Whitepapers - Pharmaceutical Technology

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Whitepapers

505(b)(2): Fast and Cost-Effective Drug Approval

September 25, 2012

Looking to identify a new product for development? Ready to roll over a compound into a new application? The 505(b)(2) pathway is a fast and cost-effective route for drug approval. With global reach across 26 countries, Camargo Pharmaceutical Services executes 505(b)(2) programs for both small and large molecules.

Microbial Identification by MALDI-TOF Mass Spectrometry

September 25, 2012

Choosing a microbial identification platform is complicated by the evolving number of technologies available for use. One of the newest identification systems utilizes MALDI-TOF mass spectrometry. We describe the technology behind this platform and discuss our experiences with the system’s performance when used for routine identification of environmental microorganisms.

FT-IR Analysis of Dimethicone Based on USP-Specified Method

September 1, 2012

When analyzing viscous solutions by FTIR spectroscopy, the ATR method is particularly effective because the close contact between the sample and prism is easily achieved. This application illustrates an example with the analysis of dimethicone, with good repeatability clearly obtained.

FDA & ICH: Regulations and Standards for Temperature-Controlled Supply Chains

August 28, 2012

This paper discusses a scientific approach to cold chain management, overview of ICH guidance, three key FDA regulations, and examples of cold chain 483 observations.

Amorphous Local Structure and Property Prediction

August 28, 2012

Characterization of a variety of X-ray amorphous materials has shown that different types of local molecular order can exist for organic systems. In silico energy minimization can give potential local structures that might exist in the amorphous state. This approach is efficient, and useful for determining properties such as stability and local molecular order which can aid manufacturing and intellectual property considerations.

Mixing Powder 101: Basic Principles of Mixing

August 28, 2012

On September 19, Hosokawa will host a free, online educational seminar on the basic principles of mixing and blending dry powders using a variety of batch and continuous mixing technologies. This webinar will explore the fundamental benefits and limitations of screw mixers, ribbon blenders, paddle mixing, high versus low shear applications, tumble blenders and other devices used for mixing applications.

An Overview of the Principles of MSE

June 1, 2012

Waters MSE is a simple, generic method that enables you to obtain "all of the data all the time" in a single analysis. Learn about the key requirements of a comprehensive quantitative and qualitative analytical workflow and gain an understanding of the three stages of MSE.

ACQUITY UPLC H-Class Bio with 2D Technology

June 1, 2012

Using the ACQUITY UPLC® H-Class Bio System with 2D technology, a method was developed to determine monoclonal antibody concentration and mass profile from a single injection. The system delivered the necessary reproducibility in terms of retention time, recovery, and response for samples from complex matrices using both UV and MS detection.

Elemental Impurities: Navigating the Proposed Regulations of USP <232> and <233>

June 1, 2012

The implementation of the proposed chapters USP chapters on elemental impurities, <232> and <233> is best suited to the use of closed vessel digestion and analysis by an ICP analytical technique. This paper addresses the challenges involved, as well as appropriate methods, procedures, and limits associated with this analysis.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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