Protocol, clinical evaluation, drugs

Medical/clinical reviewers, often called medical officers, are almost exclusively physicians. In rare instances, nonphysicians are used as medical officers to evaluate drug data. Medical reviewers are responsible for evaluating the clinical sections of submissions, such as the safety of the clinical protocols in an IND or the results of this testing as submitted in the NDA. Within most divisions, clinical reviewers take the lead role in the IND or NDA review and are responsible for synthesizing the results of the animal toxicology, human pharmacology, and clinical reviews to formulate the overall basis for a recommended agency action on the application. 

Study design plays a critical role in the clinical evaluation of drugs. A clinical study cannot be conducted without specifically outlined objectives and a definitive plan, which are vital components around which the study protocol is constructed. The use of placebo or active drug control groups in the study, and whether the design should be open, parallel, or crossover, must be determined. In most studies, patients are assigned to study groups randomly. 

Education of pharmacy students emd residents Implements and evaluates drug therapy protocols or pathways Participates in clinical research... 

A multidisciplinary team works in coordination, sharing both patients and responsibility, both in the patient s direct care and in planning such care. Quality is defined in care planning, such as clinical sessions, elaboration, implementation, follow-up and evaluation of protocols, clinical paths and clinical guidelines, participation in different clinical commissions, and so on. Clinical pharmacists must be recognized as leaders in all drug-related aspects. It is not a right, it must be earned. 

PROPOSED CLINICAL EVALUATION PROTOCOL FOR THE DEVELOPMENT OF AN HERBAL DRUG ... 

During the clinical trial phase, the sponsor and FDA will meet on one or more occasions. A particularly important meeting is often the end of phase II meeting. This aims primarily to evaluate and agree upon phase III plans and protocols. This is particularly important, as phase III trials are the most costly and generate the greatest quantity of data, used later to support the drug approval application. 

Compounds tested in a more physiological 3-D environment show increased predictability of in vivo responses and help to span the gap between 2-D tissue culture and animal models. There is also evidence that 3-D cultures can identify active compounds that would fail to show their potential in 2-D (56, 57). The complexity of 3-D cultures can be increased by the addition of one or more cell types (fibroblasts, endothelial cells) and/or culture with different media, substrates, or oxygenation conditions. However, a disadvantage is that there is still a lack of simple, standardized, and reliable 3-D protocols that allow their incorporation into the pre-clinical high-throughput validation and drug evaluation process, although there have been several advances in this area in recent years (30, 58-61). 

Both pre-clinical and clinical trials are underpinned by a necessity to produce sufficient quantities of the prospective drug for its evaluation. Depending on the biopharmaceutical product, this could require from several hundred grams to over a kilo of active ingredient. Typical production protocols for biopharmaceutical products are outlined in detail in Chapter 3. It is important that a suitable production process be designed prior to commencement of pre-clinical trials, that the process be amenable to scale-up and, as far as is practicable, that it is optimized (Figure 2.9). The material used for pre-clinical and clinical trials should be produced using the same process by which it is intended to undertake final commercial-scale manufacture. 

The preclinical stage of drug development focuses on activities necessary for filing an IND/CTA. The completed IND/CTA contains information that details the drug s composition and the synthetic processes used for its production. The IND/CTA also contains animal toxicity data, protocols for early phase clinical trials, and an outline of specific details and plans for evaluation. Process research, formulation, metabolism, and toxicity are the major areas of responsibility in this development stage. Analysis activities that feature LC/MS primarily focus on the identification of impurities, de-gradants, and metabolites. 

---