Conventional Medicine and QbD - Essay Example

Haemopaths saw such symptomatic treatments as “opposites treating opposites” and believed these conventional methods were harmful to patients (Dalmaso, 2008). Therefore, Conventional medicine was used to refer to a system of medicine that combats diseases by using remedies that produce effects in a healthy subject that are different from the effects produced by the disease to be treated. As used by homeopaths, allopathy has always referred to the principle of curing disease by administering substances that produce other symptoms when given to a healthy human than the symptoms produced by a disease. For example, part of conventional treatment for fever may include the use of a drug which reduces the fever while also including a drug such as an antibiotic that attacks the cause of the fever such as a bacterial infection. Many conventional medical treatments do not however fit to be allopathy as they seek to prevent illness or remove the cause of an illness by acting on the etiology of disease (Rathore & Winkle, 2009). Due to these evidences the conventional method of medicine preparation faded away as it was traditional and replaced by Quality by Design (QbD). The QbD is a systemic approach to pharmaceutical development whereby it involves designing and developing formulations and manufacturing processes to ensure predefined product quality. An example of QbD method includes granulation among other processes. Some of the questions by design elements include; defining target product quality profile; designing product and manufacturing processes; and identifying critical quality attributes, process parameters, and sources of variability. By using QbD, pharmaceutical quality is assured by understanding and controlling formulation, manufacturing variables and product testing which confirms the product quality. Implementation of QbD enables transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment. According to Borman (2007), quality by design is a systematic approach to drug development which begins with predefined objectives and uses science and risk management approach to gain product and process understanding and ultimately process control. The concept of QbD can be extended to analytical methods and mandates to definition of a goal for the method and emphasizes thorough evaluation scouting of alternative methods in a systematic way to obtain optimal method performance. Candidate methods are then carefully assessed in a structured manner for risks and are challenged to determine if robustness and ruggedness criteria are satisfied. The main goal of QbD is to embed quality into pharmaceutical products to ultimately protect patients’ safety. Drug development using the principles of QbD emphasizes a systematic approach atarting with predefined objectives and applying scientific understanding and risk management approaches. Two concepts are applied in QbD which where by the first concept is design space which generally involves the identification of critical attributes for the input materials, the process and the final product. Applications of traditional analytical methods ...Show more