临床研究基于临床前药学、药效学、药动学及安全性评价进行设计和实施，给药

Clinical research is designed and implemented based on preclinical pharmacy, pharmacodynamics, pharmacokinetics, and safety evaluation. The route of administration should be consistent with preclinical, and the product to be marketed should be consistent with the route of administration for clinical research and registration applications. <br>Bioavailability and in vitro dissolution profile are consistent with clinical research batches. <br>For the purpose of quality consistency, production process development, methods, and production process verification should meet the same quality standards as clinical research batches (such as identification, content, purity, and quality ) <br>Appropriate container sealing system is adopted to ensure the integrity of the target product's shelf life and transportation process <br>based on the stability results of registered batches and clinical batches, the packaging material is polyamide / aluminum / polyvinyl chloride cold stamped solid pharmaceutical compound Hard film and medicinal aluminum foil. <br>Other optional usage and dosage selection <br>clinical studies have not carried out other methods of administration <br>3.2.P.2.3.2 The key quality attributes (CQAs) of the target product are <br>based on the analysis of the target product quality profile of aftinib mesylate tablets. This product, physical properties (size and traits), content, content uniformity (less than 25% of the main drug), drug dissolution are part of the CQAs that may be affected by process variables, detailed study in process And discussion. <br>On the other hand, CQAs that are not susceptible to process variables, such as identification, residual solvents and microbial limits, are not discussed and studied in detail. <br>However, these CQAs are still the target elements of QTPP, and are guaranteed through good drug quality systems and control strategies. <br>In Table 3.2.P.2.3-3, the quality attributes of aftinib mesylate tablets are summarized, and which are CQAs are indicated. <br>CQA or not <br>The color and shape of the patient and the tablets received, no visible one-sided defect <br>color and shape are not directly related to safety and effectiveness. <br>So these are not key quality attributes, the goal setting is just for patient compliance. <br>No unpleasant smell<br>In general, unpleasant odors are not directly related to the safety and effectiveness of drugs, but odors may cause discomfort to patients' compliance with medication. <br>For this product, neither raw materials nor accessories are unpleasant. <br>This product is consistent with clinical research batches. <br>The size of 8mm round tablets is related to the difficulty of swallowing, so it should be a key attribute.

Clinical research is designed and implemented on the basis of preclinical pharmacology, pharmacodynamics, pharmacodynamics, pharmacodynamics and safety evaluation, and the route of administration should be consistent with preclinical, and the intended products should be consistent with the path of administration of clinical research and registration applications.<br>Bioavailability and in vitro solute curves are consistent with batches for clinical studies<br>For quality consistency, production process development, methods, and production process validation should meet the same quality standards (e.g. identification, content, purity and quality) with clinical research batches<br>Appropriate container sealing systems are used to ensure the integrity of the target product shelf life and transportation<br>Based on the results of registered batch and clinical batch stability, the packaging material is polyamide/aluminum/PVC cold stamping solid medicinal composite tablets and medicinal aluminum foil.<br>Other optional usage and usage options<br>No other drug use has been carried out in clinical studies<br>3.2.P.2.3.2 Key Quality Properties for Target Products (CQAs)<br>Based on the analysis of the product quality profile of the target products of the methafsultine eflutinib tablets, the physical properties (size and character), content, content uniformity (less than 25% of the main drug), drug melting is part of CQAs that may be affected by process variables, and is studied and discussed in detail in the process research.<br>On the other hand, CQAs, such as identification, residual solvents and microbial limits, which are not susceptible to process variables, are not discussed in detail and studied.<br>However, these CQAs remain the target element of QTPP and are guaranteed through good drug quality systems and control strategies.<br>In Table 3.2.P.2.3-3, the quality properties of the methafluotinib tablet are summarized and what is CQAs are noted.<br>CQA or No<br>The color and shape of the patient and the pill received, without visible one-sided defects<br>Color and shape are not directly related to safety and effectiveness.<br>Therefore, these are not key quality attributes, the goal is set only for patient compliance.<br>No unpleasant smell<br>In general, unpleasant odors are not directly related to the safety and effectiveness of the drug, but odors may cause discomfort in patients' medication compliance.<br>For this product, both raw materials and accessories are not pleasant smell.<br>This product is consistent with the clinical study batch and is 8mm round<br>The size of the tablet is related to the ease of swallowing, so it should be a key attribute.

Clinical research is designed and implemented based on preclinical pharmacy, pharmacodynamics, pharmacokinetics and safety evaluation. The route of administration should be consistent with preclinical administration, and the products to be marketed should be consistent with the route of administration of clinical research and registration application.<br>Bioavailability and dissolution curve in vitro are consistent with batches for clinical study<br>For the sake of quality consistency, production process development, method and production process validation shall meet the same quality standard (such as identification, content, purity and quality) as the clinical study batch<br>Appropriate container sealing system is adopted to ensure the shelf life and integrity of the target product during transportation<br>Based on the stability results of registered batch and clinical batch, the packaging materials are polyamide / aluminum / PVC cold stamping solid medical composite hard disk and medical aluminum foil.<br>Other optional usage and dosage selection<br>No other administration methods in clinical study<br>3.2. P.2.3.2 key quality attributes (CQAs) of target products<br>Based on the analysis of the quality profile of the target product of efetinib mesylate tablets, for this product, the physical properties (size and properties), content, content uniformity (the proportion of the main drug is less than 25%), drug dissolution is a part of CQAs that may be affected by process variables, and it is studied and discussed in detail in the process research.<br>On the other hand, CQAs that are not easily affected by process variables, such as identification, residual solvents and microbial limit, are not discussed and studied in detail.<br>However, these CQAs are still the target elements of qtpp and are guaranteed through good drug quality system and control strategy.<br>In table 3.2. P.2.3-3, the quality attributes of efetinib mesylate tablets are summarized, and which CQAs are indicated.<br>CQA or not<br>The color and shape of the patient and the tablet received, without visible unilateral defects<br>Color and shape are not directly related to safety and effectiveness.<br>Therefore, these are not key quality attributes, and the goal setting is only for the patient's compliance.<br>No unpleasant smell<br>Generally speaking, unpleasant smell is not directly related to the safety and effectiveness of drugs, but it may cause discomfort to patients' drug compliance.<br>For this product, no matter it is raw material or auxiliary material, there is no unpleasant smell.<br>This product is the same as the clinical study batch, 8mm Round film<br>The size of tablet is related to the difficulty of swallowing, so it should be a key attribute.<br>