505(b)(2): It’s A Different Animal
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Live Supplier Webinar
Antibody Drug Conjugate Development and Manufacture - Piramal
03-May-2013 -
With the recent approvals of brentuximab vedotin (Adcetris) and ado-trastuzumab emtansine (Kadcyla,T-DM1), antibody–drug conjugates (ADCs)are a rapidly growing area in oncology with great potential. Development and manufacture of ADCs can be a challenge with the requirement to handle both biologics...
On-Demand Supplier Webinar
Supply Chain Issues and Trends in Asia - Marken
02-May-2013 -
Import/export of biological samples from China
China: Large Pharma Reverse Logistics
A Common Issue: Destruction of Drug in Taiwan
J-GMP: How is GMP different in Japan?
Korea: Biosimilars Hotbed
India: Will Regulations Change to Allow Quicker Study Approval in 2013?
Case study
A risk assessment framework for donor and recipient companies to jointly analyze and document the technical and business risks associated with the technical transfer of pharmaceutical product - Alkermes
22-Apr-2013 -
Every technical (tech) transfer is different, with companies taking different paths toward reaching their goal. Each one presents a unique set of challenges. These challenges are most often technical, but at times they may also be business related. However all...
Technical / white paper
Clinical Trial Logistics in Africa: Ensuring Quality, Compliance and Control within the Pharmaceutical Supply Chain - World Courier
01-Jan-2013 -
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,...
Technical / white paper
New European Offices, Thermal Packaging Alternatives Accommodate Specialized Needs of World Courier Biopharm Customers - World Courier
11-Feb-2013 -
World Courier’s newly-expanded international network − now numbering 152 office locations in 52 countries − brings expertise, personnel and infrastructure closer to key customers in Switzerland and Austria with the recent opening of offices in Basel and Innsbruck.At the same...
Video
The Best of Both Worlds: Swiss Quality, Made in China - Lonza
05-Feb-2013 -
Lonza brings you the best of both worlds with Swiss quality manufacturing of APIs available at our FDA approved facility in Nansha, China. From backward integration to tailored production concepts for efficient manufacturing, Lonza offers sustainable solutions for regionally important...
Case study
Blinding Techniques for Inhaler Devices - Development of a Novel Blinding Methodology for a Market Leading DPI - Almac Group
21-Jan-2013 -
Blinding inhalers for use in clinical studies is a challenging and specialised area of clinical trial supplies. In this case study, Almac provide a real life overview of their unique inhaler blinding services which have been successfully developed and validated,...
Case study
Alkermes successful approach to commercial-scale, final dosage manufacture of drug product containing highly potent API for a global pharmaceutical company. - Alkermes
18-Dec-2012 -
As part of Alkermes plc, Alkermes Contract Pharma Services, provides solid oral dosage product development, scale–up and manufacturing services as well as sterile fill finish capabilities to the global pharmaceutical market. This case study demonstrates how a commercial manufacturing partnership...
On-Demand Supplier Webinar
Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality - Rho
15-Oct-2012 -
The Industry’s changing approach to clinical data monitoring requires the tools and team structure to effectively plan and execute risk-based monitoring. Join Lynn King and Rob Woolson as they discuss multi-disciplinary approaches to implementing alternative monitoring plans and specialized tools...
Data sheet
Connecting Perfectly At Every Stage - Parexel
30-Jul-2012 -
We believe in one bond that's more important than all others. Download our brochure to see how PAREXEL can help to optimize your product value.
Technical / white paper
The new product development reality - Parexel
25-Jun-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
Finding the right contract manufacturer - Vetter Pharma International GmbH
06-Jun-2012 -
Contract manufacturing became popular in many industries during the 1990s as a way to counter rising costs and to reinvestment. The pharmaceutical industry has been slow to adopt this practice because of its absolute need for secrecy.However, with fewer blockbuster...
On-Demand Supplier Webinar
Stop the pain: Tips for increasing patient retention and decreasing missing data in analgesia clinical trials - Rho
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
Risk-Reducing Solutions for Global Study Logistics - World Courier
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.
On-Demand Supplier Webinar
Flow Cytometry Analysis of Clinical Trial Samples - Millipore
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...
On-Demand Supplier Webinar
Next generation bioanalysis using the Gyrolab® platform. Developing biomarker and immunogenicity assays for clinical studies. - Millipore
25-Sep-2011 -
High throughput screening of antibody pairs to determine best binding characteristics, and their selection for development of immunoassays. Identification of instrument considerations and representative data of sensitive cytokine assays with large dynamic ranges that can be run with high throughput...
Video
Biomarker Services at Pacific Biomarkers, Inc. - PBI
13-Apr-2011 -
Dr. Tim Carlson, PhD, Director of Laboratory Services at PBI, discusses biomarkers and PBI's future in this emerging field.
On-Demand Supplier Webinar
Biomarkers of Metabolic Syndrome in Clinical Trials - PBI
11-Feb-2011 -
PBI scientists will discuss latest developments in biomarkers for metabolic syndrome. Topics: 1) Pre-analytical and analytical concerns regarding gut and incretin hormones, 2) Dysfunctional HDL biomarkers in metabolic syndrome, and 3) Kidney Injury Markers and their usefulness in diabetic nephropathy....
Technical / white paper
Method Development and Validation of Caffeine and Paraxanthine in Human Plasma - BASi
18-Oct-2010 -
BASi’s expanded European facility provides contract research services — preclinical, toxicology, bioanalytical, method development and pharmaceutical analysis — as well as, specialized instrumentation for electrochemistry and in vivo sampling products. BASi focuses on developing innovative services and instrumentation that increases...
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...
