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Risk Management Strategies for Safety Qualification of Extractable and Leachable Substances in Therapeutic Bio
Ingrid Markovic, Ph.D., U.S. Risk Management Strategies for Safety Qualification of Extractable and Leachable Substances in Therapeutic Bio.
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A Discussion of the Physiochemical Factors that Regulate the Leaching of Organic Substances from Plastic Conta
_ A Discussion of the Physiochemical Factors that Regulate the Leaching of Organic Substances from Plastic Conta.
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Nucleic Acid Amplification EUR' Based Rapid Microbiological Methods:
Claudio D.Denoya, Ph. D, Microbiological Technical Assessment Group Parenteral Center of Emphasis, Last year marked the 25th anniversary of the first description of the Polymerase Chain Reaction (PCR), a process used to make a large...
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Molecular Imaging in Oncology Drug Development:
Helen Young, Ph.Senior Imaging Scientist Nuclear Medicine techniques of gamma scintigraphy (planar imaging and single photon computed emission tomography (SPECT)) and positron emission tomography (PET) are not new technologies. There...
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Strategies for Handling Impurities in Excipients:
The traditional approach of considering excipients as relatively marginal to the main business of producing blockbusting active ingredients is changing rapidly under the pressure of evolving regulatory guidelines.Therefore, better control...
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Biowaivers in the United States, European Union, and Japan
Biowaivers are waivers of clinical bioequivalence studies.Bioequivalence studies are often required for generic drugs or small changes in drug products that evolve during drug development to ensure equivalence with dosage forms proven to...
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Application of PAT to API Synthesis from R&D to Manufacturing
Darryl J.Ertl, Susan E. Barnes, Ph. D., Bob E. Cooley & Charles A. Goss, Ph. Process Analytical Technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and...
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Consensus Rating Methods for Small and Large Virus-Retentive Filters
Richard Levy, Ph.D., Parenteral Drug Association (PDA) Virus filtration is routinely employed as part of a protein drug manufacturer's comprehensive virus safety strategy [1, 2]. Virus retentive membranes are incorporated into housing...
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Functionality and Performance of Excipients in a Quality-by-Design World. Part 3:
As I wrote in my earlier columns, excipients are going to be a major part of pharmaceutical formulation Quality by Design (QbD).It thus follows that excipient quality will also be an important part of QbD and Design Space. We therefore...
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A Systematic Approach to RP-HPLC Method Development in a Pharmaceutical QbD Environment
Yan Li, Ph.D., Gerald J Terfloth, Ph. & Alireza S Kord, Ph. D., Analytical Sciences, Chemical Development, GlaxoSmithKline Since first initiated by the U.S. Food and Drug Administration (FDA) in its 'Pharmaceutical cGMPs for the...
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