Prepare a report (formatting specifications below) outlining the 2020 COVID-19 drug authorization process a Canadian manufacturer of COVID-19 drugs and vaccines could use, as well as the necessary regulatory submission to maintain market authorization. The report should include, but is not limited to the following elements: Purpose/objective/overview of the temporary (interim) authorization pathway. Description of: key elements that were introduced in the temporary authorization pathway to increase authorization efficiency (describe at least 3) the regulatory submission requirements the same manufacturer must fulfill to maintain market authorization following expiration of the interim authorization. Detailed critical analysis of 2 new elements introduced in the temporary authorization pathway. You may select any 2 new elements found in the temporary authorization pathway. Your analysis should indicate the advantages of disadvantages of these two components. The critical analysis should focus on safety and efficacy requirements established in division 8 of the FDR.

Prepare a report (formatting specifications below) outlining the 2020 COVID-19 drug authorization process a Canadian manufacturer of COVID-19 drugs and vaccines could use, as well as the necessary regulatory submission to maintain market authorization. The report should include, but is not limited to the following elements: Purpose/objective/overview of the temporary (interim) authorization pathway. Description of: key elements that were introduced in the temporary authorization pathway to increase authorization efficiency (describe at least 3) the regulatory submission requirements the same manufacturer must fulfill to maintain market authorization following expiration of the interim authorization. Detailed critical analysis of 2 new elements introduced in the temporary authorization pathway. You may select any 2 new elements found in the temporary authorization pathway. Your analysis should indicate the advantages of disadvantages of these two components. The critical analysis should focus on safety and efficacy requirements established in division 8 of the FDR.

Chemistry

10th Edition

ISBN:9781305957404

Author:Steven S. Zumdahl, Susan A. Zumdahl, Donald J. DeCoste

Publisher:Steven S. Zumdahl, Susan A. Zumdahl, Donald J. DeCoste

Chapter1: Chemical Foundations

Section: Chapter Questions

Problem 1RQ: Define and explain the differences between the following terms. a. law and theory b. theory and...

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. An Analytical Chemist is analyzing a protein sample analysis using a light scattering technique. If the formulation of the subject sample has included surfactants or salt additives, which of the following would adequately apply? . The additives would impact the ionic strength of the sample B. The impact of additives influence can be nullified when using a Light Scattering technique. C. The effect of formulation additives would impact the protein sample analysis, and should be considered as a factor when analyzing the protein aggregation using light scattering technique.
You obtained the following raw data when setting up a Bradford standard curve: BSA (mg/ml) Absorbancy 595nm 0 0.225 1 0.310 2 0.420 3 0.510 4 0.610 5 0.720 6 0.810 7 0.915 8 0.950 9 0.980 10 0.990 After blanking against a bradford-dH2O sample, the protein concentration of an unknown sample was determined using the same method and an absorbancy of 0.523 was obtained. Set up a standard curve, excluding outliers (experimental and statistical) and determine the protein concentration in the unknown sample in mg / ml (up to 3 significant figures).
The catalytic efficiency of many enzymes depends on pH. Chymotrypsin, which has a well-known catalytic mechanism, shows a maximum value of kcat/Km at pH 8.0. A) Draw a pH curve of chymotrypsin activity over the pH range of 5 to 10 and briefly explain the rationale within the context of catalysis for your depiction. In particular, note how kcat and Km may change over this pH range. B) Enzymes of the a-amylase family catalyze a reaction by forming a covalent intermediate analogous to chymotrypsin, but to a conserved aspartate residue. Illustrate a catalytic mechanism containing a tetrahedral intermediate for a glycogen debranching enzyme based upon its potential membership in the a-amylase family. (don’t need to draw a whole glycogen)
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A unique plant was discovered from the hot springs of Maquinit, Coron, Palawan. To study the activity of the plant, approximately 5.00 g of the fresh plant was finely cut and ground and then mixed with an extraction buffer to make up a total of 1.00 mL crude plant extract. Approximately 19.00 mL of water was added to the plant extract. To determine the protein concentration of the extract, a bovine serum albumin (BSA) stock solution with a concentration of 200 ug mL-1 was used and mixtures with the following compositions and absorbance readings were prepared: A 200 uL aliquot of the diluted plant extract was added with 300 uL water and was subjected to Bradford assay. Determine the protein concentration, in mg mL-1, of the original 1.00 mL crude extract if the absorbance acquired from the analysis is 0.200.