white paper
Glycosylation of Proteins: Structure & Analysis - SGS
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...
Technical / white paper
Improving Signal Detection in Drug Safety - SGS
07-Nov-2011 -
Early identification and management of emerging drug safety issues are a major concern of industry stakeholders. Electronic capture systems for AE reporting now allow for faster accumulation of data and the ability to perform complex analysis.
Technical / white paper
White Paper: Vaccine-Based Clinical Trials - SGS
26-Sep-2011 -
Download this paper to read two case studies which illustrate strategies for planning and implanting a vaccine-based infectious disease clinical trial versus a therapeutic-based trial.
Technical / white paper
Protein & Glycoprotein Characterization by MS - SGS
30-May-2011 -
This paper gives the essential background to understanding biopharmaceutical characterization by mass spectrometry and its importance in accelerating the processes leading to the approval of new drug products, including mAb’s, hormones, cytokines
On-Demand Supplier Webinar
Are you getting the right bioavailability and bioequivalence data for inhalation products you’re developing? - DPT
15-May-2011 -
Consider the risk to your development program of not accounting for patient variation in device handling. In this webinar DPT Labs and Proveris Scientific team up to demonstrate how the Ergo system can help you develop the right actuation parameters...
Technical / white paper
The 10 Essential Don’ts for Manufacturers to combat Main Street’s ‘New Normal’ and win - CDC Software
10-Sep-2010 -
Many factories are currently engaged in many cost reduction initiatives that are stumbling or have dramatically slowed down. In many cases they continue because received wisdom supposes that they must deliver a benefit otherwise we would not be doing them....
Technical / white paper
Exploristics supports the Design and Validation of Clinical Rating Scales, Patient Reported Outcomes, Composite Endpoints and Quality of Life Data - Exploristics
25-Aug-2010 -
Quality of Life, Patient Reported Outcomes, Composite Endpoints and Clinical Ratings Scales have important applications in clinical research and practice. These instruments provide vital measures of the effectiveness of treatment as well as the general well-being and physical and psychological...
Technical / white paper
Beyond Plant Visibility to Business Improvement - CDC Software
17-Aug-2010 -
Increasing evidence is pointing to the realization that many plant-wide intelligence initiatives do not lead to the dramatic improvements that the business wants and needs. This Cambashi Analyst White Paper discusses five major factors that producers must incorporate into their...
