<?xml version="1.0" encoding="UTF-8"?>
<mods xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="http://www.loc.gov/mods/v3" version="3.1" xsi:schemaLocation="http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-1.xsd">
  <titleInfo>
    <title>Introduction to quality by design in pharmaceutical manufacturing and analytical development</title>
  </titleInfo>
  <name type="personal">
    <namePart>Breitkreitz, Márcia C.</namePart>
  </name>
  <name type="personal">
    <namePart>Goicoechea, Hector C.</namePart>
  </name>
  <typeOfResource>text</typeOfResource>
  <originInfo>
    <place>
      <placeTerm type="code" authority="marccountry">sz</placeTerm>
    </place>
    <place>
      <placeTerm type="text">Cham, Switzerland</placeTerm>
    </place>
    <publisher>Springer</publisher>
    <dateIssued>2023</dateIssued>
    <issuance>monographic</issuance>
  </originInfo>
  <language>
    <languageTerm authority="iso639-2b" type="code">eng</languageTerm>
  </language>
  <physicalDescription>
    <form authority="marcform">print</form>
    <extent>x, 266 pages : illustrations (some color) ; 24 cm</extent>
  </physicalDescription>
  <tableOfContents>Part 1: Quality by Design (QbD)
Chapter 1. Pharmaceutical Quality by Design (QbD) overview and major elements
Chapter 2. Fundamentals of design of experiments and optimization: designs for factor screening and data analysis in pre-response surface methodology
Chapter 3. Fundamentals of design of experiments and optimization: experimental designs in response surface methodology
Chapter 4. Fundamentals of design of experiments and optimization: data modeling in response surface methodology
Chapter 5. Quality by Design in pharmaceutical product and process development
Chapter 6. A Quality by Design update on nano-drug delivery systems
Chapter 7. Control strategies of solid dosage forms by PAT tools
Part 2: Analytical Quality by Design (AQbD)
Chapter 8. Analytical Quality by Design Fundamentals, Compendial and Regulatory Perspectives
Chapter 9. Analytical Target Profile (ATP) and Method Operable Design Region (MODR)
Chapter 10: Quality by Design applications to development of analytical methods for quality control of pharmaceuticals
Chapter 11. Design of Experiments Applied to the Extraction of Active Compounds</tableOfContents>
  <note type="statement of responsibility">Márcia Cristina Breitkreitz, Hector C. Goicoechea, editors.</note>
  <note>Includes index.</note>
  <note>PHR</note>
  <subject authority="lcsh">
    <topic>Drugs</topic>
    <topic>Design</topic>
    <topic>Quality control</topic>
  </subject>
  <subject authority="lcsh">
    <topic>Drugs</topic>
    <topic>Analysis</topic>
  </subject>
  <subject authority="lcsh">
    <topic>Pharmaceutical industry</topic>
    <topic>Quality control</topic>
  </subject>
  <subject authority="lcsh">
    <topic>Drugs</topic>
    <topic>Design</topic>
  </subject>
  <subject>
    <topic>Pharmacy</topic>
  </subject>
  <classification authority="ddc" edition="23">615.19</classification>
  <relatedItem type="series">
    <titleInfo>
      <title> AAPS introductions in the pharmaceutical sciences</title>
    </titleInfo>
  </relatedItem>
  <identifier type="isbn">9783031315046</identifier>
  <location>
    <physicalLocation>Ayesha Abed Library</physicalLocation>
  </location>
  <recordInfo>
    <recordContentSource authority="marcorg">BD-DhAAL</recordContentSource>
    <recordCreationDate encoding="marc">251013</recordCreationDate>
    <recordChangeDate encoding="iso8601">20260702145920.0</recordChangeDate>
    <recordIdentifier source="BD-DhAAL">44937</recordIdentifier>
  </recordInfo>
</mods>
