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Showing 181-193 of 193 results

  1. An Integrated Approach to the Preparation of Global CMC Dossiers

    The rapid review and approval of global chemistry, manufacturing, and control (CMC) dossiers requires that technical and managerial staffs in...

    Peter C. Karlton, David Johnston in Drug information journal : DIJ / Drug Information Association
    Article 01 January 1997

  2. General View of Clinical Trials and GCP in East Asia

    This paper presents the background to the DIA Workshop “Clinical Trials and GCP in East Asia,” in which experts from China, Japan, Republic of Korea,...

    Kiichiro Tsutani in Drug information journal : DIJ / Drug Information Association
    Article 01 October 1997

  3. Integration of Immunotoxicology Evaluation in Drug Development

    During the past 20 years, significant progress has occurred in the fields of basic and clinical immunology which has provided newer, more sensitive...

    Jack H. Dean, Bernard Remandet in Drug information journal : DIJ / Drug Information Association
    Article 01 October 1997

  4. The Central Register of Clinical Trials: Current Status of Clinical Research in Poland

    The European Community Directive for good clinical practice (GCP) was introduced as a requirement of the Ministry of Health and Social Welfare in...

    Andrzej Czarnecki in Drug information journal : DIJ / Drug Information Association
    Article 01 July 1997

  5. The Global Registration of Zyprexa™ (Olanzapine)

    The 1995 global registration submissions of olanzapine, a novel agent for the treatment of schizophrenia and related psychosis, represented an...

    Sue T. Worthen, Jeffrey S. Kasher, ... Jeffrey T. Ramsey in Drug information journal : DIJ / Drug Information Association
    Article 01 January 1997

  6. Recent Changes in Clinical Trial Authorization in Eastern Europe

    The aim of the present work was to discuss, from the regulatory point of view, the recent developments in clinical trial authorization in Eastern...

    Tamás L. Paál in Drug information journal : DIJ / Drug Information Association
    Article 01 January 1997

  7. A New and Fast Drug Approval System in Europe

    The European Agency for the Evaluation of Medicinal Products (EMEA) has been operational since February 1995. Primarily responsible for the...

    Fernand Sauer in Drug information journal : DIJ / Drug Information Association
    Article 01 January 1997

  8. “Aboutness” and Other Problems of Text Retrieval in the Pharmaceutical Industry

    In-house text databases of biomedical publications, as used by medical information departments in the pharmaceutical industry, are described in terms...

    Robert Abbott in Drug information journal : DIJ / Drug Information Association
    Article 01 January 1997

  9. UK & Germany: European leaders in disease management

    The UK and Germany appear to be in a better position than other European countries to begin implementing disease management strategies, according to...

    Robert Short in Inpharma Weekly
    Article 01 February 1996

  12. Legislatory Outlook on the Safety of Herbal Remedies

    Just as the first volume of this book series, this second volume starts with an introductory chapter on a general topic. This time the choice has...
    Peter A. G. M. De Smet in Adverse Effects of Herbal Drugs 2
    Chapter 1993
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