Erratum to: A fresh look at analytical methods for vaccines

In the section SPECIFICATIONS & THEIR ROLE IN THE VACCINE ANALYTICAL METHOD LIFECYCLE (paragraph 2, pp 248–249), the original article read:

• A definition of satisfactory patient outcome (e.g., equal to 95% efficacy) is translated to a limit on a vaccine biomarker (correlate of protection);

• The correlate of protection is used in vaccine clinical studies to define a limit on a critical quality attribute (a specification limit);

• The specification limit is used to define limits on critical process parameters (a design space).

The corrected article reads:

• A definition of satisfactory patient outcome (e.g., p_limit equal to 95% efficacy) is translated to a limit on a vaccine biomarker (correlate of protection; z_limit);

• The correlate of protection is used in vaccine clinical studies to define a limit on a critical quality attribute (a specification limit; y_limit);

• The specification limit is used to define limits on critical process parameters (a design space; x_limit).

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In the same section (paragraph 4, p. 249), the original article read:

Thus, limits in Figure 1 (e.g., or Design Space) are derived from the appropriately budgeted portions of the specification range.

The corrected article reads:

Thus, limits in Figure 1 (e.g., x_limit or design space) are derived from the appropriately budgeted portions of the specification range.

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In the sub-section Method control (paragraph 2, p. 252), the original article read:

In this depiction the specification limit (or the analytical budget, ) is used to define the ATP , where v and w represent performance parameters such as accuracy and precision. The relationship between a critical method parameter (u) and performance parameters can be used to derive a method parameter limit (, in red), while the relationship between a suitability parameter (s) and the performance parameters can be used to derive a system suitability limit (, in green).

The corrected article reads:

In this depiction the specification limit (or the analytical budget, y_limit) is used to define the ATP (v_limit, w_limit), where v and w represent performance parameters such as accuracy and precision. The relationship between a critical method parameter (u) and performance parameters can be used to derive a method parameter limit (u_limit, in red), while the relationship between a suitability parameter (s) and the performance parameters can be used to derive a system suitability limit (s_limit, in green).

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In the same sub-section (paragraph 4, p. 252), the original article read:

System suitability parameters provide additional control. Like critical parameter parameters, these can be established through a model between performance characteristics...

The corrected article reads:

System suitability parameters provide additional control. Like critical method parameters, these can be established through a model between performance characteristics...

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In the sub-section Some statistical opportunities (paragraph 2, p. 254), the original article read:

U_RV=tα,n–1) (σ ⁄ √n). The factor  is a statistical constant associated with a probability equal to α and with n–1 degrees of freedom.

The corrected article reads:

U_RV=t_α,n–1) (σ ⁄ √n). The factor t_α,n–1 is a statistical constant associated with a probability equal to α and with n–1 degrees of freedom.