Critical thinking

Critical Thinking Assignment #2 Please read the following project. As part of your response, please provide a reference list with the references you identified from your literature search (in APA format). In the attachment, you will find the rubric. Page limit: 10 pages – There is no page limit for images, tables, references, and appendices. You are a new Quality Assurance associate at XYZ Pharmaceuticals Inc. Utilizing the knowledge gained regarding the drug discovery processes and the product lifecycle management, you are to do the following: 1. Create an imaginary drug and explain the drug discovery process as well as development pipeline and anticipated challenges. • Imaginary drug introduction • drug discovery process • Development Pipeline – Pre-Clinical Testing – Investigational New Drug (IND) Application – Clinical Trials – New Drug Application (NDA) and Regulatory Approval • anticipated challenges 2. Create a sample Standard Operating Procedure (SOP) of one element of the manufacturing process for a novel drug that XYZ Pharmaceuticals is marketing to patients. • Purpose • Scope • Prerequisites • Responsibilities • Procedure • References • Definitions 3. List requirements to obtain regulatory approval in either US or Canada. RUBRIC Course Name: Learner: Contextualization of topic/theme (contextualizes critical analysis/reflection, clear and appropriate focus) [ ] learner identifies theme/framework that spans the required lectures [ ] clear and appropriate focus based on assigned content per Assignment [ ] clear, accurate description of chosen topic Critical analysis and secondary research /1 /15 /60 [ ] subheadings, if used, are clear and descriptive [ ] subheadings are used if they help to identify and organize the themes [ ] literature is critically analyzed (Lecture content may help here) [ ] comparative critical analysis of how literature fits together – do the sources work together? contradict each other? Provide differing views? [ ] original analysis of material, not just a summary [ ] learner uses case study if appropriate (usually appropriate to deeply critically analyze a problem) [ ] learner applies the appropriate theoretical framework from the course materials [ ] learner has demonstrated engagement with appropriate sources/content from lecture/readings/multimedia [ ] learner has provided their reactions after having engaged with the course material (5-7 sentences maximum) [ ] learner has adequately engaged in relevant peer-reviewed sources [ ] learner has demonstrated a clear connection between theme and peer-reviewed literature [ ] Peer-reviewed sources have been appropriately used Writing Mechanics and Academic Integrity (title page, formatting, spelling, grammar, /12 punctuation, length, clarity, organization) [ ] headers [ ] appropriate length [ ] page numbers [ ] organized arguments [ ] title page correctly formatted [ ] spelling errors [ ] font: Times New Roman [ ] grammar/punctuation errors [ ] font size: 12 [ ] capitalization errors [ ] double spaced [ ] sentence structure errors [ ] margins [ ] incomplete sentences [ ] indented paragraphs [ ] inconsistent tenses [ ] all subheadings descriptive, if necessary [ ] unnecessary/inappropriate use of quotes [ ] clear writing style [ ] incorrect formatting of quotes [ ] informal writing [ ] missing words/letters in text [ ] run-on paragraphs [ ] unspecific referrals (i.e.: it, they) Academic Integrity (consistent and precise APA format, proper citations and bibliography) [ ] APA used [ ] in-text citations missing [ ] APA correct [ ] APA incorrectly formatted [ ] APA consistent [ ] APA inconsistent [ ] in-text citations present [ ] bibliography missing [ ] bibliography present [ ] bibliography incorrectly formatted [ ] bibliography correctly APA formatted [ ] bibliography requires minor changes Overall Grade (Summary of above marks, expressed as percentage) /100 Comments: /12