Drugs performance tests

Effectiveness of TB therapy is determined by AFB smears and cultures. Sputum samples should be sent for AFB staining and microscopic examination (smears) every 1 to 2 weeks until two consecutive smears are negative. This provides early evidence of a response to treatment.28 Once on maintenance therapy, sputum cultures can be performed monthly until two consecutive cultures are negative, which generally occurs over 2 to 3 months. If sputum cultures continue to be positive after 2 months, drug susceptibility testing should be repeated, and serum concentrations of the drugs should be checked. 

Variation of temperature is usually not an issue for solid oral dosage forms, since experiments are always conducted at body temperature (37°C). For dosage forms applied on the skin, this can be a further consideration e.g., drug-release testing of transdermal products is typically performed at the average temperature of body surface 32°C (5). 

Drug Development Tests are performed on the lead compounds in test tubes (laboratory, in vitro) and on animals (in vivo) to check how they affect the biological systems. The tests, often called preclinical research activities. 

The National Institute for the Control of Pharmaceutical Biological Products (NICPBP) performs tests on the drug samples submitted. Based on the test results and the report from the CDE, the DDR approves the conduct of clinical trials at designated hospitals in China (Fig. 8.13). 

Methods used to determine the performance characteristics of finished products fall into Category III. Dissolution tests (excluding measurement) and drug release tests are examples of these types of methods. Precision is the only parameter required for these methods according to the regulatory guidances, although all validation parameters may be determined based on the intent of the method. 

Dissolution testing, a routine requirement for tablets and capsules, is one of the most frequently performed tests in the pharmaceutical laboratory. It measures the dissolution of active drugs from solid dosage forms under standardized conditions. It is a tedious and... 

The evolution and optimisation of a formulation is an experimental stage that will be conducted on small batches of the material. For a drug with a tablet weight of 250 mg, test batches would t)rpically be 0.5-1 kg, providing up to 4000 tablets for analysis, performance testing and initial stability studies. Similar scales will be used in the optimisation of the product s packaging. 

Drug/Lab test interactions Naproxen use may result in increased urinary values for 17-ketogenic steroids. Temporarily discontinue naproxen therapy 72 hours before adrenal function tests are performed. 

Drug/Lab test interactlons Su tor am 6es may produce false-positive urinary glucose tests when performed by Benedict s method. Sulfisoxazole may interfere with the Urobilistix test and may produce false-positive results with sulfosalicylic acid tests for urinary protein. 

The medical records of the volunteers who received cholinesterase-reactivating chemicals consisted of the test protocol, physicians orders, nursing notes (Including clinical observations), a checklist of symptoms, and laboratory and performance test results. The reports of physicians examinations and physical findings were generally not Included. Volunteers were identified by number. The Committee on Toxicology s assessment was based on records and summaries provided by the Department of the Army and NRC staff. The procedures were described fully in Volume 1. In most cases, the analysis was based on summaries of drug administrations prepared by a consultant to the Panel. 

Illicit drugs are usually quickly metabolized so it is necessary to perform testing a few hours after intake. In plasmatic analysis the possibility for adulteration is very low and so blood samples have always been considered for forensic analysis. 

---