Protein biology and biologic medications

CHAPTER 1

Protein biology and biologic medications

Discussing the fundamentals of protein synthesis - a process that produces some of the most used biologics and their biosimilars
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Biologic and biosimilar manufacture

CHAPTER 2

Biologic and biosimilar manufacture

Covering development and manufacture of a biologic or biosimilar, inherent variability and quality management
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Biologic product stability – background theory

CHAPTER 3

Biologic product stability – background theory

Detailing the types of factors affecting stability and degradation of biologics and biosimilars, and the studies used to measure
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Interpretation of stability data

CHAPTER 4

Interpretation of stability data

Describing factors to consider for interpretation of stability and the associated data
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Excipients

CHAPTER 5

Excipients

Including reasons for use and classification of excipients and how they maintain biologic or biosimilar stability and integrity
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Approving a biosimilar

CHAPTER 6

Approving a biosimilar

Summarising the regulatory principles underlying biosimilar approval and how this differs from the reference biopharmaceutical and small molecule generics
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Immunogenicity

CHAPTER 7

Immunogenicity

Discussing factors effecting immunogenicity and resultant safety and efficacy of a biopharmaceutical
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Pharmacovigilance

Chapter 8

Pharmacovigilance

Evaluating why pharmacovigilance is essential to characterise the safety and efficacy of biopharmaceuticals and biosimilars
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Biosimilars in practice

Chapter 9

Biosimilars in practice

Detailing what to consider when reviewing a biosimilar for inclusion in a formulary and the role of pharmacists in implementing biosimilars into the health service
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Patient considerations and communication

chapter 10

Patient considerations and communication

Discussing the educational needs of patients about biosimilars and the pharmacists’ role in delivering advice and support to patients taking biosimilars
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Other educational activities

Core handbook

Includes chapters on stability, immunogenicity, pharmacovigilance and biosimilars in clinical practice

Expert webinars

Watch experts discuss using biosimilars with real-world cases

Resource library

A selection of evidence-based and peer-reviewed literature with summaries of key guidance of biosimilar use