'Stability data' presentation slideshows

Gabriel K. Kaddu WHO Prequalification of Medicines Programme Assessment training, Copenhagen

Stability Principles and Case Studies: Active Pharmaceutical Ingredient (API) and Finished Pharmaceutical Product (FPP). Gabriel K. Kaddu WHO Prequalification of Medicines Programme Assessment training, Copenhagen May 2014. Overview. Purpose of stability

678 views • 67 slides

ACKNOWLEDGEMENTS

Overview of Guidance Documents and Decision process: Biopharmaceutics Section Mehul Mehta, Ph.D. Director Division of Pharmceutical Evaluation I OCPB, CDER, FDA. ACKNOWLEDGEMENTS. Dr. Uppoor Dr. Marroum. Outline. Overview of biopharmaceutical aspects of dissolution related guidances

1.38k views • 59 slides

Pharmaceutical Development with Focus on Paediatric formulations

844 views • 59 slides

FDG and its intended regulation by FDA in the USA: Points to Ponder

FDG and its intended regulation by FDA in the USA: Points to Ponder. Pradeep K. Garg, Ph.D. Director, PET Center Wake Forest University Health Sciences Winston Salem, NC; USA. STOP. PET Center. Three major domains: Radiopharmaceutical area: Chemist

511 views • 38 slides

578 views • 36 slides

Tormidiagramm

503 views • 33 slides

Multiple Storage Conditions: Accumulating Uncertainty

Multiple Storage Conditions: Accumulating Uncertainty. Brad Evans Pfizer MBSW, May 23, 2012. Question. How to model Stability across: DS storage, multiple temperatures/times DP storage, multiple temperatures/times We run studies at each temperature, in parallel (to save the time)

430 views • 32 slides

Stephen E. Zweig, Ph.D. CEO, CliniSense Corp.

261 views • 26 slides

Establishment of Health Level 7 (HL7) Standard for Submission of XML Stability Data

Establishment of Health Level 7 (HL7) Standard for Submission of XML Stability Data. Norman R. Gregory Chemist Division of Manufacturing Technologies. http://www.hl7.org. Background. Stability Data a major component of quality submissions

399 views • 22 slides

Regulating Animal Drugs

Regulating Animal Drugs . Mrs. Brandi Robinson Office of New Animal Drug Evaluation Center for Veterinary Medicine. Regulating Animal Drugs. Protect the Public Health by ensuring safe and effective animal drugs reach the market unsafe and ineffective animal drugs do not reach the market.

385 views • 21 slides

Stability measurements in Nb 3 Sn strands with various wire and sub-element diameters

Stability measurements in Nb 3 Sn strands with various wire and sub-element diameters. The Ohio State University C.J. Kovacs M.D. Sumption E.W. Collings M. Majoros X. Xu. Hyper Tech Research, Inc. X. Peng. Acknowledgements.

198 views • 19 slides

FDA Standards Development and Implementation

Pharm Toxicology Advisory Subcommittee Meeting June 10, 2003. FDA Standards Development and Implementation. Randy Levin, M.D. Director, Office of Information Management Center for Drug Evaluation and Research Food and Drug Administration. Overview. Standards organizations

265 views • 15 slides

WP 4.2 review meeting

Status of the ESA work... bino@hep.ucl.ac.uk. WP 4.2 review meeting. Wednesday, 13 September 2006, UCL, bino@hep.ucl.ac.uk. Introduction, Overview of the completed runs. January testrun : - commissioning of BPMs 31,31 and 1,2 (41,42) - readout, processing software etc... April run :

196 views • 12 slides

HEALTHY LIVING - NATURALLY

114 views • 11 slides