Drug Distribution ,Drug Excretion, Active Transport; P–gp, BCRP, Nucleoside Transporters, hPEPT1, ASBT, OCT, OATP, BBB– Choline Transporter. ICH GUIDELINES Q S E M & REGULATORY REQUIREMENTS OF EU, MHRA, TGA & ROW COUNTRIES Validation ( process validation, TT from R&D to pilot plant) 
