Temple of Amenhotep II preliminary report

Inorganic chemistry of the main-group elements, Volume 5 a review of the literature published between October 1975 and September 1976

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Multiple production of hadrons at cosmic ray energies experimental results and theoretical concepts von Fejnberg, Evgenij L.

Strategic zones and global security implications for Japan and the United States

The Federal Reserve A New History von Hetzel, Robert L.

Inhaltsangabe: “… Regulating the Flow of Credit: The "Tenth Annual Report" -- 5.5. Controversy over the Monetary Standard: The Eastern Establishment versus the Populists -- 5.6.  …”
DE-2070s

Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices von Tobin, John J.

Inhaltsangabe: “… 3.5 Drug Delivery -- 3.5.1 Location -- 3.5.2 Drug Characteristics -- 3.5.3 Speed and Duration of Therapeutic Effect -- 3.5.4 Stability -- 3.6 Chapter Review -- 3.7 Further Reading -- Chapter 4 Non‐clinical Studies -- 4.1 Chapter Introduction -- 4.2 Non‐clinical Study Objectives and Timing -- 4.3 Pharmacological Studies -- 4.3.1 Pharmacodynamic Studies -- 4.3.2 Pharmacokinetic/Toxicokinetic Studies -- 4.4 Bioavailability and Bioequivalence -- 4.5 Toxicology Studies -- 4.5.1 Toxicity Studies -- 4.5.2 Genotoxicity Studies -- 4.5.3 Carcinogenicity Studies -- 4.5.4 Reproductive Toxicology Studies -- 4.6 Chemistry, Manufacturing and Control Development (CMC) -- 4.7 Quality by Design (QbD) -- 4.8 Quality of Biotech Products -- 4.8.1 Stability Studies -- 4.9 Good Laboratory Practice (GLP) -- 4.10 Chapter Review -- 4.11 Further Reading -- Chapter 5 Clinical Trials -- 5.1 Chapter Introduction -- 5.2 Clinical Trials -- 5.2.1 Phase I Trials -- 5.2.2 Phase II Trials -- 5.2.3 Phase III Trials -- 5.3 Clinical Trial Design -- 5.4 Good Clinical Practice -- 5.5 Clinical Trials in the EU -- 5.5.1 Sponsor -- 5.5.2 Investigator's Brochure (IB) -- 5.5.3 Investigator -- 5.5.4 Trial Protocol -- 5.5.5 Investigational Medicinal Product Dossier (IMPD) -- 5.5.6 Informed Consent -- 5.5.7 Manufacture of Investigational Medicinal Product -- 5.5.8 Clinical Trial Authorisation -- 5.5.9 Independent Ethics Committee Opinion -- 5.5.10 Amendments to Clinical Trials -- 5.5.11 Case Report Forms (CRFs) -- 5.5.12 Adverse Event Reporting -- 5.5.13 Annual Safety Report -- 5.5.14 Monitoring of Trials -- 5.5.15 End of Trial -- 5.5.16 Trial Master File -- 5.6 Clinical Trials in the US -- 5.6.1 Investigational New Drug Application (IND) -- 5.6.2 Institutional Review Board (IRB) -- 5.6.3 Communication with the FDA -- 5.6.4 Labelling of Investigational Drugs …”
DE-2070s

Taphonomie des petits vertébrés référentiels et transferts aux fossiles : actes de la Table Ronde du RTP Taphonomie, Talence 20 - 21 octobre 2009

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Automated fingerprint identification systems (AFIS) von Komarinski, Peter

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Reports of cases adjudged in the Supreme Court of Pennsylvania von Binney, Horace 1780-1875

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New horizons in international commercial arbitration and beyond

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Simon Commission report on India

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The substance of consciousness a comprehensive defense of contemporary substance dualism von Rickabaugh, Brandon 1976-, Moreland, James Porter 1948-

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A guide to the reports of the United States strategic bombing survey I. Europe. II. The Pacific

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Der Umgang mit Kriegsverbrechen im ehemaligen Jugoslawien 1991-1999 von Zgonjanin, Andrej 1982-

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