Name: Thakur Pharmacovigilance For B. Pharm 8th Semester PTU
Brand: Disha Publication
Price: 155 INR
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Thakur Pharmacovigilance For B. Pharm 8th Semester PTU

by Madhurima

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23 Customer Review

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Q1

Is this book strictly aligned with the PTU 8th Semester B. Pharm syllabus for Pharmacovigilance (BP 805T)?

A1

Yes, this textbook is meticulously crafted to cover all five units and sixteen chapters as outlined in the official PTU syllabus for BP 805T, ensuring no topic is missed.
Q2

Does it cover the latest Pharmacovigilance Programme of India (PvPI) guidelines?

A2

Absolutely. The book includes a dedicated section detailing the objectives, structure, and reporting procedures of the PvPI, providing current national context.
Q3

Are coding dictionaries like MedDRA and WHOART explained in detail?

A3

Yes, there are entire chapters dedicated to Drug Dictionaries and Coding, which explain WHOART, MedDRA, Standardized MedDRA Queries (SMQs), and their practical applications in pharmacovigilance.
Q4

Does the book include information on vaccine safety and AEFI (Adverse Events Following Immunization)?

A4

Yes, Module 3 contains a comprehensive chapter on Vaccine Safety Surveillance, covering vaccine pharmacovigilance, AEFI classification, and causality assessment specific to immunizations.
Q5

Is there coverage of pharmacogenomics and its role in ADRs?

A5

Yes, Chapter 13 is specifically dedicated to the Pharmacogenomics of Adverse Drug Reactions, explaining genetic polymorphisms and their impact on drug safety.
Q6

Are CDSCO regulations and Schedule Y discussed?

A6

Yes, the final chapter provides a detailed overview of CDSCO, the D&C Act, Schedule Y requirements for clinical trials, and post-marketing surveillance in India.
Q7

Are causality assessment methods for ADRs explained?

A7

Yes, methods like the Bayesian approach, algorithms, and global introspection for causality assessment are covered in detail in Chapter 2.
Q8

Is drug safety in special populations like pregnant women and the elderly covered?

A8

Yes, Chapter 14 is entirely focused on Drug Safety Evaluation in Special Populations, including pediatrics, geriatrics, and pregnancy & lactation.
Q9

Are active and passive pharmacovigilance methods discussed?

A9

Yes, Chapter 9 on Pharmacovigilance Methods elaborates on passive surveillance (spontaneous reporting), active surveillance (sentinel sites, registries), and observational studies.
Q10

Is this book useful only for PTU students, or can others use it?

A10

While tailored for PTU, the comprehensive coverage of fundamental and advanced pharmacovigilance topics makes it a valuable resource for B.Pharm students of other universities, pharmacy graduates, and professionals entering the field of drug safety.

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Have Doubts Regarding This Product ? Ask Your Question

Q1

Is this book strictly aligned with the PTU 8th Semester B. Pharm syllabus for Pharmacovigilance (BP 805T)?

A1

Yes, this textbook is meticulously crafted to cover all five units and sixteen chapters as outlined in the official PTU syllabus for BP 805T, ensuring no topic is missed.
Q2

Does it cover the latest Pharmacovigilance Programme of India (PvPI) guidelines?

A2

Absolutely. The book includes a dedicated section detailing the objectives, structure, and reporting procedures of the PvPI, providing current national context.
Q3

Are coding dictionaries like MedDRA and WHOART explained in detail?

A3

Yes, there are entire chapters dedicated to Drug Dictionaries and Coding, which explain WHOART, MedDRA, Standardized MedDRA Queries (SMQs), and their practical applications in pharmacovigilance.
Q4

Does the book include information on vaccine safety and AEFI (Adverse Events Following Immunization)?

A4

Yes, Module 3 contains a comprehensive chapter on Vaccine Safety Surveillance, covering vaccine pharmacovigilance, AEFI classification, and causality assessment specific to immunizations.
Q5

Is there coverage of pharmacogenomics and its role in ADRs?

A5

Yes, Chapter 13 is specifically dedicated to the Pharmacogenomics of Adverse Drug Reactions, explaining genetic polymorphisms and their impact on drug safety.
Q6

Are CDSCO regulations and Schedule Y discussed?

A6

Yes, the final chapter provides a detailed overview of CDSCO, the D&C Act, Schedule Y requirements for clinical trials, and post-marketing surveillance in India.
Q7

Are causality assessment methods for ADRs explained?

A7

Yes, methods like the Bayesian approach, algorithms, and global introspection for causality assessment are covered in detail in Chapter 2.
Q8

Is drug safety in special populations like pregnant women and the elderly covered?

A8

Yes, Chapter 14 is entirely focused on Drug Safety Evaluation in Special Populations, including pediatrics, geriatrics, and pregnancy & lactation.
Q9

Are active and passive pharmacovigilance methods discussed?

A9

Yes, Chapter 9 on Pharmacovigilance Methods elaborates on passive surveillance (spontaneous reporting), active surveillance (sentinel sites, registries), and observational studies.
Q10

Is this book useful only for PTU students, or can others use it?

A10

While tailored for PTU, the comprehensive coverage of fundamental and advanced pharmacovigilance topics makes it a valuable resource for B.Pharm students of other universities, pharmacy graduates, and professionals entering the field of drug safety.

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