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  • Writer's pictureLast Bench Pharmacist

Pharm D 5th Year Clinical Research PDF Notes


As you embark on your 5th year of the Pharm D journey, clinical research takes center stage. This crucial field bridges the gap between scientific discovery and tangible patient care. This Pharm D 5th Year Clinical Research PDF Notes comprehensive guide dives into the heart of clinical research, equipping you with the knowledge and resources to excel in this dynamic area. Through clear explanations, practical examples, and readily downloadable PDF notes, we'll explore the intricacies of clinical trial design, ethical considerations, regulatory frameworks, and your vital role in shaping the future of pharmaceutical advancements. Get ready to unlock the fascinating world of clinical research and prepare to contribute meaningfully to this ever-evolving field.


Pharm D Clinical Research PDF Notes
Pharm D Clinical Research PDF Note

Scope

Gaining in-depth understanding of the various stages involved in developing new drugs, from pre-clinical testing to clinical trials and regulatory approval. Learning the different types of clinical trials, their design principles, methodologies, and data collection processes. Emphasizing the ethical principles governing clinical research, including informed consent, patient safety, data privacy, and responsible conduct.


Objectives:-

Upon completion of the subject student shall be able to (Know, do, appreciate) –

a. Critically evaluate the design and conduct of clinical trials;

b. Apply statistical methods to analyze clinical trial data and draw valid conclusions;

c. Communicate clinical research findings effectively, both orally and in writing;

d. Identify and address ethical issues in clinical research;

e. Understand the regulatory requirements for conducting clinical trials.


Pharm D 5th Year Clinical Research PDF Notes

Part A


Unit 1


Drug development process




Pharm D 5th Year Clinical Research PDF Notes

Part B


Unit 1


Introduction to Clinical trials




Unit 2


Various phases of clinical trial




Unit 3


Methods of post marketing surveillance




Unit 4


Abbreviated New Drug Application submission




Unit 5


Good Clinical Practice




Unit 6


Challenges in the implementation of guidelines




Unit 7


Ethical guidelines in Clinical Research




Unit 8


Composition, responsibilities, procedures of IRB / IEC




Unit 9


Overview of regulatory environment in USA, Europe and India




Unit 10


Role and responsibilities of clinical trial personnel as per ICH GCP




Unit 11


Designing of clinical study documents




Unit 12


Informed consent Process




Unit 13


 Data management and its components




Unit 14


Safety monitoring in clinical trials




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