505(b)(2): It’s A Different Animal
Camargo
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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)...
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...
On-Demand Supplier Webinar
Industry Snapshot: Clinical Trial Trends Outline Complexity for Supply Chain - Marken
25-Mar-2013 -
2013 Industry trends driving the scientific, logistical and regulatory complexity of supply chain industry
Implement clinical development methodologies for quality, relationships, and performance
Strategies to optimize drug development to reduce global trial time and costs
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...
Research study
Vcaps® Plus capsules: The next generation HPMC capsule for optimum formulation of Pharmaceutical Dosage forms - Capsugel
28-Feb-2013 -
Traditionally, HPMC capsules have been formulated with secondary gelling agents and ionic gel promoters, which may lead to unwanted issues during the product development.Vcaps® Plus HPMC capsules are made through a proprietary manufacturing process that eliminates the need for gelling...
On-Demand Supplier Webinar
Optimizing your Strategy and Budget for Clinical Trial Supply Distribution - Marken
20-Feb-2013 -
How to determine if a depot or direct to site shipments are more efficient
Calculation based on a case study
How to avoid delays and assure that your shipments arrives without delays and excursions
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...
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,...
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.
Technical / white paper
Lyophilized Pharmaceuticals: A Design Space Approach - Baxter
29-Oct-2012 -
This presentation by Steven Nail, PhD and principal Scientist for Baxter BioPharma Solutions, discusses development of design spaces for lyophilized pharmaceutical products in the context of the Quality by Design regulatory paradigm.
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.
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
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
Lyophilized Pharmaceuticals: A Design Space Approach to Formulation and Process Development - Baxter
09-Aug-2012 -
This webinar will discuss development of design spaces for lyophilized pharmaceutical products in the context of the Quality by Design regulatory paradigm. Steven Nail, PhD, principal scientist at Baxter’s Lyophilization Center of Excellence with extensive expertise in the field, presents...
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.
