preclinical studies principles of drug discovery and development drug development drug discovery clinical trials clinical research process filing new drug application contents of nda fda nda application new drug application nda finished product quality control test in process quality control ipqc parentrals ipqc opthalmic ipqc creams fpqc ipqc trademarks patents copyrights ip intellectual property rights intellectual property ipr manufacturing industry drug industry manufacturing process design location gmp regulations cgmp gmp drug industry design drug industry location submission to ctd format control strategy design space critical quality attributes quality target product profile pharmaceutical development annex quality risk management pharmaceutical development ich q8 new drug substance or drug product new drug substance international council for harmonisation ich guidelines on drug stability drug stability ich q1(r2) ich q1 electronic signatures electronic records regulations on electronic records and electronic s united states food and drug administration (fda) part 11 cfr 21 part 11 cfr 21 cfr code of federal regulations nabl certification nabl accreditation international laboratory accreditation cooperation asia pacific laboratory accreditation cooperation mutual recognition arrangement (mra) nabl schemes conformity assessment bodies nabl national accreditation board for testing and calib nernst equation indicator electrodes reference electrodes potentiometric measurements specific ion electrode (sie) ion-selective electrode (ise) electroanalytical chemistry potentiometry
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