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Pharmaceutical Quality Headlines

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)

AAPS to Host 45th Annual Pharmaceutical Technologies Arden Conference
AAPS Press Release (01/26/2010)

FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety Monitoring System
FDA.gov (01/08/10)

Laboratory Tests in the Clinical Risk Management of Potential Drug-Drug Interactions
Drug Safety (12/10) Vol. 32, No. 12, P. 1189; Geerts, Arjen F.J.; De Koning, Fred H.P.; De Smet, Peter A.G.M.; et al.

Leading Medication Development Researcher Phil Skolnick Joins NIDA to Lead Drug Discovery Efforts
NIH News Release (01/18/10)

FDA Against Wider Approval of Forest Drug
Reuters (01/07/10) Richwine, Lisa

FDA Approved 26 New Drugs in 2009, Compared With 25 in 2008
Wall Street Journal (01/05/10) Favole, Jared A.

Popular Drugs May Help Only Severe Depression
New York Times (01/06/10) Carey, Benedict

AstraZeneca's Swine Flu Nasal Spray Recalled for Lower Potency
Business Week (12/23/09) Randall, Tom

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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...


APQ Headlines

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

2009 Objectives for APQ

 
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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
Stability



















APQ Section Important Dates

MONTH EVENT LOCATION CONTACT
February 2010
9 APQ Section Conference Call 1:00 pm EST Sherry Martin
16 NBCPC Conference Call 12:00pm (Noon) EST Sharon Pichon
17 EC Conference Call 2:00 pm EST Karol Shadle
American Association of Pharmaceutical Scientists
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