Pregnancy and the pharmaceutical industry : the movement towards evidence-based pharmacotherapy for pregnant women /: the movement towards evidence-based pharmacotherapy for pregnant women. ([2019])

• Record Type: Book
• Further Information: Note: Kristine E. Shields.
• Authors: Shields, Kristine E
• Contents: Part I. The Background, the Debate, and the Ethics Involved 1. Drug Testing and Pregnant Women: Background and Significance 2. The Rationales For and Against Inclusion 3. The Ethics Involved Part II. Quantitative and Qualitative Discoveries 4. A Measure of Exclusion 5. Perspectives from the Industry: On Exclusion 6. Perspectives from the Industry: On Inclusion 7. Perspectives from the Industry: On Litigation, Regulation, Incentives, and Indemnity 8. Perspectives from the Industry: On Ethics Part III. Uniting the Regulators, the Industry, and the Advocates 9. The FDA Guidance, Public Comment, and Affinity with Stakeholders 10. Proposed Actions for FDA and the Pharmaceutical Industry 11. A Chance at Change 12. After the Guidance Appendices FDA Guidance Document - Pregnant Women: Scientific and Ethical Consideration for Inclusion in Clinical Trials Taskforce on Research Specific to Pregnant Women and Lactating Women: Report to the Secretary, Health and Human Services. Executive Summary
• Publisher Details: London : Academic Press
• Publication Date: 2019
• Copyright Date: 2019
• Extent: 1 online resource
• Subjects: 618.2061; Obstetrical pharmacology; MEDICAL / Gynecology & Obstetrics; Electronic books
• Languages: English
• ISBNs: 9780128190746; 0128190744
• Related ISBNs: 9780128185506
• Notes: Note: Includes bibliographical references and index.; Note: Online resource; title from PDF title page (EBSCO, viewed June 3, 2019).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.