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Bioequivalence Testing
Published in Sarfaraz K. Niazi, Handbook of Pharmaceutical Manufacturing Formulations, Third Edition, 2019
The pharmacotherapeutic nature of the drug plays an important role in the regulations regarding its bioavailability. Drugs which exhibit narrow therapeutic index, that is, less than a twofold difference between median lethal dose and median effective dose values (or less than a twofold difference between the minimum effective concentration and the minimum toxic concentration in the blood) require careful demonstration of bioavailability and the consistency with which this requirement is met. Further consideration is needed regarding the type of side effects occurring if a toxic level is reached. For example, the therapeutic index (the U.S. FDA prefers to call this the therapeutic range) for salicylates is smaller than that for cardiac glycosides; this does not mean that cardiac glycosides are less toxic. It merely signifies that the concentration of salicylates for therapeutic response is closer to the concentration at which undesirable side effects start to appear. Another consideration along the same line is the potency of the drug in question. Generally, highly potent drugs will require greater control of bioavailability than drugs with lower potency. Because of the logarithmic nature of the response, the curves flatten out at low and high doses. Thus, a highly potent drug used in large doses will show a lower variability in response due to bioavailability factor than a low-potency drug used at a dose level where the response is log-linear. Any such comparison, however, should take into account the relative nature of the slope of the response to dose.
FDA regulatory guidance
Published in Sarfaraz K. Niazi, Biosimilars and Interchangeable Biologics, 2016
“Potency” means the product’s “specific ability or capacity to effect a given result” based on laboratory testing or controlled clinical data. Thus, the agency has interpreted “potency” to include effectiveness. Nevertheless, the FDCA’s requirement for “adequate and well-controlled trials,” which typically means at least two pivotal clinical studies, does not apply to biologics in all circumstances. Instead, this is a default requirement for biologics. Proof of efficacy must comprise adequate and well-controlled trials unless the sponsor shows that this requirement (1) “is not reasonably applicable” to the biologic or “essential to the validity” of the trial and (2) an alternative method is “adequate to substantiate effectiveness.” For example, serologic response evaluations may be sufficient when the correlation between the marker and clinical effectiveness has been established.
Sources and Characteristics of Contaminant Particles
Published in Thomas A. Barber, Control of Particulate Matter Contamination in Healthcare Manufacturing, 1999
Particle containment involves the protection of personnel from particles generated by a manufacturing process rather than protecting a process from heterogeneously sourced contaminants. Most often, the concern is to protect personnel from toxic, aerosolized drug powders (e.g., chemotherapeutic agents) or potential sensitizing agents (e.g., penicillin, cephalosporins). The mixing of two types of drugs is also a concern. “Potent” compounds are pharmaceutical chemicals that are effective in very low doses in causing a positive or negative response in a human subject. Drugs of the future will almost universally demonstrate activity at far lower doses than in the past. Such highly active compounds will present significant challenges in personnel protection.
Synthesis, molecular modeling, and biomedical applications of oxovanadium(IV) complexes of Schiff bases as a good SARS-CoV-2 inhibitor
Published in Inorganic and Nano-Metal Chemistry, 2022
Mohammad Nasir Uddin, Zainul Abedin Siddique, Jabunnisa Akter, Md. Saifur Rahman, Wahhida Shumi, Munira Nasiruddin
The LC50 and LC90 values with LC90 95% confidence limits (lower confidence limit [LCL] and upper confidence limit [UCL] were calculated and the results are given in Table 6. Analysis of relative potency values of Schiff base complexes in terms of LC50 is given in Table 5. Toxicity order on the basis of LC50 was C1 > C5 > C4 > C3 > C2. From this toxicity order, it is clear that the C1 complex was most toxic and the C2 complex was least toxic than others against the mosquito larvae, C. quinquefasciatus. Relative potency is a measure of drug activity expressed in terms of the amount required to produce an effect of a given intensity. Higher relative potency means have high drug activity.
Antiproliferative activity and human serum albumin binding propensity of [SnMe2Cl2(bu2bpy)]: multi-spectroscopic analysis, atomic force microscopy, and computational studies
Published in Journal of Coordination Chemistry, 2020
Nahid Shahabadi, Saba Zendehcheshm, Badri Z Momeni, Reyhaneh Abbasi
Drug potency is expressed in terms of IC50 value (50% inhibitory concentration) calculated from the plotted dose-effect curve (through least-square regression analysis). Moreover, a phase contrast inverted microscope equipped with a digital camera (Olympus IX51, Tokyo, Japan) was employed at 100 × magnification to observe the morphological changes in the cancer cells after incubating in the presence of various amounts of Sn(IV) complex.