When it comes to DITA specializations in pharmaceutical technical documentation, standardized templates or schemas are not universally defined, as the specific requirements for pharmaceutical content can vary widely among organizations and regulatory bodies. However, there are common practices and guidelines that pharmaceutical companies often follow to create their DITA specializations tailored to their unique needs.

Customization Based on Industry Standards

Pharmaceutical organizations typically start by customizing existing DITA frameworks or templates to align with industry standards and their specific documentation requirements. These customizations may include the creation of new DITA elements and attributes tailored to pharmaceutical content, such as drug formulations, clinical study data, adverse event reporting, and regulatory submissions. While there are no one-size-fits-all standardized templates, pharmaceutical companies often reference established industry standards like CDISC (Clinical Data Interchange Standards Consortium) and SPL (Structured Product Labeling) as a foundation for their DITA specializations.

Collaboration with Industry Consortia

Pharmaceutical companies often collaborate with industry consortia and working groups to develop and refine DITA specializations that align with the latest industry trends and regulatory requirements. These collaborations may result in the creation of industry-specific DITA specialization guidelines and best practices that organizations can leverage to ensure consistency and compliance with pharmaceutical standards. These guidelines may not be rigid templates but provide valuable guidance on structuring content effectively within the DITA framework.

Example:

Here’s an example of a customized DITA specialization for pharmaceutical documentation based on industry standards:

<pharmaceutical-product id="product123">
  <product-name>Acme Drug</product-name>
  <formulation>
    <active-ingredient>DrugX</active-ingredient>
    <dosage>10 mg</dosage>
  </formulation>
  <clinical-study id="study1">
    <study-title>Efficacy and Safety Study</study-title>
    <study-phase>Phase III</study-phase>
    <study-results>...
  </clinical-study>
  <regulatory-submission id="submission1">
    <submission-type>New Drug Application</submission-type>
    <submission-date>2023-11-15</submission-date>
  </regulatory-submission>
  <content>...

This example demonstrates a customized DITA specialization for pharmaceutical product documentation, including details about the product’s formulation, clinical study data, and regulatory submissions. While not a standardized template, this customization aligns with industry standards to capture essential pharmaceutical information.