BioMed Research International

Modern Approaches to Quality Assurance of Drug Formulations

Publishing date
06 Feb 2015
Submission deadline
19 Sep 2014

1University of Veterinary and Pharmaceutical Sciences Brno, Brno-Královo Pole, Czech Republic

2Callum Consultancy, Devon, USA

3Midwestern University, Downers Grove, USA

4University of Macau, Macau, China

Modern Approaches to Quality Assurance of Drug Formulations


Developments in pharmaceutical sciences have resulted in sophisticated systems to modify drug action by delaying its onset, slow the rate of delivery to reduce side effects, or maintain constant plasma levels to sustain drug action. More novel modes of delivery have also gained prominence. These may provide, for example, transdermal drug delivery and time-based (chronotherapeutic) release or may target specific organs, tissues, or cellular structures as in cancer therapy. Numbers of biopharmaceutical products have also increased greatly in recent times and will probably continue to do so.

Novel systems, therapeutic agents, and evolving paradigms on quality assurance present many challenges. At the same time they afford opportunities for developing and propounding new philosophies and technologies for assuring quality and performance. In particular, they promise reduced emphasis on end product testing if dosage form design and manufacture is appropriate, with testing of input materials and in-process testing/monitoring largely replacing end product testing. The same principles apply to quality assurance of devices used for sophisticated delivery because these too may influence parameters such as amount, rate, and possibly time of drug delivery.

With these considerations in mind we invite authors to submit original research or review articles related to these developments. Articles might concern but need not be restricted to:

  • The active pharmaceutical ingredient
  • Dosage form design
  • The process for product manufacture
  • Assurance of product quality and performance

Topics can include analytical as well as process technologies and how these might complement each other.

Potential topics include, but are not limited to:

  • Development and testing of novel/innovative dosage forms
  • Development and testing of multifunction excipients
  • Preparation, characterization, formulation, and testing of nanoparticles
  • Preparation, characterization, and utilization of pharmaceutical cocrystals and solid dispersions
  • Innovative analytical techniques and their applications in process monitoring, analysis, and control
  • Dynamic dissolution approaches, in vitro-in vivo correlation
  • Quality assurance/control of active pharmaceutical ingredients, excipients, packaging, devices, and finished dosage forms
  • Solid state forms of drugs and excipients: analytical assessment and consequences for process and quality attributes
  • PAT applications in manufacture
  • Regulatory acumen
  • Drug counterfeiting and how to counteract it
BioMed Research International
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