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Pregnancy and the Pharmaceutical Industry
The Movement towards Evidence-Based Pharmacotherapy for Pregnant Women
Outlines how to deliver evidence-based pharmaceutical care to pregnant women to improve maternal and neonatal health
Kristine E. Shields (Author)
9780128185506
Paperback, published 24 May 2019
244 pages
22.9 x 15.1 x 1.6 cm, 0.41 kg
Approx.222 pages
Part I. The Background, the Debate, and the Ethics Involved1. Drug Testing and Pregnant Women: Background and Significance2. The Rationales For and Against Inclusion3. The Ethics Involved Part II. Quantitative and Qualitative Discoveries4. A Measure of Exclusion5. Perspectives from the Industry: On Exclusion6. Perspectives from the Industry: On Inclusion7. Perspectives from the Industry: On Litigation, Regulation, Incentives, and Indemnity8. Perspectives from the Industry: On Ethics Part III. Uniting the Regulators, the Industry, and the Advocates9. The FDA Guidance, Public Comment, and Affinity with Stakeholders10. Proposed Actions for FDA and the Pharmaceutical Industry11. A Chance at Change12. After the Guidance AppendicesFDA Guidance Document - Pregnant Women: Scientific and Ethical Consideration for Inclusion in Clinical TrialsTaskforce on Research Specific to Pregnant Women and Lactating Women: Report to the Secretary, Health and Human Services. Executive Summary
Subject Areas: Life sciences: general issues [PSA], Pharmacology [MMG], Clinical trials [MBGR1]
