Why Standards Are Important for Global Pharma

30 04 2013


Tony DeStefanoTony DeStefano, Ph.D., is the 2013 AAPS president.

The ever-increasing globalization of the pharmaceutical industry has enabled patient access to more medicines throughout the world. Globalization has also created more opportunities in new markets for the pharma enterprise worldwide. However, elements of globalization have also created layers of complexity never before encountered based on traditional models for pharmaceutical research and development, manufacturing, distribution, and regulation. More than ever before, standards must play a central role in ensuring the quality, safety, and efficacy of pharmaceutical products made and distributed around the world so that ultimately, the end user—the patient—remains protected.

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How Pharmaceutical Science is Covered by the Media: The Good, the Bad, and the Ugly

30 04 2013


Karen AddisKaren Addis is vice president, U.S. Health Sciences Practice at Environics Communications in Washington, D.C.

Pharmaceutical science is a hot and thriving industry. In fact, the Bureau of Labor Statistics predicts above average job growth in the field. It represents the wave of the future. But as pharmaceutical scientists, you already know that.

What it means to the rest of society is that they will be interested in hearing about the exciting advances that are taking place in the industry. That, in turn, means there will be continued interest by the media to cover pharmaceutical science. And that’s good news.

However, with the continued downsizing in newsrooms across the country, reporters are increasingly stretched thin. The number of seasoned journalists with in-depth knowledge of any industry are becoming fewer. That’s the bad news.

Those deep cuts in the newsroom have resulted in an increasing number of younger reporters…

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Glass Delamination: A Quality Problem for Parenterals

30 04 2013


Satish SinghSatish Singh, Ph.D., is research fellow at Pfizer, where his responsibilities include leading product development activities for biologics, vaccines, and oligonucleotides.

Glass packaging is ubiquitous in the pharmaceutical industry and most formulators take it for granted. “Make mine Type 1 please, and I will have a few hundred thousand of them to go.” However, glass is a complex material and the raw material, the glassmaking process, and the process of forming the vials and syringes each have a significant impact on the final quality of the material we use.

The glass we think of as strong has a chemical weakness. Under certain conditions, thin slivers (lamellae) of glass can flake off from the inside of the containers and contaminate the drug product solution—and they can be difficult to detect.

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Pharmacy Practice Issues and Facility Qualifications in Sterile Product Compounding

30 04 2013


Margaret RicciHans-Christian MahlerMargaret Speed Ricci is director of drug product development at Amgen, Inc., in Thousand Oaks, Calif.
Hanns-Christian Mahler, P.D., Ph.D., is head of pharmaceutical development and supplies, PTD Biologics EU, F.Hoffmann-LaRoche Ltd (Basel, Switzerland).

The fungal meningitis outbreak associated with tainted steroid injections from the New England Compounding Center has highlighted questions about the product needs of hospitals and clinics, as well as the quality assurance of pharmacies that produce compounded sterile products. Virtually all single-use parenteral biologic therapeutic solutions for IV infusion or freeze-dried powders for injection require sterile compounding steps, such as reconstitution, dilution, or preparation of an IV bag for patient administration.

In-use studies must demonstrate chemical and physical stability to justify the acceptability of interim holding conditions of the prepared solution for a given recommended storage temperature and time duration.

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Making Pharmacology “Visible”

30 04 2013


Brian MoyerBrian Moyer is currently contracted to the Biomedical Advanced Research and Development Authority, Health and Human Services, Washington, D.C., as senior science advisor, Project BioShield, Chemical, Radiologic and Nuclear Threats, through Tunnell Government Services, Bethesda, Md.

“Modern medicine” has morphed into “molecular medicine,” and it has taken on this new identity in part due to the capabilities of imaging. Imaging used to mean the view through the microscope, but advances over the years in photomultiplier tubes and collimation led to nuclear medicine imaging in the 1950s, and computational techniques with data storage and advances in electronic miniaturization led to new clinically important 3-D imaging systems in the latter half of the past century. In the 21st century we now have the capability of viewing biology using an extraordinary variety of imaging platforms that can contribute dramatically to our understanding of drug and biologics mechanisms of action as well…

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Nonclinical Dose Formulation Analysis: Application of GLP Principles to Validation, Analysis, and OOS Investigations of Nonclinical Dose Formulations

30 04 2013


Teresa HenryTeresa R. Henry, Ph.D., currently serves as the associate director of quality control at Optimer Pharmaceuticals, Inc.

Nonclinical pharmacokinetic and toxicokinetic safety studies are performed using good laboratory practice (GLP) regulations to ensure the availability of safe medicines. International GLP regulations uniformly require that dose concentration, homogeneity/uniformity, and stability be established prior to administration.

But the Food and Drug Administration and the Organisation for Economic Cooperation and Development both proclaim that GLPs do not apply to validation of analytical methods used to determine the concentration of GLP test article in drug dosage forms. Yet the outcome of nonclinical toxicology safety studies is fundamentally dependent upon accurate and precise dose formulations. Therefore, formulation method validation and sample analysis for supporting nonclinical toxicology studies should be consistently conducted around the world under the framework of GLP principles.

View original post 131 more words

Nonclinical Dose Formulation Analysis: Application of GLP Principles to Validation, Analysis, and OOS Investigations of Nonclinical Dose Formulations

30 04 2013

Nonclinical Dose Formulation Analysis: Application of GLP Principles to Validation, Analysis, and OOS Investigations of Nonclinical Dose Formulations.

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