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At least 19 recordsLinked to original sources
PubMed1990

An overview of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations.

The history, purpose, and content of FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") are described. When cost guidelines established in the 1970s for Medicare reimbursement prompted most states to permit generic drug product selection, an official list of interchangeable drug products was needed. Regulations for determining bioavailability and bioequivalence were published in 1977, and FDA first published Approved Drug Products in 1980. The Orange Book includes products that have been fully reviewed by FDA for both safety and effectiveness and for which new drug applications (NDAs) or abbreviated new drug applications (ANDAs) and special applications (From 5s or 6s) for antibiotics have been approved. Pursuant to the 1984 Drug Price Competition and Patent Term Restoration Act, FDA added approved nonprescription products to the Orange Book along with information about patents and periods of marketing exclusivity. Orphan drug products and certain testing and application procedures are also provided. Equivalence evaluations are provided in the Orange Book only for multisource prescription drug products that contain the same active ingredients and can be expected to have the same clinical effect when administered to patients under the conditions specified in the labeling. A coding system is used to indicate the products' equivalence evaluations according to FDA criteria, and indexes by product name and manufacturer are included. Monthly Cumulative Supplements are issued. The Orange Book contains public information and advice, but it is not an official national compendium; FDA has no position on state regulation of drug product selection by pharmacists. The equivalence evaluations do not relieve practitioners from exercising care in prescribing and dispensing products according to patients' individual needs.

Drug Information Services↗
PubMed1980

Availability and usage of new antibacterial drugs in Europe.

The present-day availability and usage of established and new antibacterial drugs approved for clinical and therapeutic purposes in food-producing animals and poultry in the United States and Europe were compared. Presently, 42 such drugs are approved in Europe, 13 of which were approved since Dec 31, 1974. In the United States, 17 such drugs are currently approved, only four were approved since Dec 31, 1974. Most drug products approved in Europe contain two or more antibacterial agents, whereas most of the products approved in the United States are single drug entities. Drugs approved in Europe but not in the United States include sulfonamide and trimethoprim combinations, nafcillin, oxacillin, metampicillin, cephoxazole, cephalonium, cephacetrile, cephalexin, gentamicin, rifamycin SV, nifuroquine, tiamulin, chloramphenicol, colistin, and polymyxin B. Pharmacologic and clinical features of several of these drugs are briefly described.

Animal Diseases↗
PubMed1990

Successful development of recombinant DNA-derived pharmaceuticals.

Successful development of recombinant DNA-derived pharmaceuticals, a new class of therapeutic agents, is determined by a variety of factors affecting the selection and positioning of the compound under development. For an efficient development it is of utmost importance that the mechanism of action of the compound selected be understood on a molecular level. The compound's potential therapeutical profile and a strong patent position are key positioning considerations, as well as vital elements in shortening the development phase and protecting innovation. Installation of an interdisciplinary project management team, along with a clear definition of team members' responsibilities, is required to avoid delays and improve communication during development. Selection of the organism to be used in production must take into consideration both the structure of the protein and the quality and safety of the final product. New technologies require a considerable investment in new manufacturing facilities and equipment. Often, the decision for such an investment must be made early and with a high degree of uncertainty. Desired product yield, expected dosage, and estimated market potential are the most important considerations in this decision. Following public disclosure of the plan to develop recombinant DNA-derived products, approval of the production plant and expansion or adaptation to the new process and technology may be delayed. For this reason, they should be considered as a critical step in the overall development phase. Recruitment of qualified staff is a time-consuming and critical element of the production process. Its impact on the product timeline should not be underestimated, especially if such technologies are new to the company. The entire production process must be validated in respect to identity, purity, and safety of the product to guarantee constant product quality, as well as for safety aspects in the environment. Adequate in-process and final product controls have to be established and specifications determined for release or rejection of batches for preclinical and clinical studies as well as for marketing. Preclinical testing is limited because recombinant DNA-derived proteins cannot be differentiated from naturally occurring human proteins, and because some proteins are species-specific.

DNA, Recombinant↗
PubMed1992

Interim report of the ad hoc committee for the consideration of statistical concerns related to the use of intra-oral models in submissions for product claims approval to the American Dental Association.

Subsequent to the American Dental Association Symposium on Intra-oral Studies, held in Chicago in September, 1990, the Council on Dental Therapeutics decided that further consideration should be given to statistical issues relating to intra-oral models. The authors accepted the request of Council staff to assist in the development of Guidelines concerning the validity, reliability, and combinability of data obtained from these models. The ensuing work in this area, which began in the fall of 1990 and has continued to date, has thus far focused on the tissue of validity. The purpose of the present paper is to provide the interested community at large with an update on the progress made thus far, and to provide some perspective as to where all of the work in this area may eventually be leading. It is anticipated that a more comprehensive and definitive report will be produced at the completion of this process.

American Dental Association↗
PubMedDate not supplied

Bioequivalence requirements for generic products.

Many countries have established procedures for the introduction of generic pharmaceutical products. In order to protect consumers, these generic products must be demonstrated to be therapeutically equivalent to a previously approved product, typically an innovator product. The therapeutic equivalence of a generic and an innovator product is most commonly based on the demonstration of bioequivalence, i.e. clinically insignificant differences in the rate and extent of drug absorption usually assessed from pharmacokinetic measurements. This article reviews the bioequivalence requirements for generic products and, in the interest of promoting international harmonisation, highlights those areas where differences exist among countries.

Absorption↗
PubMed1990

How important are lens oxygen ratings? Performance predictors for the concerned practitioner.

Three indices of oxygen passage exert considerable influence in contact lens practice: (a) Dk/L, which indicates the oxygen transmissivity of a lens; (b) equivalent oxygen percentage (EOP), which assesses corneal oxygen demand during lens wear; and (c) pachometry, a measure of the swelling response of the cornea to lens-induced hypoxia. These indices correlate well with one another but reflect different "time-line" values, with Dk/L and EOP giving predictive information about lens-eye interactions and pachometry reflecting actual wearing responses. Lens oxygen data hold tangible benefits for manufacturers, clinicians, and patients. They guide manufacturers in choosing which new lens materials to develop, in making decisions about physiologically acceptable lens thicknesses, in affirming safety and efficacy data, in securing Food and Drug Administration (FDA) product approval, and in presenting performance information to doctors and patients. Used effectively, such guidance should lower the cost of product development. Clinicians use lens oxygen ratings to refine their prescribing practices, thereby boosting patient satisfaction and lens wear success. Besides favoring long-term ocular health, oxygen ratings may yield an economic benefit for patients, if the savings realized by manufacturers during product development are translated into lower lens prices.

Contact Lenses↗
PubMed1990

The importance of risk assessment to the nation's health and economy.

The global marketplace is changing rapidly. Never in history has the opportunity to capture new markets with new products and new generations of products been greater. However, never has the chance of losing established markets been higher. We are failing to develop new products despite the fact that Americans have paid for the science from which the world's new technologies were developed. There are many reasons for our failure to turn scientific leads into products. One of the most obvious is that we overestimate the risk of new technologies. Present policy uses a conservatively biased risk assessment process to estimate risk. This process uses many assumptions to bridge gaps in our scientific knowledge about risk. If we wish to be competitive, we must bring safe, inexpensive new products to the marketplace faster. We must seek ways of making our policies more effective while still protecting public health. Risk assessment sets the standards for product development, product approval, and environmental release. A slight miscalculation in "safety levels" can result in tens of billions of dollars in cost added to products. These added costs have a major and direct impact on the competitiveness of U.S. products in the global marketplace where differences in consumer acceptance can be calculated in a few percentage points difference in price.(ABSTRACT TRUNCATED AT 250 WORDS)

Economic Competition↗
PubMed1986

Food Animal Residue Avoidance Databank (FARAD): a pharmacokinetic-based information resource.

The Food Animal Residue Avoidance Databank (FARAD) is a pilot project funded through the USDA Extension Service. It represents a major effort to compile into a single source large amounts of information on veterinary pharmaceutics, pharmacokinetics and physiochemical properties of drugs and other chemicals used in livestock production. FARAD is a computer-based system consisting of five data and numerous command files that access the data files to facilitate rapid input and retrieval of the desired information. The data files include proprietary information on all pharmaceutical products approved for use in food animals in the United States; physicochemical information on more than 100 chemicals contained in the databank; regulatory information pertaining to tolerance and action levels of chemical residues in animal products and allowable concentrations of drugs in feed; pharmacokinetic rate and volume constants pertinent to residue depletion modeling in a variety of species; bibliographic citations to which all of the information contained in the databank is referenced. All of the information in FARAD is currently available through three regional access centers in the United States, and direct computer access to the data may become available in the future.

Anti-Bacterial Agents↗
PubMed1991

Results of a quality-control study of lyophilized pooled plasmas which have been 'virally inactivated' using a solvent detergent method (modified Horowitz procedure).

The 'virus-free' lyophilized pooled plasmas supplied to our institute by the German Red Cross in Hagen did not meet the quality norms found in standard products. Indeed, with respect to all the major parameters, they deviated greatly from standard coagulative fresh frozen plasmas. In order to achieve a suitable substitution effect and approximate the properties of fresh plasma, it would be necessary to administer two to three times the amount of 'virus-free' plasma. At the same time it should be noted that by contrast to coagulative fresh plasma, the new product neither compensates for factors which activate or inhibit coagulation, nor for fibrinolytic factors. On the contrary, the ratio between these factors deviates dangerously from their physiological equilibrium. Grave therapeutic consequences can be expected therefrom. In addition, most of the tested batches already contain heparin in quantities within the therapeutic range in spite of the fact that the manufacturer neglects to mention this detail. Finally, the method of preparation pushes the pH values far into the alkaline range. This fact alone could have fatal consequences if this product was administered to severely ill patients. In general, we can only express our surprise that the Bundesgesundheitsamt (German Health Board), as the official body responsible for approving this product, has agreed to its distribution on the basis of notification that changes would be made to an existing approved product. The following facts, in our opinion, should have determined the renewal of the licence for sale: As opposed to the approved product--a plasma derived from individual donors--the 'virus-free' plasma is a pooled plasma. As opposed to the approved product--a deep-frozen plasma derived from individual donors--the 'virus-free' plasma is a pooled lyophilized plasma. As opposed to the approved product which is not subjected to any chemical processing, the 'virus-free' product is treated with tri(n)butylphosphate and an unspecified detergent. These virucidal properties are assumed on the basis of consequential logic rather than proven by hard experimentally determined fact. Data confirming the efficiency of the process based on legitimate animal experiments has not be presented. In spite of all the efforts to improve safety in transfusion medicine we believe that if certain nonprofit-making blood banks are to retain their credibility, they should be subjected to the same stringent laws and regulations that are applied to the rest of the German pharmaceutical industry.(ABSTRACT TRUNCATED AT 400 WORDS)

Antibodies, Viral↗
PubMed1995

Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: a regulatory perspective.

The objective of the present study was to compare the number of new chemical entities (NCEs) and new biologicals entities (NBEs) approved for marketing during the period 1974 through 1993 in the United Kingdom, the United States, and Spain that were subsequently discontinued (removed from the market, withdrawn, or whose license was allowed to lapse) while a question of safety existed. Of the products approved during the two decades of the study period, a total of 29 drugs were subsequently discontinued for safety reasons in at least one of the three countries (United Kingdom: 20 safety discontinuations; United States: 10; and Spain: 16). These represent 3% to 4% of all drugs introduced in these countries, an increase compared to the period from 1964 through 1983, when approximately 2% of all NCEs were discontinued for safety reasons. The therapeutic classes most commonly associated with safety discontinuations were the nonsteroidal anti-inflammatory drugs (nine drugs), vasodilators (four drugs), and antidepressants (three drugs). U.S. companies or their foreign subsidiaries were involved as originators (patent-holders and/or developers) of approximately 40% of the drugs discontinued for safety reasons.

Animals↗
PubMed1995

Safety evaluation of benzophenone-3 after dermal administration in rats.

Benzophenone-3 (BZ-3) is a category 1 (over-the-counter) product approved by the US Food and Drug Administration (FDA) for use as a sunscreen agent in medicine, cosmetics, industry, and agriculture. This is due to its ability to absorb and dissipate ultraviolet light in a harmless manner, thus protecting human skin and products from UV irradiation. This study investigated the safety of BZ-3 after repeated administration. BZ-3 in ointment base was applied at a dose of 100 mg/kg body wt. twice daily, for 4 weeks to the skin of male Sprague-Dawley rats. Body weight, organ to body weight ratios, hematological, and clinical chemistry parameters were not effected. Pathological examination revealed no significant changes between control and treated animals. No gross external abnormalities were observed. Both in vivo and in vitro blood glutathione (GSH) levels were effected by BZ-3 treatment. However, after 60 min of incubation, a reversal of this effect was observed in the treatment group as blood GSH levels approached normal levels. Furthermore, investigation of GSH-reductase and peroxidase with time indicated an increase in GSH-reductase activity at 60 and 90 min with no effect on GSH-peroxidase. Pre-treatment with phenobarbital modulated the metabolic disposition of BZ-3. There was an increase in the formation of the hydroxy metabolites but not the O-dealkylated form. This study suggests that BZ-3 is not toxic to rats when applied dermally at a dose of 100 mg/kg body wt. for 4 weeks.

Administration, Cutaneous↗
PubMed1993

Biotechnology: an introduction to recombinant DNA technology and product availability.

Exciting advances in biotechnology have led to the development of innovative biological products to improve health care. In this review article, the major techniques of product development and manufacturing in biotechnology are discussed, with a focus on recombinant DNA technology. In addition, monoclonal antibody, nucleotide blockade, polymerase chain reaction, antisense, and gene therapy technologies will be defined briefly. For recombinant-DNA technology, the issues of gene isolation, gene cloning, protein expression, scale-up (manufacturing), and quality assurance are addressed. The 16 approved products and the research pipeline are characterized. In addition, major usage issues for biological products are noted. This review serves as an introduction to the science and applications of biotechnology present and future.

Biotechnology↗