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Abbreviation | Full Form |
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| Active delivery systems | Targeted drug delivery systems, a method of delivering medication (active ingredient) to a patient's organism optimally - in a manner that increases the concentration of the medication in some parts of the body relative to others. |
| Active Ingredient | Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and are present in the drug product in a modified form intended to furnish the specified activity or effect. |
| API (Active Pharmaceutical Ingredient) | Also called Drug Substance. Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that when used in the production of a drug becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. |
| API sourcing | Finding, evaluating and engaging suppliers of pharmaceutical active ingredients (API) |
| Biotechnology | A kind of technology that uses biological systems, dead organisms, or derivatives thereof, to make or modify products or processes for specific use. It has three main applications: medicine, agriculture, environmental and non-food (industrial) areas. At present bioproducts can be used in many areas of biomedicine such as pharmacogenomics, molecular markets, targeted therapies, diagnosis and personalised medicines, as well as the food industry (e.g. functional food and nutraceuticals). |
| CEP | Certificate of Suitability of Monographs of the European Pharmacopoeia |
| CDER (Center for Drug Evaluation and Research) | The successor to the Bureau of Drugs of the FDA concerned with all SVPs (Small Volume Parenterals), LVPs (Large Volume Parenterals), and non-biological drugs. |
| cGMP (current Good Manufacturing Practices) | Current accepted standards of design, operation, practice, and sanitization. The FDA is empowered to inspect drug-manufacturing plants in which drugs are processed, manufactured, packaged, and stored for compliance with these standards. |
| Clinical trial | A research program conducted with patients to evaluate a new medical treatment, drug, or device the purpose of the clinical trial is to find new and improved methods of treating different diseases and special conditions. |
| CNS | Central Nervous System |
| Dosage Form | The form in which the drug is delivered to the patient. This could be parenteral, topical, tablet, oral (liquid or dissolved powder), suppository, inhalation, transdermal, etc. |
| Drugs | Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals. |
| Drug development industry | Drug development is a complex activity, consisting of medical and laboratory expertise, including toxicology, preclinical evaluation, clinical trial design and implementation. It is aimed at improving the safety and efficacy of new drugs before they come to market |
| EDMF | European Drug Master File |
| FDA | US Food and Drug Administration |
| FDA Form 483 | The official form of notification prepared at the conclusion of an inspection (without review by FDA management) listing observations of perceived violations of Good Manufacturing Practices that may constitute violations of law in the opinion of an inspector. Originally intended to inform companies of possible product adulteration, they must be replied to satisfactorily and/or corrective action taken in order to alleviate any offensive notification and avoid action from the FDA (i.e., plant shut-down). Accessible through the Freedom of Information Act to competitors, potential customers, and the media; 483s can lead to withholding of product approvals, may come into play in due diligence phases of acquisitions and mergers, and can potentially cost companies money. |
| Finished form of drugs | A form in which a drug is produced and dispensed e.g. capsules, tablets |
| GCP | Good Clinical Practice |
| Generic drugs | The equivalents of innovative medicines marketed, in the majority of cases, after the latter's patent expiration. They have the same quality, safety and therapeutic efficacy, intended use, dosage, active pharmaceutical substance and pharmaceutical form as the originator product. |
| GMP rules | Rules of Good Manufacturing Practice. It is one of the most important elements of quality assurance in the global pharmaceutical industry. Its main aim is to ensure that products are manufactured and controlled in accordance with the quality standards appropriate for their intended use and the required marketing authorisation in order to minimise risks in any pharmaceutical production. |
| Healthcare market | In value terms: value of all healthcare procedures provided to patients by healthcare facilities (in-patient and out-patient) in an analysed period of time. The can be financed through both public and private funds. |
| Injection | A preparation intended for parenteral administration and/or constituting or diluting a parenteral article prior to administration. The introduction of parenterals may be into the subcutaneous cellular tissue (subcutaneous or hypodermic), or the muscular tissue (Intramuscular). |
| Innovative medicines | The first version of a drug which is developed and patented by an originator company. The product is covered by exclusive rights to marketing. |
| Medical devices | A group of medical products used mainly in diagnostics but also in treatment, including the performance of various medical procedures. It may be an instrument, apparatus, appliance, software, material, implant, in vitro device or any other related article. |
| New Drug Application (NDA) | The New Drug Application contains most of the information included in the IND. Only after FDA approval of the NDA, can distribution and marketing of a new drug begin. |
| OTC | Over-the-counter products i.e. products sold without a prescription (OTC drugs, dietary supplements and other medicinal products) |
| Oral Product | A pharmaceutical product meant to be introduced through the mouth in the form of a tablet, capsule, or suspension. |
| Pharma market (pharmaceutical market) | The value (and volume) of drugs and other health-related products (such as parapharmaceuticals) sold in pharmacies, non-pharmacy channels (such as retail shops), through the internet as well as those purchased by hospitals and other healthcare facilities. The pharmaceutical market can also be understood in terms of the value (and volume) of drugs sold by wholesalers to pharmacies or by manufacturers to wholesalers. |
| Pharmaceutical contract manufacturing | Manufacturing of medicines or their components for another company |
| Pharmacy | 1) a retail outlet where drugs are sold/given to patients; pharmacies usually sell Rx, OTC drugs, parapharmaceuticals such as dietary supplements, dermocosmetics, as well as dressing, toothpastes and medical devices; 2) a branch of medical and chemical sciences which deals with medications, their application, composition etc. |
| Private healthcare market | The private healthcare market comprises: payments for drugs and medical equipment directly from patients' pockets, cost of rehabilitation, diagnostic tests and doctors' appointments covered directly from patients' pockets, undocumented payments (the grey economy) e.g. so-called tokens of gratitude for medical staff, subscriptions offered by medical companies together with occupational healthcare services, health insurance offered by insurance companies, other payments covered directly by patients. |
| RX drugs | prescription medicines |
| Supply chain management | The supply chain is understood as a network of flows from initial suppliers to final recipients. This network covers flows in supplies, production, distribution and other flows related to customer service, operations regarding research, development, marketing etc. Supply chain management, if defined in this way, consists of the integration of key processes from supplier to final user in order to add value to products, services and information. |
| Synthesis | Creating products through chemical and enzymatic reactions. |
| USDMF | United States Drug Master File |
| test | just for test |
