CTD Assignment

To complete Module 4 & 5 Quality:


Utilize your package insert (PIL) found online as your primary resource, other resources may include articles found in ASU library, google, Overview of Pharmacodynamics
https://www.merckmanuals.com/professional/clinicalpharmacology/pharmacodynamics/overview-of-pharmacodynamics
DO NOT USE WIKIPEDIA AS A REFERENCE

Module 4 Nonclinical Study Reports
4.2 Study reports – headline in TOC
4.2.1 Pharmacology https://www.fda.gov/media/72033/download
4.2.1.1 Primary pharmacodynamics – sub headline in TOC
In a paragraph summarize primary pharmacodynamics.
Identify the dose for your drug from your PIL.
4.2.1.2 Secondary pharmacodynamics
In a paragraph summarize secondary pharmacodynamics.
4.2.1.3 Safety pharmacology
In a paragraph summarize safety pharmacology.
4.2.1.2 Pharmacodynamic drug interactions
In a paragraph summarize pharmacodynamic drug interactions.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3444856/
4.2.2. Pharmacology
4.2.2.1 Analytical methods and validation reports
https://www.sciencedirect.com/science/article/pii/S002235491548788X
https://link.springer.com/article/10.1208/aapsj0901004
https://onlinelibrary.wiley.com/doi/pdf/10.1002/0470042206.app7
In a paragraph describe analytical methods validation.

In a paragraph describe the importance of absorption.
4.2.2.3 Distribution https://www.sciencedirect.com/topics/pharmacologytoxicology-and-pharmaceutical-science/drug-distribution
In a paragraph describe what affects drug distribution.
4.2.2.4 Metabolism
https://www.sciencedirect.com/topics/chemistry/pharmacological-metabolism
In a paragraph describe metabloism.
4.2.2.5 Excretion
https://www.sciencedirect.com/topics/pharmacology-toxicology-andpharmaceutical-science/drug-excretion
https://www.merckmanuals.com/professional/clinical-pharmacology/pharmacokinetics/drugexcretion
In a paragraph describe excretion.
4.2.2.6 Pharmacokinetics https://www.merckmanuals.com/professional/clinicalpharmacology/pharmacokinetics/overview-of-pharmacokinetics
In a paragraph describe pharmacokinetics.
4.2.2.7 Other pharmacokinetic studies
https://www.merckmanuals.com/professional/clinicalpharmacology/pharmacokinetics/overview-of-pharmacokinetics
In a paragraph describe other pharmacokinetic studies.
4.2.3 Toxicology https://www.fda.gov/media/71542/download
4.2.3.1 Single dose toxicity (Species and route)
https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceuticalscience/single-dose-toxicity-study
In a paragraph describe single dose toxicity and routes.
4.2.3.2 Repeat dose toxicity (Species, route, duration)
https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceuticalscience/repeat-dose-toxicity-study
In a paragraph describe repeat dose toxicity.

In a paragraph describe genotoxicity.
4.2.3.4 Carcinogenicity https://www.sciencedirect.com/topics/medicine-anddentistry/carcinogenicity
In a paragraph describe carcinogenicity.
4.2.3.5 Reproductive and developmental toxicity
https://www.fda.gov/media/72231/download
In a paragraph describe reproductive and development toxicity.
4.2.3.6 Local tolerance http://www.creative-animodel.com/toxicology/nonclinical-local-tolerance-studies.html
In a paragraph describe local tolerance.
4.2.3.7 Other toxicity studies
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3127354/
In a paragraph describe other toxicity studies.
4.3 Literature references
List all references used for this module here using APA style.

Module 5 Clinical Study Reports
5.2 Tabular listing of all clinical study reports – headline in TOC
Create a table from the headings under this section – column for study type, column for author
(this is you), column for clinical study site (b creative and name your clinical study site)
5.3 Clinical study reports and related information
5.3.1 Reports of biopharmaceutical studies
5.3.1.1 Bioavailability (BA) Study reports and related information
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4157693/
In a paragraph describe BA.

5.3.1.2 Comparative BA and bioequivalence (BE) Study reports and related
information
https://www.cadth.ca/sites/default/files/pdf/What_Are_Bioavailability_and_Bioeq
uivalence_e.pdf
In a paragraph compare BA and BE.
5.3.1.3 In Vitro – in Vivo correlation Study reports and related information
https://www.nuventra.com/resources/blog/what-is-ivivc/
In a paragraph describe in vitro – in vivo correlation.
5.3.1.4 Reports of bioanalytical and analytical methods for human studies
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5762214/
In a paragraph describe bioanalytical methods for human studies.
5.3.2 Reports of studies to pharmacokinetics using human biomaterials
5.3.2.1 Plasma protein binding Study reports and related information
https://www.sciencedirect.com/topics/neuroscience/plasma-protein-binding
In a paragraph describe plasma protein binding.
5.3.2.2 Reports of hepatic metabolism and drug interaction studies
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4309630/
In a paragraph describe hepatic metabolism and drug interactions.
5.3.2.3 Reports of studies using other human biomaterials
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3698935/
In a paragraph describe human biomaterials.
5.3.3 Reports of human pharmacokinetic (PK) studies
5.3.3.1 Healthy subject PK and initial tolerability Study reports and related
information https://clinicaltrials.gov/ct2/show/NCT03492385
https://www.fda.gov/media/84920/download
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6278009/
In a paragraph describe healthy subject PK and initial tolerability.
5.3.3.2 Patient PK and initial tolerability Study reports and related information
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6342261/

In a paragraph describe patient PK and initial tolerability.
5.3.3.3 Intrinsic factor PK Study reports and related information
https://www.nuventra.com/resources/blog/intrinsic-and-extrinsic-factors/
In a paragraph describe intrinsic factor PK.
5.3.3.4 Extrinsic factor Study reports and related information
https://accp1.onlinelibrary.wiley.com/doi/full/10.1002/cpdd.577
In a paragraph describe extrinsic factor.
5.3.3.5 Population PK Study reports and related information
https://www.nuventra.com/resources/blog/what-is-population-pk-poppk/
In a paragraph describe population PK.
5.3.4 Reports of human pharmacodynamic (PD) studies
5.3.4.1 Healthy subject PD and PK/PD Study reports and related information
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4112793/
In a paragraph describe PD and PK/PD studies in healthy subject.
5.3.4.2 Patient PD and PK/PD Study reports and related information
https://ascopubs.org/doi/full/10.1200/EDBK_180460
In a paragraph describe PD and PK/PD studies in patients.
5.3.5 Results of efficacy and safety studies
5.3.5.1 Study reports and related information of controlled clinical studies
pertinent to the claimed indication https://www.fda.gov/media/93569/download
In a paragraph describe controlled clinical studies.
5.3.5.2 Study reports and related information of uncontrolled clinical studies
https://www.winchesterhospital.org/health-library/article?id=21898
In a paragraph describe uncontrolled clinical studies.
5.3.5.3 Reports of analysis of data from more than one study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2042957/

In a paragraph describe analysis of data from more than one study.
5.3.5.4 Other Study reports and related information
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5427231/
In a paragraph describe other study reports.
5.3.6 Reports on postmarketing experience https://www.sciencedirect.com/topics/pharmacologytoxicology-and-pharmaceutical-science/postmarketing-surveillance
In a paragraph describe postmarketing experience.
5.4 Literature reference
List all references used for this module here using APA style.

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