505(b)(2): It’s A Different Animal
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Data sheet
505(b)(2): It’s A Different Animal - Camargo
13-May-2013 -
505(b)(2) is more than just a regulatory pathway, it is a distinctly different animal — a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. Find out if 505(b)(2)...
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...
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
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
What Makes 505(b)(2) Different? - Camargo
19-Mar-2013 -
When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...
Technical / white paper
Identifying the Product - Camargo
06-Feb-2013 -
When it comes to developing a compound, the 505(b)(2) pathway can make changes to reference products for greater profit potential and lower risk. Camargo Pharmaceutical Services offers a clear process from concept through commercialization to identify products with documented market differentiation:
Selection...
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
Identifying a Differentiated Product – 505(b)(2) - Camargo
08-Oct-2012 -
With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential and lower risk. Camargo offers a clear process to identify products that have documented market differentiation.
Technical / white paper
Identifying the Product - Camargo
26-Sep-2012 -
With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential and lower risk. Camargo Pharmaceutical Services offers a clear process to identify products that have documented market differentiation:
Selection criteria
Identify, assess and...
Data sheet
505(b)(2): Fast and Cost-Effective Drug Approval - Camargo
10-Sep-2012 -
Looking to identify a new product for development or improve an existing compound? For lower risk, reduced cost and faster speed to market, Camargo Pharmaceutical Services is your go-to expert in the 505(b)(2) pathway. Find out if 505(b)(2) is for...
Technical / white paper
Utility of FDG PET in Drug Development - Molecular Imaging Inc.
20-Aug-2012 -
Imaging metabolism with FDG PET offers reliable and clinically translatable biomarkers for evaluation of candidate compounds.
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...
Data sheet
505(b)(2): Fast and Cost-Effective Drug Approval - Camargo
20-Jun-2012 -
Looking to embark on a 505(b)(2) product approval?More products than ever are approved via the 505(b)(2) pathway — a fast and cost-effective route for drug approval. With global reach across 26 countries, Camargo Pharmaceutical Services executes 505(b)(2) drug development programs...
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...
Data sheet
505(b)(2): Fast and Cost-Effective Drug Approval - Camargo
28-May-2012 -
As a fast and cost-effective route for drug approval, more products than ever are approved via the 505(b)(2) pathway. Camargo Pharmaceutical Services is your go-to expert for 505(b)(2) approvals that provide product differentiation and a period of market exclusivity.
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...
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...
