Ajaz PowerPoint PPT Presentations

Traditional Dosage form Immediate release Direct compression Wet granulation Dry granulation Buccal tablets Sub-lingual tablets Capsules Hard gelatin Soft gelatin ...

Ajaz S. Hussain, Ph.D. Director (Act.), Office of ... Barry Rothman, Office of Compliance, CDER, FDA, 1999. aaps Annual Meeting. 31 ... Chairperson: Steve Byrn ...

Questions for the Science Board. PAT Initiative. FDA Science Board Meetings (11/01, 4/02) Emerging Science Issues in Pharmaceutical Manufacturing ...

FDA Science Board Meetings (11/01, 4/02) Emerging Science Issues in Pharmaceutical Manufacturing ... for Pharmaceutical Science (PAT Subcommittee) deliberations ...

IN VITRO PHYSICAL-CHEMICAL PROPERTIES. IN VIVO PHYSICAL-CHEMICAL PROPERTIES ... PHARMACOKINETIC PROPERTIES. Typical CMC and cGMP Considerations ...

Second Meeting of the FDA/ACPS Process Analytical Technology: Closing Remarks Ajaz S. Hussain, Ph.D. Deputy Director Office of Pharmaceutical Sciences

Methods for Assessing Bioequivalence of Topical Products: How should FDA Redirect its Research Program? Ajaz Hussain, Ph.D. Director (Act.), Office of Testing and ...

Higher Testosterone Concentrations in Type 2 Diabetic Men Treated with Metformin Ajaz Banka , MBBS Sandeep Dhindsa , MD Paresh Dandona , MD Introduction One third of ...

Cronologia de los Eventos de la Biblia en el A.Testamento. Panorama Bíblico

Ron Neil Mike Francone. Rick Morton Gary Chaloner. Steven ... Felicia Maloney. University of Oregon. Joel Jaeggli. Hans Kuhn Lucy Lynch. The Measurement Factory ...

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... Critical Path to. New Medical ... How should FDA support the case for a focused effort on ' ... Support for Generic Drugs Efficient methods for ...

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Janet Woodcock. CDER, FDA. Doug Dean and Frances Bruttin ... Dr. Woodcock's presentation summary. Measurement Shows Potential for Improvement. 0 ...

black-box' controls. Quality-by-Inspection. III. Process Analysis Technology. BASS XI ... components and. processes. Current PQRI proposal. and draft Guidance ...

Current Status of System for Ensuring Drug Quality. US Drug products are of high quality, BUT ... How to encourage innovation while ensuring high quality ...

Bioavailability of Dietary Supplements: Key Issues in Defining the Research Agenda ... need to be developed for formulation optimization of nutritional supplements ...

The Process Analytical Technology (PAT) Initiative: Progress Report ... AstraZeneca (Plankstad), Barton Creek, GMP (Athens), CAMP, PITTCON,MCEC,.. PAT Track #2 ...

time (fasting) = variable; T50%=15 min. Permeability - Low , compared ... Volume (fasting) = what gets emptied SI vol.(500 ml?) pH = 3-8, surface tension low, ...

RL Williams et al, Pharm Res, 2002;19:359-66 ... Meiyu Shen (FDA) Yi Tsong (FDA) Walter Hauck (Thomas Jefferson University) Roger Williams (USP) ...

Florence Fang. Div. of Labeling and Program Support. Peter Rickman. Div. of Chemistry III ... Outside of OPS - other parts of CDER organization ...

We have no preconceived thoughts on how products need to be developed and ... in our thinking and not have preconceived ideas as to how follow-ons should be regulated ...

AAPS 39th Annual Pharmaceutical Technologies Conference at Arden House ... A Historical Note on Quality: Lurching from Fad to Fad? Sampling Plans ( 50s) ...

Should this be similar to current regulatory decision criteria for food-drug or ... administration of high alcohol loads (to emulate a 'worst case' scenario) and a ...

320.24 Types of evidence to measure bioavailability or establish bioequivalence (a) BA may be measured or BE may be demonstrated by several in vivo and in vitro ...

ICH Q8 is a Door Opener for. Describing Quality by Design ... Und messbar machen was noch nicht messbar ist! Galileo Galilei. 1564-1642 ...

como el sauce junto al agua, a tu orilla, por el aire. la luz de nieve en la rama. ... Mar a dijo: Aqu est la esclava del Se or, que me suceda como dices. Meditamos: ...

La situaci n del mundo Ca 1200 1050 aC. 2. Israel en Cana n: los dos primeros siglos. ... Los estados rivales, reglas y religiones.

Trial-and-Error DOE CAD. Dosage forms Drug Delivery Systems Intelligent Drug ... validation exercise precedes a trouble-free time period in the manufacturing ...

Keith Webber, CDER/FDA. Frank Holcomb, CDER/FDA. Moheb Nasr, CDER/FDA ... William Bargo (CVM) Brenda Uratani (CDER) Reviewers: Norman Schmuff (CDER) Lorenzo ...

Mouse. Chimeric. Human. Humanized. Fc binding & Effector Function. Nature of target interaction ... Harvest. Proteolytic Steps. Diafilt./Conc. Lyophilization ...

... (development and) manufacturing is evolving from an art form to one that ... Continuous 'real time' assurance of quality. http://www.fda.gov/cder/gmp ...

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - CMC ... 1 Metered Dose Inhaler and Dry Powder Inhaler CMC Draft Guidance, Oct 1998 ...

Process Analytical Technologies (PAT) Sub-Committee Report ACPS Meeting October 21, 2002 Tom Layloff, Ph.D. Meetings February 25 and 26, 2002 Applications & Benefits ...

Mouse. Chimeric. Human. Humanized. Overview. Definitions. Relevant Product Attributes ... Harvest. Proteolytic Steps. Diafilt./Conc. Lyophilization ...

... and are identical in strength or concentration (e.g. ... meet compendial or other applicable standards of strength, quality, purity, and identity; ...

examine current state of the supplemental change approval process, specifically ... Present a summary of FDA's current thinking and activities regarding the ...

... the API Serves As the. Process Quality Surrogate Marker. Uni-variate handle on a poly-variate process. Focus on API with little regard for excipients and process ...

Fundamental science and engineering principles generally less well developed ... Encourage development of fundamental science and engineering principles ...

Global Manufacturing and Supply. Purpose ... Global Manufacturing and Supply. Objectives. To advance dialogue on the implementation of RMM ...

Lydia Gilbert-McClain Robert Meyer. Gur Jai Pal Singh (Chair) Wallace Adams Dale Conner ... Eugene Sullivan. Wallace Adams (Chair) James Allgire Charles ...

... sample, and adequacy of risk coverage (e.g. ... This can be catastrophic for the business and availability of. Important drugs. A Warning Letter ...

... subsystem and design variables in one subsystem may be controlled by other ... exists (e.g., in mechanical engineering - design of aircrafts) that addresses ...

Knowledge Space' Molecular mechanism of action. Biological Plausibility ... Awareness of the nuts & bolts of many review issues. Multiplicity is a challenge ...

New Raman Instrumentation and Applications for QA/QC and PAT. History of Raman Spectroscopy ... improvements in instrumentation have allowed users to focus on their ...

Gary Buehler, Robert West, Rita Hassall, Brenda Arnwine, Gururaj Bykadi, James ... of pH), partition coefficient, polymorphism, hygroscopicity, and melting points? ...

Absence of critical information on pharmaceutical development prevents full ... Focuses resources on critical issues ... Peer/critical review of CMC evaluation ...

... do not yet share it, is an attitude that only hinders progress.' Mahatma Gandhi ... Industry reluctant to use new technology ...

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