How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms: From Conception to Post-Approval

by Mittal, Bhavishya

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Title Statements

  • Full title :How to Develop Robust Solid Oral Dosage Forms : From Conception to Post-Approval.

Edition Statements

  • Publication Date:2016.

Publication Statements

  • Publisher(s):Elsevier Science
  • Place of Publication:Saint Louis
  • Language:eng
  • Publication Date:2016.

Notes

3.4.1.2 Step 2-Determination of Preliminary Composition Based on Granulation Strategy.

The Physical Object

  • Description:1 online resource (192 pages)

Edition Identifiers

  • ISBN:9780128047323, 0128047321
  • oclc:ocn961064973
  • LC Classification:RM300.M588 2017
  • Dewey Decimal:615.1

Table of Contents

Front Cover; How to Develop Robust Solid Oral Dosage Forms; How to Develop Robust Solid Oral Dosage Forms: From Conception to Post-Approval; Copyright; Contents; Author Biography; Foreword; Preface; Acknowledgments; About the Expertise in Pharmaceutical Process Technology Series; FORMAT; SUBJECT MATTER; TARGET AUDIENCE; List of Abbreviations and Acronyms; 1 -- Rules of Drug Product Development; 1.1 INTRODUCTION; 1.2 THE BIG PICTURE; 1.3 RULE 1: BIOPHARMACEUTICS AND BIOAVAILABILITY; 1.4 RULE 2: MANUFACTURABILITY; 1.5 RULE 3: STABILITY; 1.6 RULE 4: BUSINESS ACUITY; 1.7 BRING IT TOGETHER.

1.7.1 Understanding the Regulatory Landscape1.7.2 Understanding and Cultivating Partnerships; 1.7.3 Understanding Time Lines; 1.7.4 Anticipating Uncertainties; 1.8 CLOSING THOUGHTS-DEVELOPING A PROBLEM-SOLVING ATTITUDE; REFERENCES; 2 -- Pharmacokinetics and Preformulation; 2.1 BIOPHARMACEUTICS AND PHARMACOKINETICS; 2.1.1 Key Concepts; 2.1.2 Assessment of Bioavailability; 2.1.3 First-pass Effect and Relative Bioavailability; 2.2 DRUG TRANSPORT IN SOLID ORAL DOSAGES; 2.2.1 Passive Diffusion; 2.2.2 The pH-Partition Hypothesis.

2.2.3 Mechanisms of Drug Absorption-From Ingestion to Systemic Circulation…

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Subjects

Médicaments -- Formes pharmaceutiques s… Solid dosage forms

Writers

Mittal, Bhavishya

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