PDF-Guidance for Industry Incorporation of Physical Chemical Identifiers into Solid Oral Dosage

S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER October 2011 CMC brPage 2br Guidance for Industry Incorporation of Physical Chemical Identifiers into Solid Oral Dosage Form Drug Prod. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub . John . Kunze, Greg . Janée. , and Joan . Starr, California . Digital . Library, University of California. Connecting to. D. ata. Metadata. Publishers. The EZID . Community. Partners (. DataCite. , . Prepared for . CNI Spring Membership Meeting. April 2014. Presented by:. Micah Altman,. . escience@mit.edu. Director of Research, MIT Libraries. Non-Resident Senior Fellow, Brookings Institution. Karen Smith-. perfume evaporating on your skin . perfume evaporating on your skin . physical.  butter melting .  butter melting . physical. wood rotting.  . wood rotting.  . chemical. autumn leaves changing color. for Digital Objects. Why Worry About Identifiers?. Individuals and organizations, including governments and businesses, need to manage increasing amounts of primary and secondary data and increasingly complex and fluid data relationships over long periods of time. Identifiers are essential to this process.. Stephen Davies, Chris Gazey, Anne Wilkins, Dave Gartner. Precision SoilTech. Bindi . Bindi. , . Barley response 2014. 1.06 t/ha. 1.78 t/ha. Nil lime 1996. Nil lime 1996. 1.5 t/ha 2005 injected. 2 t/ha lime 1996. 21. Physical Properties. Chemical Properties. Physical Change. Chemical Change. Chemical and Physical Changes Brain pop. Physical Properties. can be observed or measured without changing the substance.. How to tell the difference. Physical properties. Inherent characteristics of a substance that can be determined without altering its composition. Associated with its physical existence. Color, taste, odor, state of matter (solid, liquid, or gas), density, melting point, boiling point.. Chapter 10. MAT 119. Medication Administration. Medication administration is the way that a drug is introduced into the body. . The route of administration is chosen according to the speed of absorption desired and the site of action of the medication. . BCC Pharmacy Tech . Oral Drugs…. Preferred because they are easy to take and convenient for the patient. . Oral medications are absorbed through the GI tract (mostly the small intestine). . Because of the absorption factor they might not be effective as other forms of medication. . Routes of administration. Chapter Topics. Routes of administration. Oral route of administration. Transmucosal. route of administration. Topical route of administration. Inhalation route of administration. Question 1. Which of the following establishes standards of quality, strength, purity, packaging, and labeling for compounded medications?. USP-NF. FDA. ASHP. DEA. Question 1. Which of the following establishes standards of quality, strength, purity, packaging, and labeling for compounded medications?. Physical and Chemical Changes Physical and Chemical Properties Everything around us has physical and chemical properties. Physical Properties Characteristics you can observe without changing the substance into something new. 5 and 6 . Dr. . . Athmar. . Dhahir. Habeeb. PhD in Industrial pharmacy and drug delivery. athmar1978@uomustansiriyah.edu.iq. athmar1978@yahoo.com. a. th. mar.habeeb.12@ucl.ac.uk. Current Good Manufacturing Practices .