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The Importance of Zeta Potential for Drug/Gene Delivery in Nanomedicine
11 Apr 2012 | Online Presentations | Contributor(s): James Leary
Malvern Instruments Workshop: Nano-particle Characterization Symposium
11 Apr 2012 | Workshops | Contributor(s): James Leary
BME 695L Lecture 15: GMP and Issues of Quality Control Manufacture of Nanodelivery Systems
02 Dec 2011 | Online Presentations | Contributor(s): James Leary
See references below for related reading.
15.1.1 What does cGMP mean?
15.1.2 Why GMP? Controlling processes means more predictable outcomes…
15.1.4 What can be learned from the semi-conductor industry clean-room and manufacturing?
15.1.5 What doesn’t fit this paradigm?
15.2 cGMP-level manufacturing
15.2.1 Predictable methods lead to predictable products
15.2.2 The CFR (Code of Federal Regulations) sections on GMPs
15.2.3 What is covered under cGMP?
15.3.1 So what is special about biomanufacturing?
15.3.2 Nano-clean water necessary for nano-pharmaceuticals
15.3.3 Contaminants at the nano-level
15.3.4 Can you scale up the process?
15.4 Some quality control issues – how to test
15.4.1 Correctness of size – size matters!
15.4.2 Composition – atomic level analyses
15.4.3 Monodispersity versus agglomeration
15.4.4 Order and correctness of layers2
15.4.5 Correctness of zeta potentials
15.4.6 Does the nanomedical system contain the correct payload?
15.4.7 Targeting (and mis-targeting) specificity and sensitivity
BME 695L Lecture 16: FDA and EPA Regulatory Issues
16.1 Introduction and overview
16.1.1 How does the FDA think about nanomedical systems?
16.1.2 The 2006 Nanotechnology Task Force
16.2 Some details of the Nanotechnology Task Force Report
16.2.1 General findings of the report
16.2.2 Some initial recommendations of the Task Force
16.2.3 Where the FDA may need to meet EPA on nanoscale materials
16.2.4 Will FDA re-visit GRAS products containing nanomaterials?
16.3 How will the FDA consider nanomedical systems?
16.3.1 Nanomedical systems are integrated nanoscale drug and drug delivery devices
16.3.2 Either a drug or a device? How about a "Combination Product"?
16.3.3 Drug-Biologic combination products
16.4 Types of human clinical trials
16.4.2 “Phase 0”
16.4.3 Phase 1
16.4.4 Phase 2
16.4.5 Phase 3
16.4.6 Phase 4
16.5 EPA and other regulatory agency issues
16.5.1 Assessing environmental impact of emerging nanotechnologies
16.5.2 Concept of life cycle assessment (LCA)
16.5.3 Toxicity of nanomaterials
16.5.4 Some recommendations of the 2006 International Conference on Nanotechnology and Life Cycle Assessment
16.6 Nanotechnologies and the workplace
16.6.1 NIOSH – Formulating workplace safety standards for nanotechnology
16.6.2 Protecting workers in the workplace
16.6.3 Assessing hazards in the workplace
16.6.4 Establishing a Nanotechnology Safety System
16.7 The future of nano-healthcare products
BME 695L Lecture 12: Assessing Drug Efficacy and Nanotoxicity at the Single Cell Level
22 Nov 2011 | Online Presentations | Contributor(s): James Leary
12.1 Introduction to measures of efficacy for nanomedicine
12.1.1 for evaluation purposes, does structure/size reveal function?
12.1.2 nanomedical treatment at the single cell level requires evaluation at the single cell level
12.1.3 the difficulty of anything but simple functional assays (e.g. phosphorylated “functional” proteins)
12.1.4 the need for assays which at least show correlation to functional activity
12.2 Quantitative single cell measurements of one or more proteins per cell by flow and image/confocal cytometry
12.2.1 cell surface measures of protein expression on live, single cells
12.2.2 high-throughput flow cytometric screening of bioactive compounds
12.2.3 challenges of measuring protein expression inside fixed, single cells
12.2.4 when location is important 2D or 3D imaging is required to get spatial location of proteins inside cells (“locational proteomics” at the single-cell level)
12.3 Quantitative multiparameter phospho-specific flow/image cytometry as a single-cell,structural-functional measurement
12.3.1 attempts to measure "functional proteins" by detecting phosphorylation
12.3.2 example of phospho-specific, multiparameter flow cytometry
12.3.3 example of measuring single cell gene silencing by phospho-specific flow cytometry
12.4 Quantitative measures of gene expression – the promises and the realities
12.4.1 is gene expression at the single cell level really possible?
12.4.2 is it even useful to measure a single gene's changes?
12.4.3 gene arrays of purified cell subpopulations
12.4.4 RNA amplification techniques to attempt to perform single cell gene arrays
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