Pharm D 5th Year Clinical Research PDF Notes

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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.

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