Health Canada/FDA Favorite Links Lynda Paleshnuik Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009.

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Health Canada/FDA Favorite Links Lynda Paleshnuik Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009

Assessment of Interchangeable Multisource Medicines, Kenya, August |2 | Health Canada Favorites Main Agency Site: “Drugs and Health Products” Drug Products:

Assessment of Interchangeable Multisource Medicines, Kenya, August |3 | Health Canada Favorites Drug Product Guidance documents: General: demande/guide-ld/index-eng.php Chemical Entity Products/Quality demande/guide-ld/chem/index-eng.php

Assessment of Interchangeable Multisource Medicines, Kenya, August |4 | Health Canada Favorites Included in Quality Guidance Documents: Drug Master Files Pharmaceutical Sciences – Questions and Answers Impurity Guidances Inhalation and Nasal Products Aqueous Solutions

Assessment of Interchangeable Multisource Medicines, Kenya, August |5 | Health Canada Favorites General Quality Guidance for New and Generic Applications Stability Testing Stereochemical Issues

Assessment of Interchangeable Multisource Medicines, Kenya, August |6 | Health Canada Favorites Pharmaceutical Sciences – Questions and Answers demande/guide-ld/chem/ps_qa_sp_qr-eng.php Pharmaceutical Quality of Aqueous Solutions demande/guide-ld/chem/aqueous_aqueuses-eng.php

Assessment of Interchangeable Multisource Medicines, Kenya, August |7 | Health Canada Favorites Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format demande/guide-ld/ctd/ctdnds_ctdpdn-eng.php Summary basis of decision (SBD) smd/phase1-decision/index-eng.php

Assessment of Interchangeable Multisource Medicines, Kenya, August |8 | Health Canada Favorites DIN guidelines for quality information demande/guide-ld/chem/dinas_ddin-eng.php “Regardless of the information provided by the supplier of the drug substance, the manufacturer of the dosage form is responsible for ensuring that acceptable specifications and properly validated analytical procedures for the drug substance are developed by the manufacturer’s facilities and for providing the results of batch analyses performed at the manufacturer's facilities.”

Assessment of Interchangeable Multisource Medicines, Kenya, August |9 | FDA Favorites FDA Guidance Documents (searchable): yInformation/Guidances/default.htm All Chemistry Guidances: yInformation/Guidances/ucm htm

Assessment of Interchangeable Multisource Medicines, Kenya, August | FDA Favorites Searchable Drug Database: Inactive Ingredients List (Searchable):

Assessment of Interchangeable Multisource Medicines, Kenya, August | FDA Favorites Searchable dissolution method database: