pk-pd.blogspot.com
PK/PD: Bioavailability/Bioequivalence Guidelines
http://pk-pd.blogspot.com/2008/10/bioavailabilitybioequivalence.html
A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Tuesday, October 7, 2008. Abbreviated New Drug Application), you may want to bookmark this page and become familiar with following documents. Note: All links have been updated (March 2014). 1 Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations (Issued 3/2003, Posted 3/19/2003)[ PDF. NEW DRAFT FOR COMMENTS. 10 Bioanalytical Method Validation (05/2001)[ PDF. This ...
pk-pd.blogspot.com
PK/PD: Clinical Pharmacokinetic Studies in Drug Development
http://pk-pd.blogspot.com/2009/06/clinical-pharmacokinetic-studies-in.html
A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Tuesday, June 16, 2009. Clinical Pharmacokinetic Studies in Drug Development. Here goes the list. 1 Single Ascending Dose (SAD). 2 Multiple Ascending Dose (MAD). 3 Food Effect Studies. 4 ADME Mass Balance Studies. 6 Thorough QTc Study. 7 Drug Interaction Studies - Enzyme Inhibition/Induction. 8 Effect of Age and Gender. 9 Special Population - Hepatic Impairment. 10 Special Populaiton - Renal Impairment. I will be b...
pk-pd.blogspot.com
PK/PD: Human Microdosing Studies/ Phase Zero
http://pk-pd.blogspot.com/2008/04/human-microdosing-studies-phase-zero.html
A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Friday, April 25, 2008. Human Microdosing Studies/ Phase Zero. A Phase Zer0 study involves evaluating pharmacokinetics of a drug after administration of sub-therapeutic or sub pharmacology doses to a small group of healthy volunteers. According to. Microdose is defined as dose less than 1/100th of the dose calculated to yield a pharmacological effect or a maximum of. Acceleratoor mass spectrometry (AMS). As such, t...
pk-pd.blogspot.com
PK/PD: June 2013
http://pk-pd.blogspot.com/2013_06_01_archive.html
A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Saturday, June 15, 2013. The Role of Clinical Pharmacology in the Trial of Conrad Murray. One of the key highlights of ASCPT 2013 was the presentation by Dr. Shafer on " The Role of Clinical Pharmacology in the Trial of Conrad Murray. This is a practical example of the utility of PK/PD modeling and simulation. So, sit back and enjoy the presentation. Links to this post. Subscribe to: Posts (Atom).
pk-pd.blogspot.com
PK/PD: June 2009
http://pk-pd.blogspot.com/2009_06_01_archive.html
A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Tuesday, June 16, 2009. Clinical Pharmacokinetic Studies in Drug Development. Here goes the list. 1 Single Ascending Dose (SAD). 2 Multiple Ascending Dose (MAD). 3 Food Effect Studies. 4 ADME Mass Balance Studies. 6 Thorough QTc Study. 7 Drug Interaction Studies - Enzyme Inhibition/Induction. 8 Effect of Age and Gender. 9 Special Population - Hepatic Impairment. 10 Special Populaiton - Renal Impairment. I will be b...
pk-pd.blogspot.com
PK/PD: NONMEM Resources
http://pk-pd.blogspot.com/2008/11/nonmem-resources.html
A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Monday, November 3, 2008. Ok My main objective of this post was to share some resources that are available to learn model data using NONMEM. In addition to the above discussion group, I have learnt immensely from the following resources. A Resources by Nick Holford. These course materials are freely available with enough background information to start performing population PKPD analysis. E Pharmacometrics by ACCP.
pk-pd.blogspot.com
PK/PD: July 2008
http://pk-pd.blogspot.com/2008_07_01_archive.html
A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Monday, July 14, 2008. Clinical Pharmacology and Translational Research. Here is the list of CPTR sessions. Sunday, November 16, 8:30 am – 4:00 pm. Short Course #5: Pharmacodynamic Modeling of Non-standard Endpoints. Tuesday, November 18, 7:00 am – 8:15 am. Clinical Applications of Pharmacogenetics Sunrise Session. Tuesday, November 18, 8:30 am – 11:00 am. Diabetes Disease Progression Modeling Symposium. Symposium ...
pk-pd.blogspot.com
PK/PD: PKPD Regulatory Guidances
http://pk-pd.blogspot.com/2008/12/pop-pkpd-guidances.html
A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Monday, December 15, 2008. After a short hiatus, I am back and hope to continue posting frequently. Ok. If you are planning to work in the industry or already dealing with population PK studies, then you may want to read the guidances pertaining to PK/PD. These guidances provide recommendations on study design, data analysis and report writing which can be very helpful in your work. Population Pharmacokinetics [ PDF.
sfasa.org
Data Mining training Feb 15-16, 2007 and May 10-11, 2007 in SanFrancisco
http://www.sfasa.org/trainingsem.htm
Register Now for the BAPKPD 2011 Poster Social - September 21, 2011. Dear BAPKPD Network Members and Associates,. You are cordially invited to participate in the 2011 BAPKPD Poster Social. 2011 BAPKPD Poster Social. Wednesday September 21, 2011 from 1–5 PM PDT. Mission Bay Conference Center at UCSF (Robertson Auditorium). 1675 Owens Street, San Francisco, CA 94143-3008. This year we are pleased to have FDA’s Division of Pharmacometrics. PhD give our plenary podium Pharmacometrics. Li Yan, Treasurer.
pk-pd.blogspot.com
PK/PD: Pharmacometric Tutorials
http://pk-pd.blogspot.com/2013/12/pharmacometric-tutorials.html
A blog with random discussions on pharmacokinetics, pharmacodynamics and drug development. Wednesday, December 25, 2013. Some additional tutorials for learning population PK modeling and simulation have been published by CPT: Pharmacometrics and Systems Pharmacology. And are available for free under open access. Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development. A Time to Event Tutorial for Pharmacometricians. Topics include: R programming for pharmacometrics, introducto...
