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Pharmaceutical Quality Headlines

Synta Gets FDA Nod to Resume Developing Skin Cancer Drug
Reuters (03/02/10) Dey, Esha

Fosamax: Is Long Term Use of Bone Strengthening Drug Linked to Fractures?
ABC News (03/09/10) Romo, Christine; Salahi, Lara

New Approach to Immune Cell Analysis Seen as First Step to Better Distinguish Health and Disease
NIH News Release (03/08/10)

Drug Makers Decry Indian Patent Law
Wall Street Journal (02/11/10) Anand, Geeta

Complimentary AAPS E-Learning Module To Discuss Liposomal and Nanoparticle Agents
AAPS Press Release (02/23/2010)

WHI Study Data Confirm Short-Term Heart Disease Risks of Combination Hormone Therapy for Postmenopausal Women
NIH News Release (02/15/10)

One-Third of Antimalarial Medicines Sampled in Three African Nations Found to Be Substandard in Large-Scale USP-WHO Study
USP (02/08/2010)

FDA Official Cleared of Conflict-of-Interest Allegations in Heparin Case
Los Angeles Times (02/06/10) Zajac, Andrew

The European Medicine Agency Road Map to 2015: The Agency's Contribution to Science, Medicines, Health
European Medicines Agency (01/26/2010)

New Guidelines Suggest Botox for Cerebral Palsy
Business Week (01/25/10) Preidt, Robert

Tolerability and Safety of Ropinirole Versus Other Dopamine Agonists and Levodopa in the Treatment of Parkinson's Disease: Meta-Analysis?
Drug Safety (02/10) Vol. 33, No. 2, P. 147; Kulisevsky, Jaime; Pagonabarraga, Javier

Guidance for Industry: Assessment of Abuse Potential of Drugs
FDA.gov (01/27/10)

Safety-Related Regulatory Actions for Orphan Drugs in the U.S. and E.U.: A Cohort Study
Drug Safety (02/10) Vol. 33, No. 2, P. 127; Heemstra, Harald E.; Giezen, Thijs J.; Mantel-Teeuwisse, Aukje K.; et al.

Public Health in Focus at International Conference
PR Web (01/27/10)

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The Analysis and Pharmaceutical Quality (APQ) Section of the American Association of Pharmaceutical Scientists (AAPS) is composed of members whose interests are in the areas of analytical methods development for bulk drug substances as well as drugs in pharmaceutical dosage forms and biological matrices, and methods and procedures for assuring that quality is designed into pharmaceutical products. APQ provides a forum for the exchange of information pertaining to analytical techniques, bioanalytical techniques, regulatory and compendial issues, and assurance of quality. The APQ Section interacts with all disciplines involved in the discovery, development and production of pharmaceutical products, and many of its programs and activities are undertaken with other sections of the association. More...


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Education Initiatives (Word Document)

Conducted April 30, 2009 Organized by the APQ Section
Key Factors to Design Quality Stability Program for Drug Products and API, Kim Huynh-Ba, Pharmalytik
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2008 APQ Membership Meeting

2009 APQ Goals

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Leadership Column
Date Posted: October, 2008
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Links to Focus Groups
API Manufacturing Technology
Bioanalytical
Contract Research Organization (CRO)
Chemisty, Manufacturing, & Controls (CMC)
Generic Pharmaceuticals
In Vitro Release & Dissolution Testing
Ligand Binding Assay Bioanalytical
Microdialysis
Non-Clinical Dose Formulation Analysis
Process Analytical Technology
Nutraceutical
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APQ Section Important Dates

MONTH EVENT LOCATION CONTACT
March 2010
12 Section Election Slates Due Karol Shadle
16 NBCPC Conference Call 12:00pm (Noon) EST Sharon Pichon
17 EC Conference Call 2:00 pm EST Karol Shadle
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