April 2017
Volume 29, No. 4 |
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| COVER STORY |
Adeline Siew, PhD
Design of experiment plays a crucial role in the optimization process of formulation development.
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Adeline Siew, PhD
David Fulper, PhD, director of technology support at Catalent, shares insights on the challenges and opportunities for cannabis-based therapeutics.
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Anil Kane
Anil Kane, executive director, Global Head of Formulation Sciences, Pharmaceutical Development Services at Patheon discusses key parameters in the development and manufacturing of oral solid-dosage forms.
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| FORMULATION |
Simon Gaisford
Interpretation of calorimetric data is tricky. The author suggests 10 questions that should be asked of any calorimetric method, along with the rationales behind them.
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| PharmTech Europe April Issue
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Solid Dosage Drug Development and Manufacturing Supplement
Be sure to check out this month's Solid Dosage Drug Development and Manufacturing special issue for articles on PAT, continuous manufacturing and more! The issue also includes our CPhI North America Planning Guide.
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| QUALITY |
Susan Haigney
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
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| ANALYTICAL QUALITY BY DESIGN |
Mark Argentine, Kimber Barnett, Marion Chatfield, Elizabeth Hewitt, Patrick Jackson, Shreekant Karmarkar, Ariane Marolewski, Andrea M. Pless, Andy Rignall, David Semin, Mark D. Trone, Qinggang Wang, Zeena Williams, Yanqun Zhao
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
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| PARTICLE CHARACTERIZATION |
Cathryn Langley
MDRS differentiates the API from the product matrix and enables measurement of particle size and shape.
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| PEER-REVIEWED RESEARCH |
Kieran O'Connor, Nicola Hulme, Yueer Shi
The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
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| OUTSOURCING OUTLOOK |
Vicky Qing XIA
New study shows China biopharma companies face staffing shortages.
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| REGULATORY WATCH |
Sean Milmo
Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party's regulatory authorities in their agreement on GMP inspections.
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| API SYNTHESIS AND MANUFACTURING |
Cynthia A. Challener
Advances in process analytical technology have been achieved, but significant challenges remain.
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| TROUBLESHOOTING |
Jennifer Markarian
The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.
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| ASK THE EXPERT |
Susan J. Schniepp
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
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| EVENTS |
Coventry, United Kingdom
25–26 April 2017
Nice, France
25–28 April 2017
San Diego, US
1–3 May 2017
Floriana, Malta
8–9 May 2017
Philadelphia, US
16–18 May 2017
more events
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