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The article presents the analysis of the World Health Organization Expert Committee on the collaborative studies about the international standards for testing and detection of hepatitis B surface antigen (HbsAg) and anti-hepatitis C virus antibodies. These studies aim to replace the International Standard for HbsAg and to assess its suitability for replacement preparation and calibration. The Committee assesses that the studies have appeared to be adequate in the area.

The article presents the analysis of the World Health Organization Expert Committee on the collaborative studies about cytokines, growth factors and endocrinological substances. These studies aim to assess the relative activities of preparations of natural and recombinant interferon beta in a range of bioassays and to establish reference materials on the area. Furthermore, the Committee had recommended the validity of these studies.

The article presents the analysis of the World Health Organization Expert Committee on the collaborative studies which aim to replace the current International Reference Preparation. These collaborative studies had assessed the relative sensitivity of cell culture assays and chorioallantoic membrane egg assays for smallpox vaccines as well as potency determination of yellow fever vaccines. Futhermore, the Committee stresses their agreement on the content of the studies.

The article focuses on the international guidelines and recommendations developed by the World Health Organization Expert Committee which depict on the manufacturing and quality control of biological products. The Committee has developed a draft for nonclinical evaluation of vaccines, which is intended to set principles as well as provide information and guidance to vaccine manufacturers. The Committee also reviewed the draft for the production and control of pneumococcal conjugate vaccines.

The article offers information about the activities of the World Health Organization Expert Committee on the development of biological standards. The Committee has established a standardization program, which aims to develop recommendations for quality standards, provision of reference materials, and consensus on quality-related issues for biologicals. Furthermore, the Committee has developed of a vaccine for severe acute respiratory syndrome.

The article presents the analysis of the World Health Organization Expert Committee on the proposed international reference panels for validation of serological and nucleic acid based tests on hepatitis B and hepatitis C detection. The Committee has revealed progress on the development of the international reference preparation which is designed to assist the analytical sensitivity of tests to all hepatitis B surface antigen tests kits worldwide. Meanwhile, standard for heparin was introduced.

Annex 1 of the book "WHO Expert Committee on Biological Standardization: fifty-second report" is presented. It provides outline of the international regulatory expectations which are applicable to the different stages of vaccine development and marketing approval. It explores further guidance on preclinical and laboratory evaluation of vaccines.

The article presents the analysis of the World Health Organization Expert Committee on the international standards and reference reagents for biological substances. The Committee has revealed that they did not received any response to an inquiry concerning on the continued need of the international standards for amikacin, lymecycline, and chlortetracycline as well as for porcine calcitonin. Furthermore, the Committee reviewed the diagnostic tests using nucleic acid based techniques.

The article offers information about the activities of the World Health Organization (WHO) Expert Committee on the development of biological standards. Biological standards include guidelines and recommendations in increasing the use of molecular methods for the characterization of vaccines. WHO also established workshops and seminar sessions in dealing with blood products as well as consultation on bioterrorism in preparation for terrorism-related incidents.

The article focuses on the international guidelines and recommendations developed by the World Health Organization Expert Committee which depict on manufacturing and quality control of biologicals. These international guidelines are developed to provide guidance on regulatory expectations for clinical evaluation of vaccines. Furthermore, the organization recommended vaccines for meningococcal polysaccharide and has established international workshops on antivenoms.

The article presents the updated version of the World Health Organization (WHO) Model List of Essential Medicines adopted at the meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines on March 31 to April 3, 2003 in Geneva, Switzerland, explanatory notes and supporting background information relating to the use and development of the Model List.

Chapter 7 of the book "The Selection and Use of Essential Medicines" is presented. It highlights the recommendations of the World Health Organization (WHO) Expert Committee for additions, deletions, and other changes to the WHO Model List of Essential Medicines. It presents the criteria for classifying medicines as either core or complementary list medicines. Recommendations on the use of the square box symbol and the review of the antihypertensive medicines are also cited.

The article presents the analysis of the World Health Organization Expert Committee on the collaborative studies about the international standard for Factor VIII, low-molecular-weight heparin, and prekallikrein activator. These collaborative studies aimed to establish common batch of the reference preparation, provide information on relative clinical values of different assays, and replacement of European Pharmacopoeia reference preparations. The Committee also shows impression on the studies.

The article presents the analysis of the World Health Organization (WHO) Expert Committee on collaborative studies depicting cytokines, growth factors, and endocrinological substance. The Committee stresses their appreciation on the study which appropriately considered the valuable reagents of human chorionic gonadotrophin immunoassays. They also recommended the study on the suitability of a lyophilized recombinant human ciliary neurotrophic factor as Reference Reagent for bioassay.

Chapter 2 of the book "The Selection and Use of Essential Medicines" is presented. It offers information about the open session held as part of the meeting of the World Health Organization (WHO) Expert Committee on the Selection and Use of Essential Medicines on March 31 to April 3, 2003 in Geneva, Switzerland.

The article presents the analysis of the World Health Organization Expert Committee on the collaborative studies about the standardization of human papillomavirus vaccine and human immunodeficiency virus (HPV) neutralizing antibody assays. These studies are designed to harmonize diagnostic procedures for HPV DNA detection and evaluation. Furthermore, the Committee stresses that these studies should include neutralizing assays and emphasizes their agreement on the proposed course of action.

The article presents the analysis of the World Health Organization Expert Committee on the collaborative studies about the preparation, characterization and establishment of biological reference materials. The Committee stresses that the collaborative study failed to include restrictions on the methods that will take into account on a given preparation. Furthermore, the Committee suggests that the choice of unit used in the collaborative study must be based on physicochemical information.

The article presents the analysis of the World Health Organization (WHO) Expert Committee on the proposed establishment of the study on pertussis toxin standard as the International Standard for histamine-sensitizing. The Committee has revealed the standard relation between the National Insittute for Biological Standard and Control and the pertussis toxin assays. However, the Committee found that these assays appeared to differ in specific pertussis toxin activity.

Chapter 9 of the book "WHO Expert Committee on Specifications for Pharmaceutical Preparations" is presented. It focuses on quality assurance in terms of risk analysis of pharmaceutical starting materials. It explores the risk analysis in quality control and impurities as well as the application of hazard analysis and critical control point methodology for pharmaceuticals.

Chapter 10 of the book "WHO Expert Committee on Specifications for Pharmaceuticals Preparation" is presented. It describes a pre-qualification system being developed by the World Health Organization (WHO) for suppliers of pharmaceuticals products. It also highlights the procedure for evaluating the suppliers of drugs for the treatment of HIV/AIDS.

Chapter 8 of the book "WHO Expert Committee on Specifications for Pharmaceutical Preparations" is presented. It focuses on quality assurance in terms of distribution and trade-related aspects of pharmaceutical starting materials. It also explores the World Health Organization (WHO) certification scheme on the quality of pharmaceutical products moving in international commerce.

Chapter 13 of the book "WHO Expert Committee on Specifications for Pharmaceutical Preparations" is presented. It presents information on various topics related to pharmaceutical industry including the collaboration between the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP). Also stated in the chapter is the availability of a CD-ROM which contains a searchable version of "The International Pharmacopoeia" in English, French and Spanish.

Chapter 7 of the book "WHO Expert Committee on Specifications for Pharmaceutical Preparations" is presented. It focuses on quality assurance in terms of inspection of pharmaceutical starting materials. It tells about the model certificate of good manufacturing practices (GMP) as well as the guidance for GMP inspection report.

The article presents the analysis of the World Health Organization Expert Committee on the collaborative studies about anti-toxoplasma serum, human. The Committee stresses that the studies had assessed the suitability of the candidate preparation for use in cell-killing assays and calibration. However, the value assignment results obtained in the study were found to be based on accepted gold standard method, which means that it cannot directly replaced the existing anti-toxoplasma standard.

Information about several papers discussed at the World Health Organization Expert Committee on Biological Standardization meeting is presented. The meeting highlights the vital role of the Committee in preparing recommendations for the development and distribution of biological products. Several resolutions on quality, safety, and efficacy of medicines, blood products, and vaccines were endorsed.

The article presents the analysis of the World Health Organization Expert Committee on the proposed establishment of antibodies against human platelet antigen 5b as a Reference Reagent. This material is part of the collaborative studies which describes the calibration of a freeze-dried preparation of pooled human plasma. However, the Committee revealed that they did not received this proposal and therefore it needs further discussion for approval.

Information about several papers discussed at the World Health Organization Expert Committee on Biological Standardization meeting is presented. The meeting highlights the increasing complexity, sophistication, and number of biological products. Major challenges on standardization and development of traditional biologicals were discussed.

Chapter 1 of the book "The Selection and Use of Essential Medicines" is presented. It offers information about the meeting of the World Health Organization (WHO) Expert Committee on the Selection and Use of Essential Medicines held on March 31 to April 3, 2003 in Geneva, Switzerland. It cites the open session held as part of the meeting, which purpose is to allow all stakeholders to participate in the discussions and to comment on issues relating to the WHO Model List of Essential Medicines.

Chapter 12 of the book "WHO Expert Committee on Specifications for Pharmaceutical Preparations" is presented. It presents information on the International Nonproprietary Names (INNs) programme and the challenges facing it in the future. It says that the priority was given to upgrading the database architecture and functionality and that a small panel of experts was established to advise on matters relating to compounds in the area of biologicals.

Chapter 11 of the book "WHO Expert Committee on Specifications for Pharmaceuticals Preparation" is presented. It highlights the drug storage conditions included in the "WHO guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms." It also offers information on a programme on International Nonproprietary Names (INN).